Invitation to Apply as a CTTI Patient/Caregiver Representative
Dear Members of the Patient/Caregiver Community,
At CTTI, we engage all stakeholders, including patients as equal partners to analyze existing
research impediments and recommend consensus-driven, actionable solutions that will lead to a
more sustainable and effective clinical trial system.
Patients and caregivers seek rapid access to safe and effective new drugs, devices and
biological products, but also want adequate data to understand the benefits and risks of these
products and how they are optimally utilized. This type of information is typically acquired by
conducting a randomized controlled trial. Inefficiencies in conducting trials threaten the capacity
to generate the evidence needed to evaluate products, to determine best medical practice, and
to compare the effectiveness of therapeutic and diagnostic alternatives
The mission of the Clinical Trials Transformation Initiative — co-founded in 2007 by Duke
University and the US Food and Drug Administration (FDA), and hosted by Duke University —
is to help address this crisis by identifying and promoting practices that will increase the quality
and efficiency of clinical trials.
CTTI’s approach includes conducting projects to better understand the range of current
practices, assess alternative approaches, understand barriers to change, and propose
recommendations for improvement. Members contribute ideas for projects, participate in their
conduct and analysis, and are committed to disseminating CTTI recommendations and
encouraging adoption of system changes that will improve the efficiency of clinical trials. Our
membership of more than 70 organizations comprises various parties including academic
research organizations, patient groups, industry, government, institutional review boards (IRBs)
and investigators.
If after reviewing CTTI’s website, project portfolio, and videos you are interested in working with
others to identify ways to make clinical trials more efficient and of higher quality, we invite you to
apply for membership. Organizations may apply here. Individual patient or caregiver advocates
may apply via a competitive selection process currently open through December 10, 2014
below. Ultimately the remedy for our ailing clinical research system depends on the collective
effort of all constituents involved in the clinical trials process; CTTI provides an optimal venue
for this collaboration. I hope you will consider applying to be a part of this exciting partnership
and look forward to talking to you.
Thank you,
Pamela Tenaerts, MD, MBA
Executive Director, Clinical Trials Transformation Initiative
CTTI Patient/Caregiver Representative Application
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Background Information for CTTI Patient/Caregiver Representatives
*Before applying, individuals should review the following information to understand the
expectations of the position:
Selection Criteria for CTTI Patient Representatives
Patient or caregiver with:
 Willingness to commit time and effort to CTTI’s mission and projects
 Understanding of clinical trial system and regulations
 Previous experience with efforts to improve clinical trials
 Experience working in a constructive manner with diverse stakeholders
 Well-positioned within the advocacy community to gather input for CTTI initiatives
and communicate CTTI's work to the patient/caregiver community and others within
the clinical trial ecosystem
 Public speaking skill and experience desirable
Expectations for Patient Representatives
 Support CTTI's mission within patient advocacy communities
 Attend and actively participate in Steering Committee meetings, webinars and
conference calls
o 2 biannual meetings in DC area (Sept/Oct and Mar/Apr, travel stipend
provided)
o Quarterly 1-hour webinars (typically over the lunch hour Eastern time)
o Additional opportunities to provide patient voice for CTTI project expert
meetings (travel stipend provided)
 Serve as a member and/or co-lead of project teams and subcommittees
o Attend project team calls (1-hour monthly), face-to-face and expert meetings
(1-2 per yr, travel stipend provided)
 Patient stakeholder meetings
o Nested within biannual Steering Committee meetings and 4-6 hours of
additional calls or webinars annually
 Seek opportunities to promote CTTI’s work and engage others in implementing
CTTI’s recommendations
Terms
 3-year term with opportunity to be extended by the Patient Rep Selection
Subcommittee for 1 year based on participation and performance
 CTTI values collaboration, constructive dialogue, mutual respect, and solutionoriented thinking. Thus, CTTI reserves the right to bring a term to close early
with approval of the Patient Rep Selection Subcommittee should a representative
not be a good fit with the organizational values or fail to meet the expectations
listed above.
CTTI Patient/Caregiver Representative Application
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Application to Serve as CTTI Patient/Caregiver Representative
*This is the only portion of the application packet that needs to be submitted to CTTI.
NAME:
ORGANIZATIONAL AFFILIATION(S):
HOME ADDRESS:
PHONE:
EMAIL:
1) Describe your experience as a patient/caregiver advocate in the development,
implementation and regulation of clinical research, and in particular experience with
efforts to improve clinical trial processes. Please also list any experience as a
participant in a clinical trial. See attached graphic of patient/caregiver roles in the
clinical trials continuum for examples.
2) Provide examples that illustrate your ability to effectively represent patients on multistakeholder committees and initiatives.
3) List any advocacy related presentations or publications.
4) List 2 – 3 references who have worked with you in the advocacy activities described
above.
5) List industry and other commercial organizations that financially support you and/or
your organization. If you or your organization receives payment for services you provide
to a commercial organization (or an organization representing commercial interests), list
the names of the commercial organizations and describe the nature of the services
provided.
Please submit this form along with a current advocacy Curriculum Vitae (or resume) to
CTTI@mc.duke.edu by 5:00 pm ET on December 10, 2014.
CTTI Patient/Caregiver Representative Application
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Appendix: Illustration of Patient Roles in the Clinical Trials Continuum
CTTI Patient/Caregiver Representative Application
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