The Clinical Trials Transformation Initiative (CTTI) and the DIA are co-sponsoring a survey and we’re currently seeking participants. The results of this survey will be used to develop recommendations on Best Practices for Effective Engagement with Patient Groups Around Clinical Trials for CTTI’s purposes and the DIA Patient Engagement Workshop for DIA’s purposes. We aim to gain a deeper understanding of current US practices and perceived barriers for engaging with patient groups in all aspects of clinical discovery and research, including clinical trial development and execution. Your input is critical as the study results could lead to recommendations on best practices for effective engagement with patient groups.
WHO IS BEING ASKED TO PARTICIPATE
Organizational representatives of patient groups, investigators, research sponsors and clinical research organizations.
WHAT WE ARE ASKING OF YOU
You will be asked to complete one brief, 15-20 minute electronic survey. Please note that because the survey is anonymous it is necessary that you complete it before exiting out of your web browser as no unique identifier will link you to your responses.
PLEASE CLICK ON THIS LINK TO COMPLETE THE ANONYMOUS SURVEY:
https://duke.qualtrics.com/SE/?SID=SV_3PdDeqUB4DeLYKp
YOUR ANSWERS WILL BE TREATED CONFIDENTIALLY
We will not be able to link your personal information such as email address and name with your answers. Your answers will be combined with those from others and we will report answers only in aggregate.
HOW YOUR INPUT WILL BE USED
The study results will be used by CTTI to develop additional investigational activities, such as semi-structured interviews and an expert meeting, that lead to recommendations on best practices for effective engagement with patient groups around clinical trials, to be published and used to develop toolkits for the various stakeholder groups. For more information, go to http://bit.ly/1nJ3RPj.
DIA will conduct an interactive workshop for researchers and patient groups to discuss issues identified by the study results and effective approaches for resolution. More information about this DIA activity can be found at www.diahome.org. If you are interested in learning more about participation in CTTI”s investigational activities or DIA’s workshop please email ctti.diasurvey@dm.duke.edu for further information.
WHO WE ARE
CTTI is a public-private partnership, established by the US Food and Drug Administration (FDA) and Duke University, whose membership includes representatives from academic institutions, clinical research organizations, institutional review boards, patient groups, pharmaceutical, biological and device companies, professional societies, US government and other stakeholders within the clinical trials enterprise. CTTI conducts projects in support of its mission to identify and promote practices that will increase the quality and efficiency of clinical trials.
DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Pa., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing).
WHO TO CONTACT FOR QUESTIONS
You should direct any questions or concerns regarding your survey participation to Bray Patrick-Lake at CTTI (bray.patrick-lake@duke.edu). For questions or concerns about your rights as a research subject, you can also contact the Duke Institutional Review Board (IRB) at 919-668-5111.
Thank you for your consideration,
The CTTI Patient Groups & Clinical Trials Project Team Leaders:
- Amy Abernethy, MD, PhD; Associate Professor of Medicine; Director, Center for Learning Health Care; Duke Cancer Research Program
- Sharon Hesterlee, PhD; Parent Project Muscular Dystrophy, Sr. Director of Research & Advocacy
- Richard Klein, FDA, Director of the Patient Liaison Program
- David Leventhal, Pfizer, Director, Clinical Innovation, Worldwide Research & Development
- Jamie Roberts, MA, CCRP; NIH, Clinical Trials Specialist, NINDS
- Wendy Selig, MS; Melanoma Research Alliance, President and CEO
- Sophia Smith, PhD, MSW; Associate Professor, Duke School of Nursing
DIA North America:
- Debra Michaels, Senior Manager, Strategic Content & Policy Assessment