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DMC Qualification, Composition and Training

Jane Perlmutter, PhD Patient Advocate

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Disclaimer

DMC Membership

Typical Makeup and Composition Member Qualifications Identification of DMC Members Developing the Next Generation of DMC Members

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DMC Membership

Typical Makeup and Composition

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What is the Typical Makeup of a DMC? !   3 to 7 members !   Generally includes statistician and clinician

familiar with disease !   Sometimes includes ethicist, especially when

certain issues or concerns are anticipated !   Sometimes includes researchers with special

expertise relevant to the type of trial !   Increasingly includes patient advocates

DMC Membership

Member Qualifications

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DMC Member Qualifications

Category Special Expertise Chairperson Experience as a DMC member

Leadership skills Statistician(s) Design and conduct of clinical trials

Group sequential and adaptive research designs Clinician(s) Natural disease history

Standard treatments and toxicities Ethicist(s) Balancing needs of trial patients vs. benefits to others Patient Advocate(s)

Patients’ perspectives on benefits vs. risks, quality of life considerations

Specialist Relevant to Trial

Expertise in drug safety Expertise in study endpoints

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Sample Quotes from Focus Groups: What Qualifications Do DMC Members Need?

!   There are no standards or guidelines pertaining to DMC members and their qualifications—and that is a problem

!   Expertise should be broad enough to adequately address safety issues that may arise

!   Not only should DMC members have disease-specific expertise, but they also need to understand complex data and challenges of interpreting the data

!   Members should be independent and have minimal conflicts of interest; regular reporting of conflicts and transparency are critical

!   Prior experience on DMCs is valuable !   Sound judgment and ability to “play well with others”

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Sample Quote from Focus Groups: What Qualifications Do DMC Chairs Need?

!   A key qualification of the DMC chair is prior DMC experience

!   The chair needs to know how to: –  Run a meeting –  Listen carefully and know when not to talk –  Build consensus

! Most important qualifications of a DMC chair are: –  Focus –  Judgment –  Experience in the DMC process—not just medical expertise

!   Ensure all members are involved and have a voice

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Do you believe there are special DMC needs in the context of adaptive design trials?

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26%

63%

21%

8%

77%

19%

0% 25% 50% 75% 100%

Yes, other special needs

Yes, special training for the DMC members

No

All Organizers All DMC Members

DMC Membership

Identification of DMC Members

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How are DMC Members Identified? Survey All Organizers

2%

2%

12%

22%

67%

67%

61%

61%

0 12 24 36 48

0% 25% 50% 75% 100%

Training program participants

Other

I do not identify potential DMC members

Literature search (journal articles and listed refs of other pubs)

They have served on DMCs for other studies I’m aware of

They have served on previous DMCs for my specific studies

Recom. by others as having DMC experience

Recom. based on expertise or reputation, w/ no or unk. DMC experience

Responses from 49 Respondents 12

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How are DMC Members Identified? Survey All Members

Investigator contact Board that supplies members

4%

21%

39%

40%

74%

0 20 40 60

0% 25% 50% 75% 100%

Other

Asked by a colleague with knowledge of the study (who isn't

currently serving on the DMC)

Asked by current members or chair of the DMC to join

CRO or ARO managing the study contacted me

Sponsor Contacted Me

Responses from 72 Respondents

DMC Membership

Developing the Next Generation of DMC Members

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33%

67%

0 2 4 6

After

Before

Responses from 6 Respondents

Did the training occur before or after joining your first DMC?

Would you have preferred to have been trained BEFORE serving on a DMC?

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92%

8%

0 20 40 60

0% 25% 50% 75% 100%

No

Yes

Responses from 72 Respondents 0%

100%

No

Yes

Response from 2 Respondents

Have you ever been formally trained to serve on a DMC? (all members)

Are DMC Members Trained? Should they Be?

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Do Sponsors Require Trained DMCs?

10 2 10 16 4

0% 25% 50% 75% 100%

Always Most of the time Sometimes Rarely Never Not Sure

Do Sponsors Offer Training?

3 6 10 20 6

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Always Most of the time Sometimes Rarely Never Not Sure

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Training Summary

!   Few DMC members have received training, but most would have liked it

!   Few sponsors require training or are aware of relevant training programs

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What Should be Included In Training?

– Didactic sessions that provide basic information (e.g., regulations, charters, communication expectations)

–  Interactive sessions (e.g.,

discussion of case studies) – Ongoing/continuing

education and mentoring

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What Role Should Government Play?

!  Government does have knowledge. Academia is where the real expertise is.

!  Relevant professional organizations (e.g., SCT) can play a role in training—more so than gov’t.

!   “Government would be happy to help develop training sets across the NIH

!   A uniform course would help sponsors and investigators to understand the role of the DMC.

Industry Sponsor Responses

Government/ Non-Profit Responses

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Other than Formal Training, What Should be Done to Prepare the Next Generation of DMC Members?

!   Non-voting observers !   Apprenticeships and mentoring !   Learn on the job

CONNECT WITH CTTI www.ctti-clinicaltrials.org

Thank you.

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Project Next Steps !   Work groups currently developing proposed

recommendations based on evidence !   Gather feedback on proposed

recommendations at an upcoming expert meeting

!   Refine, finalize and disseminate recommendations

!   Develop implementation project(s) to facilitate adoption of recommendations

CONNECT WITH CTTI www.ctti-clinicaltrials.org

Thank you.