Patient Group Engagement
CTTI Webinar Now Online: Integrating Patient Preferences into the Regulatory Review of Medical Devices
On August 20, 2015, CTTI hosted a webinar featuring the Medical Device Innovation Consortium (MDIC) and their recently released Patient Centered Benefit-Risk Assessment (PCBR). CTTI’s Director of Stakeholder Engagement, Bray Patrick-Lake, participated in the development of the PCBR framework and we are pleased to share the recording of this event:
PRESENTERS:
- Ross Jaffe, Managing Director, Versant Ventures; Director, National Venture Capital Association; Board Champion, MDIC
- Kathryn O’Callaghan, Associate Center Director for Science & Strategic Partnerships, FDA CDRH
CLICK HERE to view recordings of other CTTI webinars.
You’re Invited! Upcoming Webinar Presents CTTI Recommendations: Effective Engagement with Patient Groups Around
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.
#DIA2015 Wrap-Up: CTTI Conference Materials Available Online
The DIA’s 51st Annual Meeting earlier this month was a great success. In addition to presenting preliminary findings from several CTTI projects, we also unveiled the official recommendations and associated Toolkit from our Quality by Design (QbD) Project. We’d like to thank all of our colleagues who came together for a week of engaged discussion and learning.
We are now happy to share the materials from CTTI’s presentations. We hope you find them useful in your efforts to improve the quality and efficiency of clinical trials.
DIA SESSION: CLINICAL QUALITY BY DESIGN: FROM THEORY TO PRACTICE
- Clinical Quality-by-Design (QbD): Principles to Practice by Coleen Glessner, Pfizer, Inc.
- Clinical Quality By Design: FDA Point of View by Jean Mulinde, CDER, FDA
- CLICK HERE for more information on CTTI’s Quality by Design Project.
DIA SESSION: THE CLINICAL TRIALS TRANSFORMATION INITIATIVE DATA MONITORING COMMITTEE PROJECT: FINDINGS AND NEXT STEPS
- Introduction to the CTTI Data Monitoring Committees Project by Karim Calis, CDER/FDA and NICHD/NIH
- The Clinical Trials Transformation Initiative Data Monitoring Committee Project: Findings and Next Steps by Susan Ellenberg, University of Pennsylvania
- CTTI DMC Project Survey and Focus Group Findings: Communication Practices by Ray Bain, Merck Research Laboratories
- DMC Qualification, Composition and Training by Jane Perlmutter, Patient Advocate
- CLICK HERE for more information on CTTI’s Data Monitoring Committee Project.
DIA SESSION: TRANSLATING NEW KNOWLEDGE FROM REGULATORY SCIENCE INTO POSTMARKETING SAFETY PRACTICE
- The Clinical Trials Transformation Initiative IND Safety Advancement Project: Findings and Next Steps by Michael Jones, Eli Lilly & Company
- CLICK HERE for more information on CTTI’s IND Safety Advancement Project.
DIA SESSION: BEST PRACTICES FOR EFFECTIVE ENGAGEMENT WITH PATIENT GROUPS AROUND CLINICAL TRIALS
- CTTI Patient Groups and Clinical Trials: Building the Value Model by Matthew Harker, CTTI
- Progress Through Partnership: Actively Engaging Patient Groups in the Clinical Research Process by Petra Kaufmann, NCATS/NIH
- CTTI Patient Groups and Clinical Trials Industry Measurements by David P. Leventhal, Pfizer, Inc.
- CLICK HERE for more information on CTTI’s Patient Groups & Clinical Trials Project.
DIA POSTER: RESULTS OF AN ONLINE SURVEY OF STAKEHOLDERS REGARDING BARRIERS AND SOLUTIONS TO CLINICAL TRIAL RECRUITMENT
- CLICK HERE to view a PDF of this poster.
- CLICK HERE for more information on CTTI’s Recruitment Project.
CTTI Director of Stakeholder Engagement Participates in Development & Release of Patient-Centered Framework
Today, the Medical Device Innovation Consortium (MDIC) releases their Patient Centered Benefit-Risk (PCBR) Framework. This framework and the accompanying catalog of methods address the incorporation of information on patient preferences regarding benefit and risk into the regulatory assessments of new medical technologies.
CTTI’s Director of Stakeholder Engagement, Bray Patrick-Lake, participated in the development of this framework, and joins colleagues from the National Health Council, Focused Ultrasound Foundation, and FasterCures for the Discussion on Patient Group Perspective during today’s release. This public event is hosted in Washington, DC and attendees are welcomed to join via webinar, as well. For registration information, click here.
“Before approving a new medical device, regulators must evaluate its safety and effectiveness. One of the most important questions they ask is whether the clinical benefit of a device outweighs its risk. It makes sense to consider that question from the perspective of patients as well as researchers and clinicians.”
–MDIC
Bray Patrick-Lake also manages CTTI’s project on Best Practices for Effective Engagement with Patient Groups around Clinical Trials. This project seeks to identify best practices for engaging patient groups that will lead to more efficient and successful clinical trials.
CTTI’s Patient Engagement 2.0 Strategy seals Patient Groups as Equal Partners in the Clinical Research Process
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 Highlights Patient Partnerships at Upcoming FDA & SCT/QSPI Workshop
On December 9-10, 2014, the FDA and SCT/QSPI will host an interactive workshop titled Innovations in the Science and Practice of Clinical Trials in Rockville, Maryland. This multidisciplinary workshop brings together thought leaders from the FDA, industry, academia, and patient groups for direct and open discussions on recent innovations in the science and practice of clinical trials.
On Wednesday, the session titled Patient Partnership in Clinical Trial Design and Conduct will focus on patient group engagement and regulatory efforts to include patient preferences in decision-making. CTTI’s Patient Leadership Council Liaison on the Executive Committee, Veronica Todaro, will present Patient Engagement in the Clinical Trial Enterprise, followed by CTTI member Sharon Hesterlee presenting Current Patient Engagement Practices in Clinical Trials — A Survey.
We look forward to connecting with our colleagues at this event. To view the detailed program for this event, click here.
If you are interested in patient partnerships in clinical trials, you should know about CTTI’s project, Best Practices for Effective Engagement with Patient Groups around Clinical Trials. The objective of this project is to identify best practices for engaging patient groups that will lead to more efficient and successful clinical trials. Hesterlee’s presentation on Wednesday is connected to this project.
CTTI Speaks to Patient-Centeredness & Innovation in Clinical Trials at Upcoming Partnering for Cures Conference
On November 16-18, 2014, FasterCures will host their 6th Annual Partnering for Cures conference in New York City. This meeting will provide a platform to bring “together leaders from all sectors in medical research with the express purpose of making collaboration happen – collaborations that must happen if we are to speed up the time it takes to turn discoveries into treatments and cures” (partneringforcures.org). If you are attending this conference, we encourage you to engage with CTTI at one of the following events.
CTTI AT PARTNERING FOR CURES 2014:
Event Type: Breakfast Affinity Roundtable
Topic: Rethinking clinical trials
Date & Time: Monday, November 17, 2014 at 7:00 – 8:00 AM
The goal of the Breakfast Affinity Roundtables is to jumpstart networking by organizing informal gatherings of conference attendees who have similar interests. CTTI’s Director of Stakeholder Engagement, Bray Patrick-Lake will be leading the informal discussion focused on innovative approaches to clinical trials.
Event Type: Plenary Panel
Topic: Putting the patients in ‘patient-centeredness’
Date & Time: Tuesday, November 18, 2014 from 3:30 – 4:30 PM
Bray Patrick-Lake will also be speaking at the Partnering for Cures Session that focuses on concrete efforts for patients to be at the center of the medical research system.
To view the conference agenda, along with session descriptions, click here.
If you are on Twitter, we invite you to join the conversation:
- Conference Hashtag: #P4C2014
- CTTI’s Handle: @CTTI_Trials
- Bray Patrick-Lake’s Handle: @BrayPatrickLake
Participate in our Survey on Current Practices for Engagement with Patient Groups in Clinical Discovery & Research
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
CTTI Presents at the SCT 35th Annual Meeting
On May 18-21, 2014, the Society for Clinical Trials (SCT) will be hosting the SCT 35th Annual Meeting in Philadelphia, PA. This meeting is intended for a wide range of professionals representing academia, the pharmaceutical and device industries, government agencies and medical groups and centers. We are pleased to announce that CTTI will be present at this conference to share the ideas and lessons generated from several CTTI projects:
- Team Lead for CTTI’s Central IRB Advancement Project, Cynthia L. Hahn will be presenting in Invited Session 8: Using a Centralized IRB Review Process in the Conduct of Multi-center Trials.
- CTTI’s Director of Stakeholder Engagement, Bray Patrick-Lake will be presenting in Invited Session 14: NINDS INSPIRE Workshop: Patient Engagement & Patient-Centeredness – A Holistic Approach to Clinical Trial Design & Implementation. Key points for this session are related to CTTI’s Patient Groups & Clinical Trials Project.
- Bray Patrick-Lake will also be part of a team leading a pre-conference workshop on May 18, 2014. This half-day workshop (Workshop P7) will take place from 1:00 PM – 5:00 PM and will cover the Best Practices and Innovations in Patient and Community Engagement in Clinical Trials. Advance registration and payment are required for pre-meeting workshops. CLICK HERE to complete the registration form for the SCT 35th Annual Meeting.
We look forward to connecting with the presenters and attendees of the SCT 35th Annual Meeting. Together, we can facilitate change in the clinical trials enterprise.
INNOVATION THROUGH COLLABORATION
If you are attending this conference and active on Twitter, here’s what you need to know:
- Conference Hashtag: #SCT2014
- CTTI’s Twitter Handle: @CTTI_Trials
- Bray Patrick-Lake’s Twitter Handle: @BrayPatrickLake