Assessing Clinical Research Infrastructure Needs

May 2013Authors:

Allison Orechwa, Ph.D.Melanie Funes, Ph.D.

Susan Autry, MBA

CLINICAL RESEARCH INFRASTRUCTURE NEEDS

SURVEY RESPONSE REPORT

Responses fromUSC Health Sciences

Faculty and Staff

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3 Executive Summary

4 Introduction

5 Describing the Sample

7 Clinical Data Warehouse for Research

10 Clinical Trials Management System

11 Biorepository

12 Southern California Clinical and Translational Science Institute

14 Perceived Challenges in Conducting Clinical Research

16 Appendix A: Full Survey

22 Appendix B: CDWR – Other Types of Data

23 Appendix C: CDWR – Other Feedback and Concerns

25 Appendix D: CTMS – Other Feedback and Concerns

26 Appendix E: All Perceived Challenges

Table of Contents

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Executive Summary

139 volunteers

Th ere is signifi cant interest across the USC enterprise in the development of a clinical data warehouse for re-search (CDWR) and a clinical trials management system (CTMS). Th is survey was created to gather input from potential users in order to inform the development of these new tools. Selected fi ndings include:

Th e biggest perceived challenges among the clinical research community are: Administrative hurdles (men-tioned by 26% of faculty respondents), Funding (24%), Access to clinical data or specimens (21%), and Clinical research support staff (21%).

Ninety percent of faculty respondents said that having access to clinical data from the Keck Medical Center is important to their research; 57% said access is criti-cally important.

Eighty-one of the 126 faculty (64%) indicated that using the CDWR for Historical data extraction for retrospec-tive studies was critically important to their research. Th e next most highly rated purposes were Health out-comes research (48%) and Identifi cation of potential participants in on-going or planned clinical trial (42%).

Of the diff erent types of data that could be included in a CDWR, fi ve were rated as Critically Important by at least 50% of faculty: Demographics, Diagnoses, Proce-dures, Laboratory test results, and Outcomes.

Th e highest-rated capabilities of a CTMS, in terms of importance to faculty research, were Patient Manage-ment and Biorepository Management (44% and 40% of faculty selected Critically Important, respectively). Th e top two components according to staff were Pa-tient Management and Study Management (63% each).

Th irty-fi ve percent of faculty rated a structured biore-pository as Important to their research, and 38% rated it as Critically Important.

When asked about resources and services off ered by the Southern California Clinical and Translational Science Institute, over 50% of faculty rated pilot fund-ing, informatics consultations, and assistance in the design, conduct, and management of human studies as Important or Critically Important to their research.

Seventy percent of respondents (139 individuals) said they want to be involved at some level (i.e., participat-ing in working or advisory groups) in the development of the CDWR or the CTMS.

“Development of a useful and accessible data-base is critical to my research.”

- USC health sciences faculty member

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Introduction

PurposeTh ere is signifi cant interest across the USC enterprise in the development of a clinical data warehouse for research (CDWR) and a clinical trials management system (CTMS), which are essential to providing clin-ical trial data management solutions and enhancing the competitiveness and impact of clinical research at USC. Th is survey was created to gather input from potential users in order to inform the development of these new tools, including their functionality and in-tended use. Th e survey was broadened to also identify the biggest challenges in conducting clinical research and assess the importance of existing and potential clinical and translational research infrastructure.

Survey DevelopmentSC CTSI staff worked with faculty researchers, senior university leadership, and other representatives of the clinical and translational science community to de-velop the survey. Th e fi nal survey contained questions pertaining to a CDWR, a CTMS, and general needs for clinical research infrastructure, with the hope that a single set of responses would serve multiple eff orts. See Appendix A for the full survey.

AudienceTh e intended audience for the survey was all faculty and staff at USC and its partner institutions who conduct or support clinical and translational research (staff responses were excluded from the CDWR and biorepository analyses because those questions per-tained mostly to faculty). Th e survey was therefore distributed via email listservs to the following groups: faculty and staff in the Schools of Medicine, Dentistry, Gerontology, Pharmacy, Public Policy, and Social Work; the Biomedical Engineering department within the School of Engineering; the USC Norris Compre-hensive Cancer Center; Children’s Hospital Los Ange-les. A few key groups were also contacted directly by SC CTSI’s director, including investigators who were previously served by SC CTSI.

USC Health SciencesMedicine

Dentistry

Gerontology

Pharmacy

Public Policy

Social Work

Biomedical Engineering

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Describing the Sample

Of the 201 individuals who completed the survey, 127 were faculty, 63 were staff , and 11 were “other” (e.g., student, adjunct instructor). When asked to indicate their role and primary activity, 12% of respondents selected Basic researcher, 24% selected Clinician researcher (>15% spent on research), and 11% selected

Translational researcher. Forty of the 63 staff respon-dents (63%) selected Clinical research support as their role and primary activity. Th e majority of respondents were located on the Health Science Campus and affi li-ated with the School of Medicine.

Th e sample includes 94 faculty who conduct research at USC.

Role Number ofRespondents

% of Total

Faculty 127 63%RankAssistant Professor 52 26%Associate Professor 28 14%Professor 42 21%Other or No Response 5 2%Primary ActivityBasic researcher 24 12%Clinician (0 15% spent on research) 28 14%Clinician researcher (>15% spent on research) 48 24%Translational researcher (early stage development) 22 11%

Device development 6 3%Drug development 5 2%Other or No Response 11 5%

Other or No Response 5 2%

Staff 63 31%Primary ActivityClinical research support 40 20%Other research support 18 9%Other or No Response 5 2%

Other 11 5%

Total 201 100%

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Describing the Sample (cont’d.)

Number ofRespondents

% of TotalNumber of

Respondents% of Total

CampusUSC Health Sciences Campus 81 40% 53 26%USC University Park Campus 17 8% 6 3%CHLA Children's Hospital Los Angeles 25 12% 2 1%Other or No Response 4 2% 2 1%

SchoolDentistry (including Physical and Occupational Therapy) 14 7% 4 2%Engineering (Biomedical Engineering only) 5 2%Gerontology 4 2% 3 1%Medicine 94 47% 38 19%Pharmacy 5 2% 3 1%Social Work 5 2% 1 0%Other or No Response 14 7%

Cancer Center AffiliationYes 42 21% 32 16%No 84 42% 31 15%

Affiliation Faculty Staff

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64% of faculty say historical data ex-traction from a CDWR is critically

important to their research.

Clinical Data Warehouse for Research

CDWR purposesFollowing a brief description of a clinical data ware-house for research (CDWR), respondents were asked, “For what purpose(s) would you use a clinical data warehouse?” Th ey were instructed to rate each pur-pose in terms of its importance to their research (Would Not Use It for Th is Purpose, Minimally Im-portant, Important, or Critically Important/Essential).

Eighty-one of the 126 faculty who responded to the question (64%) indicated that using the CDWR for Historical data extraction for retrospective studies was Critically Important to their research. Th e next most highly rated purposes were Health outcomes research (48%) and Identifi cation of potential participants in

on-going or planned clinical trial (42%). All other options provided were rated as either Important or Critically Important by at least 50% of faculty respon-dents.

A number of respondents added purposes of their own in an “Other” fi eld, including Decision support; Education for Keck and informatics students; Initiat-ing new studies using the same database and speci-mens if available; IRB; Patient information for labo-ratory medicine research; Physiology, mechanisms; Prospective etiologic research; Systematic reviews; Access to MRI neuroimaging images.

Purpose (Total Responses) Would NotUse It for This

Purpose

MinimallyImportant

Important CriticallyImportant

8 12 25 81

6% 10% 20% 64%

13 20 33 60

10% 16% 26% 48%

13 23 37 53

10% 18% 29% 42%

30 21 30 42

24% 17% 24% 34%

20 20 44 37

17% 17% 36% 31%

27 25 38 35

22% 20% 30% 28%

28 27 36 34

22% 22% 29% 27%

24 25 44 32

19% 20% 35% 26%

Precision/personalized medicine (125)

Health access disparities research (125)

Historical data extraction for retrospectivestudies (126)

Health outcomes research (126)

Identification of potential participants in ongoing or planned clinical trial (126)

Quality healthcare research (123)

Health effectiveness research (121)

Health economics/cost effectiveness research(125)

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CDWR types of dataUsing the same rating system, survey respondents were next asked to rate 23 diff erent types of data that could be included in a CDWR. Five data types were rated as Critically Important by at least 50% of fac-ulty: Demographics, Diagnoses, Procedures, Laboratory

test results, and Outcomes. Th e table below presents the combined number and percentage of faculty who rated each data type as either Important or Critically Important. Appendix B contains all responses to the open-ended “Other types of data” item.

Type of Data (Total Responses)

Diagnoses (ICD 9/10) (126) 116 92%

Outcomes (124) 114 92%

Demographics (125) 110 88%

Medications (126) 110 87%

Laboratory test results (124) 105 85%

Procedures (CPT) (123) 102 83%

Radiology reports (123) 95 77%

Elements of physical exam other than vitalsigns (122)

83 68%

Pathology reports (125) 84 67%

Family history (125) 84 67%

Elements of physical exam vital signs (123) 82 67%

Images (122) 80 66%

Genetic/genomic data (123) 79 64%

Smoking status (125) 77 62%

Physician notes (121) 74 61%

Bio repository data (124) 74 60%

Drug/Alcohol use (123) 73 59%

Stage (for cancer diagnoses) (123) 71 58%

Financial/cost data (122) 70 57%

Review of Systems (120) 68 57%

Other text in medical records (115) 51 44%

Insurance coverage (123) 54 44%

Allergies (125) 44 35%

Important or Critically Important

0% 25% 50% 75% 100%

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CDWR sources of dataRespondents were asked to rate the importance of having access to clinical data from the following sources: Keck Medical Center of USC, Children’s Hos-pital Los Angeles (CHLA), Los Angeles County Hos-

pital (LAC+USC), and the Los Angeles County public health system (DHS). Both Keck Medical Center and LAC+USC were rated as Critically Important by 57% of faculty respondents.

When asked, “In addition to hospital electronic medi-cal records, pharmacy records, lab data, and fi nan-cial systems, are there other sources of data that you would like to see ultimately included in the CDWR,” the majority of respondents checked Cancer Registry (63%) and Death Registry(ies) (72%). Other types of

sources provided by the respondents include Dis-ability and Social Services Registry; Chronic Disease Registry; Obesity and diabetes registry; Rehabilitation reports and data; Patient satisfaction data; Brain im-ages.

Source (Total Responses) Would notuse

MinimallyImportant


12 12 29 71

10% 10% 23% 57%

25 15 25 54

21% 13% 21% 45%

10 11 33 71

8% 9% 26% 57%

19 18 33 41

17% 16% 30% 37%

Keck Medical Center (124)

CHLA (119)

LAC+USC (125)

DHS (111)

Registry Type Number ofresponses*

% of total

Cancer Registry 55 63%Cardio Registry 30 34%Death Registry(ies) 63 72%

* Multiple selections possible

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Clinical Trials Management System

CTMS capabilitiesTh e next section of the survey pertained to a clini-cal trials management system (CTMS). Respondents were presented with six broad components or capa-bilities of a CTMS and asked to rate each in terms of its importance to their research. Patient Management and Biorepository Management received the highest

ratings from faculty (44% and 40% selected Critically Important, respectively), whereas the top two compo-nents according to staff were Patient Management and Study Management (63% each). Sixty percent of staff rated a Financial Management component as either Important or Critically Important .

Capability Respondent Type(Total Responses)

Would not use MinimallyImportant


11 21 43 48

9% 17% 35% 39%

3 5 14 38

5% 8% 23% 63%

28 26 41 28

23% 21% 33% 23%

12 12 10 27

20% 20% 16% 44%

13 20 36 55

10% 16% 29% 44%

2 6 14 38

3% 10% 23% 63%

12 24 39 48

10% 20% 32% 39%

3 3 19 34

5% 5% 32% 58%

22 17 35 50

18% 14% 28% 40%

8 5 22 27

13% 8% 35% 44%

23 19 33 46

19% 16% 27% 38%

7 5 22 25

12% 8% 37% 42%

Study Management (protocol tracking;enrollment tracking; study calendar)

Faculty (123)

Staff (60)

Financial Management (study budgeting;Medicare coverage analysis; invoicing)

Faculty (123)

Staff (61)

Patient Management (patient enrollment,identification, and randomization;scheduling; eligibility tracking; adverseevent tracking)

Faculty (124)

Staff (60)

Report and Data Management (electroniccase reports; data reporting and exporttools)

Faculty (123)

Staff (59)

Biorepository Management (specimen andresult tracking; inventory management)

Faculty (124)

Staff (62)

Importing current clinical study data frommy existing database(s)

Faculty (121)

Staff (59)

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Biorepository

Of the 127 faculty who responded to the item, “Please rate the importance to your research of having a structured biorepository,” 19 selected “Would Not

Use,” 16 selected “Minimally Important,” 44 selected “Important,” and 48 selected “Critically Important.”

85% of faculty said they would use a biorepository.

Would NotUse15%

MinimallyImportant

13%

Important35%

CriticallyImportant

38%

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Southern California Clinical and Translational Science Institute SC CTSI resources and servicesRespondents were next asked to rate existing and potential future clinical research infrastructure. Th e types of services that received the highest ratings from faculty were pilot funding; informatics consul-tations; and assistance in the design, conduct, and

management of human studies. Th e two “under con-sideration” resources or services were each rated as Important or Critically Important by the majority of respondents (Clinical research coordinator core: 66%; Participant recruitment service: 71%).

Would notuse

MinimallyImportant


6 11 23 76

5% 9% 20% 66%

17 16 30 51

15% 14% 26% 45%

8 11 32 72

7% 9% 26% 59%

9 12 32 70

7% 10% 26% 57%

9 21 45 49

7% 17% 36% 40%

11 24 42 44

9% 20% 35% 36%

17 21 44 41

14% 17% 36% 33%

15 21 49 38

12% 17% 40% 31%

14 23 49 36

11% 19% 40% 30%

17 27 43 36

14% 22% 35% 29%

24 34 41 23

20% 28% 34% 19%

27 33 38 21

23% 28% 32% 18%

22 34 48 18

18% 28% 39% 15%

18 23 36 46

15% 19% 29% 37%

11 24 45 42

9% 20% 37% 34%

RESOURCES & SERVICES (TOTAL RESPONSES)

CURR

ENT

RESO

URC

ES&

SERV

ICES

PILOT FUNDING (116)

CLINICAL RESEARCH SPACE AND SERVICES (114)

CON

SULT

ATIO

NS

Biostatistics (123)

Statistical analysis (123)

Data management (124)

Study design (121)

Bioinformatics (123)

UN

DER

CON

SIDE

RATI

ON

CLINICAL RESEARCH COORDINATOR CORE (123)

PARTICIPANT RECRUITMENT SERVICE (122)

Conducting and managing human studies(123)

Regulatory knowledge and support (122)

Translation of preclinical discoveries(123)

Scientific writing (122)

Community engaged research (119)

Research ethics (122)

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• A clinical research coordinator core would be extremely helpful for a biological / biomarker study we are trying to get off the ground. A core - which could charge for their expertise in coordinating such activities - would be a great help.

• Access to trained clinical coordinators would be extremely helpful.

• Artifi cial intelligence machine learning big data management

• Data core: Need experience and help from someone working with the data on a daily basis to assist in producing extracts and analytic data fi les.

• I don't get out enough - I could use help networking

• I have good coordinators, but it would be a very valuable resource for the institution overall.

• One-stop service to submit request for obtaining clinical data and/or biorepository specimens from USC study sites (Keck, CHLA, LAC-USC, etc)

• Really need to improve access to bioinformatics experts. Th is is a major bottleneck for our research.

• Specifi c consultation and troubleshooting on REDCAP or any improved similar data collection tools; it beats Qualtrics on most indicators but problematic still

• Th e importance of having a PARTICIPANT RECRUITMENT SERVICE cannot be over emphasized. Th is is the Achilles Heel of many studies.

• Training of graduate and post graduate young investigators in clinical translational research

SC CTSI - Other valuable resources and servicesAsking the question, “What other services or resources would be valuable to your work?” elicited a dozen responses from faculty, including more than one expressed need for trained clinical coordinators. All faculty responses are shown below.

Southern California Clinical and Translational Science Institute

“Th e importance of having a participant recruitment service cannot be over emphasized. Th is is the

Achilles Heel of many studies”

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Perceived Challenges in Conducting Clinical Research

A qualitative review of the responses to the open-end-ed question, “What is your biggest challenge in con-ducting clinical research?” revealed a number of chal-lenges perceived by the community: Administrative hurdles (mentioned by 26% of faculty respondents), Funding (24%), Access to clinical data or specimens

(21%), and Clinical research support staff (21%). Other frequent responses included Participant recruitment, Subject-specifi c expertise/assistance, and Dedicated time. Th e table below includes select responses as examples under each category; for a complete listing of responses, see Appendix E.

Administrative Hurdles 22 26% 15 52%

Funding 20 24% 4 14%

Access to Clinical Data or Specimens 18 21% 4 14%

Clinical Research Support Staff 18 21% 3 10%

Participant Recruitment 15 18% 7 24%Participant Recruitment Needs

Cohort recruitment and retention

Recruiting and sustaining non english speaking populations

Obtaining samples relevant to my studies

Getting well characterized and well preserved specimen.

Support Staff Needs

Sufficient number of competent clinical research support staff

Finding experienced research coordinators

Specimen/Sample Access

Compliance officers who don't understand human research

Non integrated Administrative Systems

The existence of so many different entities (CISO, CTSI, HRA, IRB, etc.) that have different requirements for similar things

CRO

Getting the clinical trial budgets, Medicare Coverage Analyses, and Research Order Forms from USC CRO in a timely manner.

Lack of Funding

Getting NIH funding!

Minimal start up funds available for junior faculty.

Data Access

Lack of databases to find patients with specific conditions / diagnoses

Having to review paper medical charts, electronic charts, Affinity, Synapse systems to mine data

Compliance

Faculty(84 total respondents)

Staff(29 total respondents)

# of UniqueMentions

# of UniqueMentions

% ofRespondents

% ofRespondents

IRB/Regulatory

Disorganized and disconnected systems for regulatory approvals.

IRB delays

Administrative Processing Time/Efficiency

Cumbersome paperwork submission and review processes

Con nued on p. 15

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Perceived Challenges in Conducting Clinical Research

Subject Specific Expertise/Assistance 15 18% 4 14%

Dedicated Time 12 14% 1 3%

Communication, Support, and Engagement 6 7%

Facilities and Space 5 6% 2 7%

Working Collaboratively 3 4% 3 10%

Not Categorized 4 5% 1 3%No institutional resources

Positive outcome of the studies

Team Building/Collaboration

Identifying partners

Differential capabilities and resources in interdisciplinary teams

Keeping Confidentiality in diverse groups

Facilities

Lack of a CTU in a convenient location

Getting quality microarray/Next Generation sequencing data done via a core

Space

People fight over freezer space

Clinical Research Knowledge and Engagement

Difficulties in enrolling patients into clinical trials (parental distrust of research)

Disseminating information about the study to other treating physicians and patients in the community

Departmental Support

Obtaining fresh tumor specimens with Dept. cooperation and flexibility

Securing time and money in the first place

Coordinating dissemination of multiple secondary outcome papers after the funding for the clinical trial has ended and the primary outcomes havebeen published

Mentorship

Mentorship

Funding Applications

Assistance with applying for funding

Help with protocol development and study design

Lack of time

Carving time away from my administrative demands

Publication

Biostatistics

Access to clinicians with knowledge of biostatistics and time to help

Data Management

Data management

Translational Value

Evaluating how 'translatable' mouse research is to clinical issues

Study Design

Identifying the appropriate question to be addressed in a clinical study

Faculty(84 total respondents)

Staff(29 total respondents)

# of UniqueMentions

# of UniqueMentions

% ofRespondents

% ofRespondents

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Appendix A: Full Survey

Survey TitleNew tools to enable clinical research: Clinical Data Warehouse for Research (CDWR) and Clinical Trials Management System (CTMS)

Sec on 1 of 5: Par cipant Informa on1. First & Last Name: [free text]

2. Title: [drop-down]ProfessorAssociate ProfessorAssistant ProfessorStaff Other (please specify) [free text]

3. Highest Degree: [drop-down]MDPhD PharmDDDSDOMSWRNMBADOTDPTMPHMS BSOther (please specify) [free text]

4. Email address: [free text]

5. Campus where you spend the majority of your me: [drop-down]University Park CampusHealth Sciences CampusChildren’s Hospital Los AngelesBoth USC and Children’s Hospital Los Angeles Other (please specify) [free text]

6. School and Department/Division: [drop-down] Den stry

Biokinesiology and Physical Therapy Biomedical SciencesCraniofacial Molecular BiologyDental Public Health and Pediatric Den stryEndodon cs, Oral and Maxillofacial Surgery and Orthodon csOccupa onal Science and Occupa onal Therapy

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Periodontology, Diagnos c Services and Dental HygieneRestora ve SciencesOther

Engineering Biomedical EngineeringOther

Gerontology Medicine

AnesthesiologyBiochemistry and Molecular BiologyCell and NeurobiologyDermatologyEmergency MedicineFamily MedicineMedicineMolecular Microbiology and ImmunologyNeurological SurgeryNeurologyObstetrics/GynecologyOphthalmologyOrthopaedic SurgeryOtolaryngology – Head & Neck SurgeryPathologyPediatricsPhysiology and BiophysicsPreven ve MedicinePsychiatry and Behavioral SciencesRadia on OncologyRadiologySurgeryUrologyOther

Pharmacy Clinical Pharmacy and Pharmaceu cal Economics and PolicyPharmacology and Pharmaceu cal SciencesOther

Public Policy Social Work Other (please specify) [free text]

7. Are you affi liated with the USC Norris Comprehensive Cancer Center? [radio bu ons]Yes /No

8. What is your role and primary ac vity(ies)? Faculty

Clinician researcher (>15% spent on research)Clinical researchClinical trialsHuman mechanis c research (including “-omics”)Cancer research

Appendix A: Full Survey (cont’d.)

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Health outcomes/servicesPreven on researchBehavioral researchEpidemiology (including gene cs and epidemiology)Other (please specify) [free text]

Clinician (0-15% spent on research) Transla onal researcher (early stage development)

Drug developmentDevise developmentOther

Basic researcherStaff

Clinical research support Study coordinator Informa on scienceProgram managerFinanceOther research support (please specify) [free text]

Other (please specify) [free text]Other (please specify) [free text]

Sec on 2 of 5: Clinical Data Warehouse for Research (CDWR)The ques ons in this sec on pertain to the Clinical Data Warehouse for Research (CDWR). There is signifi cant interest in the crea on of a clinical data warehouse for use by researchers across the USC enterprise. Containing pa ent data from USC hospitals, Children’s Hospital Los Angeles (CHLA), and ul mately Los Angeles County (LAC), the warehouse would support the research enterprise by enabling large-scale popula on analysis and aggregate data output, as well as cohort iden fi ca on and other eff orts.

9. For what purpose(s) would you use a clinical data warehouse? Please rate each of the following in terms of its importance to your research. [radio bu ons]0 = Would not use it for this purpose; 1 = Minimally important; 2 = Important; 3 = Cri cally important/essen al

Iden fi ca on of poten al par cipants in on-going or planned clinical trialHistorical data extrac on for retrospec ve studiesHealth outcomes researchHealth access dispari es researchPrecision/personalized medicineHealth eff ec veness researchHealth economics/cost eff ec veness researchQuality healthcare researchOther (please specify) [free text]

10. Listed below are types of data that could be included in a CDWR.Please rate each of the following in terms of its importance to your research. [matrix]0 = Would not use it for this purpose; 1 = Minimally important; 2 = Important; 3 = Cri cally important/essen al


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DemographicsDiagnoses (ICD 9/10)Procedures (CPT)Medica onsLaboratory test resultsRadiology reportsStage (for cancer diagnoses)Pathology reportsOutcomesFinancial/cost dataInsurance coverageBio-repository dataGene c/genomic dataElements of physical exam – vital signsElements of physical exam – other than vital signsReview of Systems (i.e., a checklist covering the organ systems)AllergiesSmoking statusDrug/Alcohol useFamily historyImagesPhysician notesOther text in medical recordsOther data type (please specify) [free text]

11. In addi on to hospital electronic medical records, pharmacy records, lab data, and fi nancial systems, are there other sources of data that you would like to see ul mately included in the CDWR? (Check all that apply) [check box]

Cancer RegistryCardio RegistryDeath Registry(ies)Other (please specify) [free text]

12. Please rate the importance to your research of having access to clinical data from the following loca ons. [radio bu ons] 0 = Would not use; 1 = Minimally important; 2 = Important; 3 = Cri cally important/essen al

Keck Medical Center of USCChildren’s Hospital Los AngelesLA County Hospital (LAC+USC)LA County public health system (DHS)

13. Please rate the importance to your research of having a structured biorepository. [radio bu ons]0 = Would not use; 1 = Minimally important; 2 = Important; 3 = Cri cally important/essen al

14. Please provide any other feedback/concerns you may have related to the CDWR. [free text]


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Sec on 3 of 5: Clinical Trials Management System (CTMS)The following ques ons pertain to the development of a Clinical Trials Management System (CTMS).

15. Please rate each of the following capabili es of a CTMS in terms of its importance to your research. [radio bu ons]

0 = Would not use; 1 = Minimally important; 2 = Important; 3 = Cri cally important/essen al

Study Management (protocol tracking; enrollment tracking; study calendar)Financial Management (study budge ng; Medicare coverage analysis; invoicing)Pa ent Management (pa ent enrollment, iden fi ca on, and randomiza on; scheduling; eligibility tracking; adverse event tracking)Report and Data Management (electronic case reports; data repor ng and export tools)Biorepository Management (specimen and result tracking; inventory management)Impor ng current clinical study data from my exis ng database(s)Other (please specify) [free text]

16. Please provide any other feedback/concerns you may have related to the development and implementa on of a CTMS. [free text]

Sec on 4 of 5: Addi onal par cipa on in planning process17. We will soon begin selec ng individuals to guide the development of the CDWR. We want broad

representa on of perspec ves and research areas. Would you be interested in par cipa ng in: (check all that apply) [check box]

a. Quarterly mee ngs intended to update and gather input from a broad range of users on the development and implementa on of the CDWR?

b. A working group that met more frequently (e.g., monthly) to develop key func onality, policies or opera onal strategies for the CDWR?

18. We will soon begin selec ng individuals to guide the development of the CTMS. We want broad representa on of perspec ves and research areas (faculty and staff ). Would you be interested in: (check all that apply) [check box]

a. A ending two CTMS vendor demonstra ons and rate their func onality, ease of use, etc., on the a ernoons of May 13th and May 29th on the HSC campus?

b. Par cipa ng on an advisory commi ee regarding development/implementa on and policy development for a CTMS (mee ng every 6 to 8 weeks or via email ques ons)?

c. Serving on a working group that meets more frequently (e.g., monthly) to develop opera onal strategies for the CTMS?

Sec on 5 of 5: Exis ng and poten al clinical and transla onal research infrastructureThe Southern California Clinical and Transla onal Science Ins tute (SC CTSI) is focused on serving researchers and would like to be er understand your current needs.

19. Please rate the following currently available resources/services, in terms of importance to your research. [radio bu ons]0 = Would not use; 1 = Minimally important; 2 = Important; 3 = Cri cally important/essen al


www.sc-ctsi.org |

Pilot Funding: to support research, career development, innova ve technologies and methodologies, progression of discoveries and mul disciplinary team forma onClinical Research Space and Services: two clinical sites; outpa ent and inpa ent clinical research space; access to trained clinical research staff ; sample procurement; specimen processing and handling laboratory; neurologic and bionutri on evalua ons; and more Consulta on Services: Research advice from faculty, senior staff and external consultants

Study DesignRegulatory Knowledge and SupportResearch EthicsConduc ng and Managing Human StudiesData ManagementBioinforma csBiosta s csSta s cal AnalysisScien fi c Wri ng Transla on of preclinical discoveries Community-engaged Research

20. Please rate the following under considera on resources/services. [radio bu ons]0 = Would not use; 1 = Minimally important; 2 = Important; 3 = Cri cally important/essen al

Par cipant Recruitment Service: Exper se, tools and resources to recruit par cipants for studiesClinical Research Coordinator Core: Trained coordinators available on an ad hoc recharge basis

21. What other services or resources would be valuable to your work? [free text]

22. What is your biggest challenge(s) in conduc ng clinical research? [free text]


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Appendix B: CDWR – Other Types of Data

Faculty responses to “Other data type [that could be included in a CDWR]”:

• adverse events, provider type (dept, service), guideline use• behavioral health history• Digital static, dynamic, and video Histopathology and cytopathology whole slide images• Emergency department visits, Hospitalizations• followup• For personalized “omics” and tranlational studies the quality of specimens collected and saved,clincal

stages of the disease and response to thearapy data are critical.• If waveforms for vital signs and hemodynamic variables were available• Interventions (intubation, inotropes, CPR, etc.)• language• Medical errors, Medical malpractice claims that resulted• Medical images, surgical history• medical service use, unit in hospital, advance directive status and content, palliative care consultation• outside referral records• Plasma and CSF samples• pregnancy and birth data• prescribed and implanted medical devices• prescriptions; evidence of adherence; recommendations for devices; use of technology; role groups en-

gaged with patient; number of contacts for specifi ed clinical problems; note this list is written for MDs, we need all disciplines including patients engaged in building such a data warehouse

• Primary care physician• Rehabilitation utilization and daily documentation• reproductive history• samples and data of healthy potential matched controls• signs and symptoms• socioeconomic status; marital status; a brief clinical survey about health behaviors (e.g., physical ac-

tivities); residential addresses• surgical reports, biorepository of cultured organisms• Th e kind of data that would be relevant for many rehabilitation trials is not refl ected above. Th is data-

base seems as if it would largely serve the needs of those interested in pharmacological issues.• tumor biology features (estrogen receptor, progesterone receptor, HER2)• what treatment they received and for how long

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Appendix C: CDWR – Other Feedback and Concerns

Faculty responses to “Please provide any other feedback/concerns you may have related to the development and implementation of a CDWR”:

• Would be hugely helpful but as a Division Chief for many of my faculty, essential to advancing us as an academic medical center.

• Data must be stored in an abstract able/searchable format 2. Must be integrated to clinical work-load so as to prevent duplication 3. Who owns the data?

• Adequate support for the infrastructure is critical. In my experience, it cannot be dependent on indi-vidual investigator’s grant support/chargebacks. Th is is a capital investement in our future as a research institution.

• As near real time as possible• Need a transdisciplinary focus, engage patients and all providers in building key elements; recall for

pharmacy: too oft en data bases track what was dispensed or prescribed and no data on patient use of drugs including nursing notes and data on prescription refi lls

• Biorepository needs to be clinically annotated. Infrastructure needs to be established for tumor bank-ing and adequate communication with operating surgeons/research coordinators and pathology. Th e department of pathology and department of surgery members who participate in tumor banking should receive credit as co-authors on manuscripts resulting from their eff orts.

• Biorepository should if possible have bloods at various stages of disease for biomarker discovery.• Development of a useful and accessible database is critical to my research. Diffi culty in getting this

information has the primary roadblock in getting research completed.• I know from experience that absorbing free text could pose HIPAA issues - it is more diffi cult to mask.

If we had an identifi er that lets us track back to MR where necessary, that might help.• I would be happy to help develop data structure for assessment of family structure and history, and

history of exposure to selected agents• Key is connecting the LAC+USC patient data & the UH/Norris patient data.• Please see earlier note. While I’m sure this database will mee the needs of those interested in pharma-

cological and medical interventions, it will may not fully support rehabilitation eff orts as currently designed.

• something that is critically needed, however there are other registries for a variety of specialties, so one challenge is to integrate the data capture for this database with already exisiting databases.

• We are particularly interested in the sustainability of changes obtained during hospitalization and as such are interested in follow-up status data.

• Working on clinical samples has been abasic problem because “birepositories” are personal! No shar-ing unless there is a personal interest.

• would be excellent to link this directly to the EMR and make the EMRs able to communicate across campuses.

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Appendix C: CDWR – Other Feedback and Concerns (cont’d)

• Would be great to have a clinical data warehouse that is linked anonymously to biorepository of pa-tient specimens

• Would suggest periodic update of the patient information so patient information can be followed lon-gitudinally

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Appendix D: CTMS – Other Feedback and Concerns

Responses to “Please provide any other feedback/concerns you may have related to the development and implementation of a CTMS”:

Faculty• Cafe and Redcap are working well• Need to have it operative at County as well as USC. Also, would be great if it alerted when protocol

patient showed up for a regular health system visit.• Please arrange focus groups and other feedback opportunities aft er this survey is completed• Would like integration of the biorepository clinical data to be linked to clinical trial data so outcomes

can be analyzed based on genomic and other biomarkers• Would love for this to ultimately communicate with other data repositories and large databases. Th e

ability to import data from large databases into this would be phenomenal.• Would need to be able to access from my LAC offi ce computer; archives from paper medical records

Staff and Other• Better still is if the electronic case reports, data reports can self-populate from the hospital systems• Concern if the study specifi c trial has it specifi c tracking logs then having to enter the same informa-

tion into the CTMS system? Or would the CTMS be used if the trial did not have these systems are in place.

• Development of the management systems is theoretically a good idea, however, general systems are oft en not setup to individual project needs

• Having a fair, easy to use system to access clinical samples (i.e., one PI can’t keep all the samples!)• It will hopefully be more intuitive and user-friendly than TRUE 2.0.• Th e system should ideally accommodate, be useful to, various types of research and disciplines

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Appendix E: All Perceived Challenges

All responses to “What is your biggest challenge(s) in conducting clinical research?” by category:

Access to Clinical Data or SpecimensData AccessAbsence of centralized resources, data and procedures, making start-up extremely taxingAccess to aff ordable blood draws and tissues biopsies in human researchaccess to dataAccess to Electronic Medical Records data for CTMSHaving to review paper medical charts, eletronic charts, Affi nity, Synapse systems to mine dataLack of access to patient clinical data and diffi culty in identifying eligible patients for retrospective radiology studiesLack of data collectionLack of databases to fi nd patients with specifi c conditions / diagnoseslack of infrastructure to access large patient dataset and biospecimenslinking biospecimens to clinical dataNo central database no source of clinical data the lack of a searchable medical records for study recruitmentWe need a database and the associated support to extract information from the existing patients population to form and test hypothesis, and to develop prospective clinical studiesSpecimen/Sample AccessCollection of specimens Getting well characterized and well preserved specimen. We need a”CORE” for preserving quality contrrolled specimens that can be used for many diff erent tests in the future. Th e core should save not only the specimen slides or paraffi n blocks but also RNA, DNA and protein if material is available for future omics studies.If fresh material is available then tissue should be cultured for short term and preservrd in small aliquots for researchhaving access to tissue lack of infrastructure to access large patient dataset and biospecimensLack of resources available (no system for creating a tissue repository)-every lab does it diff erently Obtaining fresh tumor specimens with Dept. Pathology cooperation and fl exibilityobtaining samples relevant to my studiesTh e Tissue Procurement Core as it is currently being run is my biggest challenge. Administrative HurdlesAdministrative Processing Time/Effi ciencyCernercumbersome paperwork submission and review processesEffi cient start-up including development of the CRFs, database, and recruitment infrastructurePaperwork

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the most challenging issue is the bureaucracy that county has. the lab agreement takes a long too long to approve, then aft er that to pull the slides and blocks more and more time. very ineffi cient, they lead you to despair. I hope there is another way to cut the time and rush things throughthe USC bureaucracy and paperwork, the process needs to be streamlined, and much mor effi cient if we are going to compete for clinical research grants with other established institutionsTIME- Gathering so much info to put a patient on study or waiting for data that you need to enter from and off site slows down the process and you now have others waiting on you for what your waiting onToo much administrative paperwork and requirements to be met - EVERYBODY has more and more from C and G to fi nancial systems, to Research Admin!working with grants and contracts: now that the system will be changing and will the new staff be able to decrease the turn around time of executing contracts and assisting with working witht the research team to build and provide a budgetComplianceCompliance is not helpful with executing contracts or confi dentiality agreements. Compliancecompliance offi cers who don’t understand human researchCROAlso approval from CRO (approx 3-6 months) for a research order form is too long and hinders research. We’ve had student research delayed because they did not receive necessary approval from CRO, despite frequent follow-up. For Industry Sponsored clinical trials, the amount of time it takes to negotiate and fi nalize an agreement has discourage my faculty from working with industry sponsorsGetting the clinical trial budgets, Medicare Coverage Analyses, and Research Order Forms from USC CRO in a timely manner.Getting the MCA, budget & Research Order Form for non-industry sponsored trialslack of infrastructure for performing clinical trialsTimely sponsor contract negotiation and approval, MCA, and budget negotiation and approvalUnhelpful and procrastinating CRO; ineff ective, slow contract negotiationIRB/RegulatoryGetting anything through the IRB process. It takes FOREVER! getting studies approved by IRBHaving a structured system and adequate personnel in ensuring that the regulatory group is able to do their tasks accurately and in a timely mannerInitial regulatory hurdles before a study is openedIRB delays and infl exibilityObtaining regulatory approvalRegulatory environmentthen all disorganized and disconnected systems for regulatory approvals. We need ONE portal through which reserachers and thier teams can access all aspects of tools and retulatory applications for clinical researchworking through the IRB processwriting IRBNon-integrated Administrative SystemsA website with guidance (contact info, necessary forms, etc) would be helpful.

Appendix E: All Perceived Challenges (cont’d.)

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Coordinating eff orts/reports/applications across disciplines and schoolthe bureaucratic nightmare that is USC. As a coordinator there are over a dozen diff erent USC departments that I need to go through in order to set up new studies and have proper training/clearance/access to information. Th is is especially true with regards to budgeting and contractingTh e existence of so many diff erent entities (CISO, CTSI, HRA, IRB, etc.) that have diff erent requirements for similar things--for example, I had to take 2 HIPAA courses that were almost identical when I fi rst started working here. Th e offi ce of compliance didn’t recognize the one that was on the IRB website. Th e roles (of all of the diff erent departments) get confusing.Th e very limited central infrastructure at USC for research. Unfortunately, what little infrastructure that is available in our system is set up for departmental research and not programmatic researchthen all disorganized and disconnected systems for regulatory approvals. We need ONE portal through which reserachers and thier teams can access all aspects of tools and retulatory applications for clinical researchtoo many systemsWorking within diff erent departments to coordinate scheduling of patient proceduresClinical Research Support Staff A clinical research coordinator core would be exxtremely helpful for a biological / biomarker study we are trying to get off the ground. Our clinical trials offi ce has indicated they are too busy to obtain consents and accrue samples, but at the same time it would not be appropriate for lab researchers to obtain consents and samples. A core - which could charge for their expertise in coordinating such activities - woudl be a great helpAbsence of centralized resources, data and procedures, making start-up extremely taxingAccess to resources to perform the researchadminister pharmacological manipulations As Research Administrator, assisting faculty with determining who the appropriate contacts are to have blood work or radiology work doneavailable research assistantscoordinating all study personnel, as a Ph. D. researcher this is challengingCoordinating eff orts/reports/applications across disciplines and schoolFinding experienced research coordinatorslack of mid-level support so that faculty can concentrate on academic endeavorslack of support staff Not having enough regulatory staff to do the workOverworked research coordinators person to mine the dataproject managersqualifi ed staff to conduct specifi c tests within in budget limits, (e.g. treadmill, dexa) management and analysis of blood assays scheduling CTU visitsskilled research assistantsStudy coordinator or research nursesuffi cient number of competent clinical research support staff Support staff


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Communication, Support, and EngagementClinical Research Knowledge and Engagementdiffi culties in enrolling patients into clinical trials (parental distrust of research), Disseminating information about the study to other treating physicians and patients in the communitygetting MDs to comprehend clinical studies and getting their approval for pt participationlack of knowledge on the part of departments when they want to be supportiveDepartmental Supportlack of department supportObtaining fresh tumor specimens with Dept. Pathology cooperation and fl exibilityDedicated TimeCarving time away from my administrative demandsfi nding adequate time given clinical care obligationsHaving dedicated research time away from my clinical dutiesprotected timeSecuring time and funding in the fi rst placetimetime time away from clinical responsibilitiesTime from clinical responsibilitiesTime!Trite but true: time and moneyFacilities/SpaceFacilitiesadequate user and patient friendly facilitieslack of a CTU in a convenient locationwe need more clinical research facilities Sample Processing CoreGetting quality microarray/Next Generation sequencing data done via a core and analyzed via our bioinformatician.Spacelaboratory spacepeople fi ght over freezer space spaceFunding$$$Access to aff ordable blood draws and tissues biopsies in human researchadequate fundingAssistance with applying for fundingFunding


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funding, decrease NIH fundingFunding. Much of the funding available through major funding agencies is less likely to be directed towards rehabilitation clinical trialsfundsGetting NIH funding!inexperience with defi ning and framing clinical research questions and how to get pilot funding to pursueLack of suffi cient funding from federally supported trialsminimal start up funds available for junior faculty.Obtaining fundingsecuring fundingSecuring time and funding in the fi rst placeTrite but true: time and moneyNot CategorizedI currently perform basic with translational outlook research onlyLack of infrastructure supportNo institutional resourcesPositive out come of the study’sREDCAP type toolsParticipant RecruitmentAcquiring subjectsCohort recruitment and retentionEffi cient start-up including development of the CRFs, database, and recruitment infrastructureFollow-up attritionHaving access to patients to get clinical samplesinform consentknowing how to recruit and consent patientsLack of resources to streamline pre-screening for subjectsparticipant recruitmentPatient accrualPatient Recruitmentpatientsrecruiting and sustaining non-english speaking populationsrecruiting subjects recruitmentRecruitment and retentionrecruitment and retention of study participantsRecruitment of Patients Th e cancer registry has numerous wrong numbers and unable to locate patients using other resources


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Th e importance of having a PARTICIPANT RECRUITMENT SERVICE cannot be over emphasized. Th is is the Achilles Heel of many studiesunderstaffi ng for participant recruitment and follow-upSubject-Specifi c Expertise/AssistanceBiostatisticsaccess to clinicians with knowledge of biostatistics and time to helpanalysisAs a new researcher, help with protocol development and study design; statisticsGetting quality microarray/Next Generation sequencing data done via a core and analyzed via our bioinformatician.management and analysis of blood assays - currently using Quest and would like to keep it in-house if cost eff ectivestatistical supportData Managementdata managementData Management We need a database and the associated support to extract information from the existing patients population to form and test hypothesis, and to develop prospective clinical studiesFunding ApplicationsAssistance with applying for fundingInitiating StudiesIdentifying the appropriate question to be addressed in a clinical studyinexperience with defi ning and framing clinical research questions and how to get pilot funding to pursueMentorshipmentorshipProtocol DevelopmentAs a new researcher, help with protocol development and study design; statisticsPublicationCoordinating dissemination of multiple secondary outcome papers aft er the funding for the clinical trial has ended and the primary outcomes have been publishedStudy DesignAs a new researcher, help with protocol development and study design; statisticsTranslational ValueEvaluating how ‘translatable’ mouse research is to clinical issuesKnowing how to move from a basic discovery to translational studyWorking CollaborativelyMatching ServiceIn my particular case I am in a situation where as an Biomedical Engineer I need to work in conjunction with a clinician. It would be helpful to have a matching service, where technical experts can work with clinical experts to work on issues and projects.


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Diff erential capabilities and resources in interdisciplinary teams. Example: citation soft ware saves valuable time, can we get equal access to EndNote and RefWorks and easy transfer of fi les? Referencing should not be a burden in building a grant application given these resources. Make sure that all researchers know of new ORGANIZATION option on Blackboard for posting materials, sharing announcements, draft s etc. Experts should explore and coach on use of Discussion board to short circuit asynchronous emails.facilitating collaborationforming a multidisciplinary teamIdentifying partnersMy area of research is based on addiction. We do not have a strong addiction clinical group at USC. Currently collaborating with UCLAKeeping Confi dentiality in diverse groups


Assessing Clinical Research Infrastructure Needs

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