Patient Engagement

You’re Invited! Upcoming Webinar Presents CTTI Recommendations: Effective Engagement with Patient Groups Around

Posted on by Lorri Bingham

Patient Groups

On Thursday, October 15, 2015, team members from CTTI’s Patient Groups & Clinical Trials project will present the official recommendations on effective engagement with patient groups around clinical trials. Released on October 7, these recommendations identify evidence-based best practices for engaging with patient groups, as well as provide case examples and tools. This webinar is open to the public, and we encourage you to share this invitation with colleagues involved in the clinical trials enterprise.

Webinar Title: Presenting CTTI Recommendations: Effective Engagement with Patient Groups Around Clinical Trials

Date: Thursday, October 15, 2015 Time: 12:00 – 1:00 pm EST

Presenters:

  • Sharon Hesterlee (Myotonic Dystrophy Foundation)
  • Patricia Cornet (Bristol-Myers Squibb)
  • Scott Weir (KUMC)

Link: CLICK HERE to access the webinar during the scheduled time
Meeting number: 733 697 012
Meeting password: cttiPGCT

Or join by phone only:
1-855-244-8681 Call-in toll-free number (US/Canada)
1-650-479-3207 Call-in toll number (US/Canada)
Access code: 733 697 012

To join the conversation on Twitter, follow the #PGCT hashtag and @CTTI_Trials.

Finally! Evidence-based Recommendations & Tools to Maximize Effective Engagement Between Patient Groups & Sponsors

Posted on by Lorri Bingham

While key stakeholders have declared a commitment to create a more effective model for engagement between research sponsors, investigators and patient groups, thus leading to more efficient, quality-driven clinical trials, no evidence-based guidelines for best practices have existed until now. How and when should patient groups be engaged in the research and development continuum? How do patient groups and sponsors of research best assess each other’s interests, expertise and assets to increase the chances of successful clinical trials and therapy development?

In January 2014, CTTI initiated the Patient Groups & Clinical Trials (PGCT) Project to find evidence-driven, actionable solutions to these questions. Today, we are pleased to release the culmination of these efforts at the BIO Patient and Health Advocacy Summit session titled, Best Practices for Industry and Patient Organization Collaboration in Clinical Trials. (CLICK HERE to view the slides presented at this session.) CTTI’s PGCT official recommendations identify best practices for engaging with patient groups, as well as provide case examples and tools.

CLICK HERE to download a copy of the PGCT recommendations.

To join the conversation on Twitter, follow the #PGCT hashtag and @CTTI_Trials.

CTTI’s Patient Engagement 2.0 Strategy seals Patient Groups as Equal Partners in the Clinical Research Process

Posted on by Lorri Bingham

While patient representatives have been engaged since its inception, CTTI underscored the vital importance of meaningful patient engagement in the clinical trials enterprise (CTE) by launching its Patient Leadership Council (PLC) in January 2013. Through the PLC, 15 patient thought leaders representing a variety of organizations engaged in clinical trials came together, outside of disease or body part, to work hand in hand with CTTI’s diverse membership to create solutions. Since the establishment of the PLC, this group’s impact on CTTI’s work has been undeniable.

Not only did PLC members increasingly serve as project team leaders and integral team members, CTTI’s membership and Executive Committee fast-tracked approval of a project developed by the PLC entitled Patient Groups & Clinical Trials–which follows CTTI’s multi-stakeholder approach and aims to identify and promote best practices for effective engagements between sponsors of research and patient groups around clinical trials. The PLC also created presentations and events for CTTI’s membership that highlighted innovative programs and approaches developed by patient groups to overcome barriers in clinical trials.

In light of the impact made in the PLC’s first 18 months, CTTI convened a Summit with its patient representatives in July 2014 to explore lessons learned and define what Patient Engagement 2.0 should look like at CTTI. On this day, it was affirmed that the greatest accomplishments were achieved by working in direct partnership with other stakeholders and that panels had greater impact when voices from diverse stakeholder groups were included. Thus, the PLC decided it should be dissolved and its members integrated into CTTI’s Steering Committee as of January 2015. Furthermore, representatives of the patient community should have responsibilities and representation equal to all other stakeholders at CTTI. In the case of patient advocacy organizations, this includes applying and paying a nominal annual fee for membership rather than being convened as a distinct entity via invitation. The leaders recommended that individual patient and caregiver representatives should continue to be selected via competitive process for positions that include travel support to ensure their ability to participate.

In sum, the message from this body of thought leaders is clear: The patient community must be equal partners in every aspect of the clinical trial enterprise in order to improve the quality and efficiency of clinical trial; Patient Engagement 2.0 is a final step for achieving this at CTTI. Stay tuned for recommendations from CTTI’s project on Patient Groups & Clinical Trials. For information on applying for CTTI membership, click here.

CTTI Presents on Overcoming Barriers to Effective Patient Engagement in Clinical Trials at DIA’s Upcoming Interactive Workshop

Posted on by Lorri Bingham

Bray Patrick-Lake, CTTI Director of Stakeholder Engagement, will discuss preliminary results of a CTTI-DIA patient engagement survey at the DIA workshop Patient Engagement throughout the Full Spectrum of Drug Development: An Interactive Workshop for Life Science Companies and Patient Groups.

Ms. Patrick-Lake will share the insights provided by more than 250 patient groups, investigators, and research sponsors on current US practices and perceived barriers for engaging with patient groups in clinical discovery and research, including clinical trial development and execution. Her talk will lead off a series of participatory discussions in which workshop attendees will share their perspectives on expectations and needed outcomes for patient engagement, current aspects that are working well, and problems that must be addressed to achieve meaningful improvement of engagement practices and outcomes.

This two-day workshop will be help on October 29-30, 2014 in Washington, DC. For registration information, CLICK HERE.

Participate in our Survey on Current Practices for Engagement with Patient Groups in Clinical Discovery & Research

Posted on by Lorri Bingham

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