As documented in a recent JAMA viewpoint article, the US FDA is making moves to integrate patient perspectives throughout the continuum of medical product development. While the FDA and other key stakeholders have declared a commitment to create a more effective model for engagement between research sponsors, investigators, and patient groups, no evidence-based guidelines for best practices have existed, until now.

On October 7, CTTI released recommendations that identify evidence-based best practices for engaging with patient groups, as well as provide case examples and tools. These recommendations are the result of CTTI’s Patient Groups & Clinical Trials Project.

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? We are proud to offer actionable solutions to these questions around patient engagement and encourage you to share them with colleagues involved in the clinical trials enterprise.

“The FDA is committed to integrating patient perspectives into its regulatory evaluations and decision making and also encourages medical product innovators and clinical researchers to collect information on patient perspectives to inform development programs.” (Source: JAMA)

On October 14, 2015, PLoS ONE published Patient Engagement Practices in Clinical Research among Patient Groups, Industry, and Academia in the United States: A Survey. Written by members of CTTI’s Patient Groups & Clinical Trials Project, the objective of this publication was, “to gain a better understanding of attitudes and practices for engaging patient groups so that actionable recommendations may be developed.” After analyzing data from 179 survey respondents, significant differences were detected between “stakeholder groups in perceptions of the value of patient group engagement with academia and industry around clinical trials- finding that may represent a significant barrier to engagement that was not identified by the individual stakeholder groups independently.”

In addition to this publication, this CTTI project also developed Official Recommendations on Effective Engagement with Patient Groups around Clinical Trials.

We are pleased to share these free resources, and encourage you to share them with friends and colleagues active in the clinical trials enterprise.

If you are active on Twitter, you can participate in this ongoing conversation with #PGCT.

Last week, team members from CTTI’s Patient Groups & Clinical Trials Project presented the official recommendations on effective engagement with patient groups around clinical trials in a public webinar. Released on October 7, 2015, these recommendations identify evidence-based best practices for engaging with patient groups, as well as provide case examples and tools.

We are pleased to share the recording of this webinar:

PRESENTERS:

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

CLICK HERE to view the slides from this presentation.

If you are active on Twitter, you can participate in this ongoing conversation with #PGCT.

CLICK HERE to view recordings of other CTTI webinars.