REGIONAL EXPERTISE IN A GLOBAL MARKET

Time to Roll up our Sleeves and Focus on

Solutions and Strategies to Get Past Living in Hope on Enrollment

Dan DiazVice President, Global Business Development215-348-3543

Is the Trial Balloon Rising?

Overview

19 years in the CRO/SMO space has provided a

perspective on how companies attack enrollment

solutions

Observation from conferences and from meetings with

sponsors, sites and vendors has shown that the standards

are still the same

SPRI founded in 1972 as a Clinical Site

Leading to our site strategies for achieving enrollment

Focused on being different in our approach

Setting the course for identifying new tools and

expertise

10th anniversary as a Specialty CRO

The Focus for Today

We are calling this a “WORKSHOP” Time to roll up our sleeves

Share Ways that Work- for your projects

Find out what “We haven’t done before”

Explore some of these tools Informed Consent Revisions

Patient and Physician Outreach

Community Intervention/Patient Advocacy Utilization

National Enrollment campaigns

Point of Care information

Patient Advocacy Campaigns

Patient Education

Discuss “Why it did not work”

OK- Let‘s Set the Baseline Where are we from?

Community Centers in Hospitals

Academic/ Private/ Group

Sponsor/Biotech/Pharma

What percent of your office physicians participate in

trials? Do you have a patient advocate for clinical studies?

Does the Hospital have one?

For the Pharma’s/CROs - do you support payment for

advocates/ clinical trial materials/ publications at the

site level for Oncology Trials?

How do you work that into your budget?

Do you expect the CRO to put that in their budget

upfront?

If no, does your company do this for other indications?

Time to Roll up our Sleeves

Our goal is not to debate but Share Ideas

• Get a pen • Get your texting

ready• We are asking for

your feedback

Questions write or text answers to 913-706 9052

1. What 3 Ways does My group approach patients? physician level, Nurse level, Institution level

2. What are the top 3 ways your institution educates your patients/families on clinical trials?

3. List 3 “other methods” you haven’t tried but have interest in learning

4. What 3 cancer types are “easy for your clinic to enroll?” 5. What 3 types are harder? 6. What percent are Supportive Care trials?7. Question for the group- Do we share that information with other

cancer centers in the area?

8. Why is your site selected for XX indication?

9. What are the top reasons why you are not chosen?

10. What are you willing to do to change?

Pens and Phones Down Time

The Frustration Within Oncology Trials

8% of US Based Oncology trials enroll on time Only 1-3% of US patients with Cancer participate in clinical

trials Drug development delays within the trials are leading to many

company’s financial strife

Hesitation to try new things runs rampant Reluctance to build in strategies upfront is Sponsors dilemma

Have you ever heard the following? “It is always the CRO’s Fault” The sites aren’t meeting their enrollment projections”

So what are we doing to be successful?

What is helping us overcome these situations?

What has made us successful?

The Living in Hope Method- The CRO Here’s a list of methods that CROs always talk and write about…

Beware- Living In Hope and Running Studies the way they always have Pod Calls, 1 hour per week site management Study Coordinator Calls Send Candy Standard Feasibility to their Database of Sites

“Feasibility sent to 100 sites…” Do they really know them? Do they have a Freezer? They don’t ask- “How often do you use XXX on your patients with YYY cancer

IF XXX is not readily used- SOC in that center- would they enroll patients in that trial? Not usually

If they are a $1 B CRO, and 35 % of their studies are Oncology, and only 20% of the subjects are getting enrolled in the US, how’s their database?

Potential Strategy- Don’t add more sites- add countries 6-8 month start up in an academic site is longer than time in Georgia/Poland/Belarus

Some countries you can be up and going in less than 3-4 months (even in oncology)

Clinical Trials Landscape

Retention

Recruitment

Awareness

CISCRP

Can’t run trials your Mother’s Way

Patient Feedback- An Interview Patient diagnosed with Thyroid Cancer in 1999

– Just enrolled in his second clinical trial.

Reason for Participation First trial- Doctor did not like prognosis after relapse and surgery

To be cured or be cured enough to go on and be in a position to be cured later on

How did he find out about Clinical Trials in Oncology He was NOT approached about studies in 1999 when he was first diagnosed

Not until relapse -and more surgery in 2007 was he approached about trials by his Oncologist in Nebraska

Found a trial in St. Louis and he flew back and forth for 6 years

PEARL- the local site performed all labs, x-rays, procedures

St. Louis Site performed all dosing (second study is still set up the traditional way)

None of his travel costs or mileage were covered by the sponsor

Since 2007 I was told that he was in a pharma study using Sutent I was upset that the sponsor did not reimburse his travel costs

It was then found out that it was a study sponsored by NCI

Why I was happy- they kept him on study (challenged assessment of PFS- board agreed)

Outcome- Longest Living Survivor

Patient Feedback Progression finally led to ending study Question- Why wasn’t he informed about trials during initial diagnosis?

His feeling was that “we” the industry only wanted to get patients who had no chance of cure and were really in bad shape.

What else did I learn? Informed Consent and Education Material Asked- between 1-10 what was his understanding of the IC

Answer 4- he did not really understand what was expected, covered and his requirements

2nd study- What was your understanding of the IC

He called it a disclosure and said that it was much clearer and easier to understand

He said he rated it between a “5-6” for his understanding

I asked him “why he felt that way” and he said he was a “lay person” and did not have the training

Here’s the Rub- He has a Masters degree and is a Lawyer

He had a hard time explaining what he was to do and had to overcome being scared to participate- Friends and Family- at first thought he should NOT participate

Patient Suggestions for Investigators and other Patients

He said that some of the Patients that he talks to Say they felt pushed to get involved in Placebo Controlled Studies (Pharma Sponsored?)

He said that he did not want a Double-Blind study as he wanted to be Cured or to be good enough to get to the next therapy that could cure him”

Suggested that “we”- Doctors offices” inform and train patients to ask questions

“Be Willing to offend the Doctor”

Be willing to ask tough questions- why would/would not have me enroll in a trial?

Why did you not tell me of clinical trials?

What is the compensation for the clinical trials? Am I a Guinea Pig?

Get Materials in the hands of the patients- before they are Diagnosed

My Take as an industry, we need information on clinical trials, in every office, our websites

He recommended magazines to be available He Knew “Cancer Today” and “CUREMagazine.com”-

recommended- as CureMagazine was easy to understand

Change CC.Gov It is too difficult to understand- He found the second study himself!

Most Importantly – Help the Patients Set Goals

John’s Initial Goals

• See his oldest boy Graduate High School- • He’s a Sophomore in College

New Goal• See his Youngest graduate High School

• Be A Grandfather • AFTER they graduate college

• “My goal is to be cured, or be good enough to make it to when a cure is found and available!”

• What goal to you have for “My Industry”

• Educate us before we get sick and need you

REGIONAL EXPERTISE IN A GLOBAL MARKET

So Let’s Get Busy!

Strategies and Solutions

You saw the data on the Patient’s Understanding

Let’s set the baseline

• How many of you write your own Informed Consents?

• Who writes those for you?

• How many of you Accept and use the Sponsor/CROs?

• How many of you have used Color?– Pictures

– Charts

– Imbedded objects?

– Patient Information Materials (in addition)

• Was it a Pharma/Bio sponsor or a Government Sponsored Trial?

• Do you believe that the real concern to not use these is the legal

risk?

Pie charts of patients receiving a patient information form (top pie, n = 365) and their decision to sign an informed consent form (second pie), their eligibility after signing (third pie), and their final ability to start in a specific phase I trial (bottom pie).

van der Biessen D A et al. The Oncologist 2013;18:323-329

http://theoncologist.alphamedpress.org/content/18/3/323.full

Informed Consent That Truly Informs

A study of clinical trial Informed Consent Forms (ICFs) found that

about 90% of ICFs are written at an 11th-grade level or higher. That

level is far too high because:

In the United States alone, more than 90 million people have

difficulty reading

1 out of 5 Americans reads at or below the 5th grade level

The average American reads at an 8th-grade level or below

Approximately 8 million US seniors have below-basic

literacy skills

Literacy levels are even lower in many of the

countries where clinical trials are often conducted

A Knight’s Tale (10th Grade Level)

Whilom, as olde stories tellen us, Ther was a duc that highte theseus; Of atthenes he was lord and governour, And in his tyme swich a conquerour, That gretter was ther noon under the sonne. Ful many a riche contree hadde he wonne; What with his wysdom and his chivalrie, He conquered al the regne of femenye, That whilom was ycleped scithia, And weddede the queene ypolita, And broghte hire hoom with hym in his contree With muchel glorie and greet solempnytee, And eek hir yonge suster emelye.

Yes, this is from the real book

22

Let Me Make it Easy (6th Grade Level)

• Theseus was the governor of Athens• He took over many countries• When he conquered Scythia he married

the queen, Hippolyta• He brought Hippolyta and her sister

Emily back to his country• There was a great celebration

Now I understand 23

New Informed Consent Suggestions

Lower the reading level to a 6th grade level

Reduce/replace legal and medical jargon-

Develop Patient Resource Guides-if IC is already approved

Use plain language

Include phonetic pronunciation (pro-nun-see-A-shun) guides Pra-STATE not Prostrate - Patients “feel better” when they pronounce it correctly

Add pictures, icons and other visual elements

Take home “booklets” of the Informed Consent

Use more white space

Provide patients with clear, easy-to-follow schedules and calendar

Work with Medical Writing groups- education agencies who perform

this.

This isn’t normal standards for CROs

Patient Education

Top Sources for Clinical Research Information

Upfront Patient Education- Question for Sponsors and CROs

When you go to the site- look for Waiting Room information on

participation in clinical trials

Provide hand out information and call center information on

cancer within indications and advise them to go to “Pro-Clinical

Study” websites and organizations

Patient Resource Guides

Branded Materials- take-home kits

Provide material to local non-profit chapters

Provide them with a list of sites and information on clinical

trials

Patient Education/Retention Materials

Broadcast media, including television, radio and newspaper

Direct mail to targeted demographics

Recruitment website

Search engine optimization for disease-state searches

Social media posts

Healthcare professional office materials, including easels, brochures, posters and

study overview and eligibility requirement handouts

“If you can make something easier, more convenient, more straightforward and

easier to understand, patients will improve their level of compliance,” John Yates, MD, executive director of clinical research at Merck Research Laboratories.

Shelton D. Patients in clinical trials don’t always follow the program.

American Medical News.

http://www.southjersey.com/articles/?articleID=2171. Accessed March

28, 2013.

Clinical Trial Solutions

Web-Based

Web keys for quick web access-even for kids

Websites that guide the patient/family member to the right resources

Outbound recruitment

Telephone scripts Newspaper ads Radio scripts

Informed Consent

Patient guide to informed consent

In-Office recruitment

Nurse inclusion/exclusion criteria Educational wall charts Patient brochures

Patient Resources

Appointment reminders Post cards; magnets

Health-literate trial education

Patient Information (study specific)

Sponsors Should Take the lead on thisMid size/larger have the Medical Education teams.

CROs don’t usually put this in the budget as it “makes their costs higher than the competition and

THEY aren’t asked for these types of solutions

For what percent of your studies do the sponsors provide these types of

materials?

Clinical Trial Integrated Services

Patient web-keys for quick access

to the global websiteAnd Study Information

Interactive educationalwebsite

Recruitment materials in a box

Peer-to-Peer Education

How many times have you had MD to MD training or Discussions

from CRO or Sponsor?

In-Office HCP-Facilitated Education

Whether for Study or Condition- Do you find these Helpful?

Patient Engagement and Retention Strategies

So where are we with Technology

Technology tools

Use new Survey technology and search electronic databases for

patient information

Survey technology saves time and money and provides better

data in faster time

Site Portals –being used for increased communication

Use the Web for patient recruitment including

Texting, web, adverts on Pinterest, Non-profit orgs

Open up for Skype and video calls

Community Tools- Shared experience and success

Enrollment methods- Yes even in oncology

Pinterest, patient/patient, community outreach, Facebook, Website

Pinterest

Mobile is only for teenagers, It only works in the US- FICTION

39

122- Number of mobile-cellular subscriptions per 100 Developed World inhabitants (ITU 2011)

40

UK-based study –Texting• www.linkedin.com/pub/joann-miller/2/22/844

95%

18%

0% 20% 40% 60% 80% 100%

Text

Phone

“No Show” rate for people who received SMS reminders was over 20% lower than those who

received phone reminder

How many of you use this method?

Study subjects had a strong preference to receive visit reminders by text over phone.

Faster Site Selection and Process

Geographical Location

Patient Population

Staff Credentials

Facilities

PAST HISTORY

Recruitment

Responsiveness

Feasibility

Create meaningful questions Survey & CDA – automate! Tracking – automate! SEV – when needed Selection recommendations

In Summary

Do not live in hope -Enrollment Just Doesn’t Happen If you are doing things the same way and they haven’t worked do

something different Redo the IC- Can your Family understand the IC? Test it! Use CROs and 3rd Parties to develop these Tools it will develop a strong

call-to-action message Engage the investigator through a new, unique way of discussing the

disease and clinical trial opportunities Use new Technologies as it helps patients with adherence and

compliance Empower investigators to educate patients

their own way (customizable) Track how the patients have found out about your studies. If they found you- great- but you should be finding them

Thank you to my contributors

Dan Chupka  Infinata, Inc.dchupka@infinata.com781-762-9158www.biopharmclinical.com

Brian S. Schaechter973-727-3768bschaechter@artcrafthealthed.comwww.artcrafthealthed.com

ddiaz@spriclinicaltrials.com www.spriclinicaltrials.com

Susan MH LewenzLitéra AxxiTRIALS+1(336)375-29x142 SLewenz@Litera.com

Medikidz USA

716-597-9073