Patient Engagement

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 Webinar Invitation: MDIC’s Patient Centered Benefit-Risk Framework

Posted on by Lorri Bingham

On August 20, CTTI will host a public 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 take part in this event.

The goal of MDIC’s PCBR was to establish a credible framework for defining patient preferences on the benefits and risks of new medical technologies that might be incorporated into the regulatory approval process. Board Member and Project Board Champion, Ross Jaffe will give an overview of this newly released report: “A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technologies.” The webinar will also include Kathryn O’Callaghan from FDA’s Centers for Devices and Radiological Health (CDRH), who will discuss the FDA’s new draft guidance, “Patient Preference Information- Submission, Review in PMAs, HDE Applications, and DeNovo Requests, and Inclusion in Device Labeling“, issued on May 13th.

Webinar Details:

  • Title: Integrating Patient Preferences into the Regulatory Review of Medical Devices
  • Date/Time: August 20, 12:00-1:00 p.m. EST
  • WebEx Link: Click here (Meeting Number: 738 915 200 and Meeting Password: ctti)

We encourage you to forward this invitation to colleagues involved in the clinical trials enterprise.

#DIA2015 Wrap-Up: CTTI Conference Materials Available Online

Posted on by Lorri Bingham

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

DIA SESSION: THE CLINICAL TRIALS TRANSFORMATION INITIATIVE DATA MONITORING COMMITTEE PROJECT: FINDINGS AND NEXT STEPS

 

DIA SESSION: TRANSLATING NEW KNOWLEDGE FROM REGULATORY SCIENCE INTO POSTMARKETING SAFETY PRACTICE

 

DIA SESSION: BEST PRACTICES FOR EFFECTIVE ENGAGEMENT WITH PATIENT GROUPS AROUND CLINICAL TRIALS

 

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

Posted on by Lorri Bingham

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.

Expert Meeting Summary Available: Thought Leaders Lay Foundation for Effective Engagement with Patient Groups

Posted on by Lorri Bingham

Key stakeholders in the clinical trials enterprise have declared a commitment to create a more effective model for engagement between research sponsors, investigators and patient groups, leading to better clinical trials; however, no guidelines for best practices currently exist. Actionable recommendations are needed, and CTTI is working to address this unmet need.

On January 21-22, 2015, CTTI convened a multi-stakeholder group of experts and thought leaders from across the clinical trials enterprise to address barriers to patient group engagement. Specifically, the meeting attendees set out to:

  • Define consensus principles of Patient Group engagement from the 3-way (Industry, Patient Group, and Academia) stakeholder perspectives using case studies of success and barriers
  • Share evidence and key findings from a multi-stakeholder assessment of Patient Group engagement in the Clinical Trial process
  • Gain understanding of the FDA Rules of Engagement and various Conflict of Interest (COI) issues
  • Solicit feedback on evidence to inform recommendations that can further enhance the value to industry, academia and patient groups of mutually beneficial partnerships that engage the patient groups as fully as possible in the complete spectrum of the clinical research enterprise
  • Solicit feedback on benchmarking, metrics, and value of patient engagement in clinical trials for research sponsors

In addition to providing the presentation materials from this expert meeting, we are pleased to share the summary as well. These materials describe the current landscape of patient engagement, and provide an evidence-based foundation for moving forward.

 

CLICK HERE TO VIEW THESE MEETING MATERIALS.

CTTI and Precision Medicine

Posted on by Lorri Bingham

On January 30, 2015, President Obama unveiled details about the Precision Medicine Initiative, a new research effort intended to revolutionize how we improve health and treat disease. Several CTTI affiliates were invited to take part in the announcement. After an afternoon in the White House, the synergy between this federal initiative and CTTI’s work was clear.

CTTI co-chair Dr. Robert Califf found the event to be a call-to-action for CTTI to redouble efforts to streamline clinical trials, so that accelerated technology development can lead to practice based on high quality evidence. Furthermore, CTTI’s pioneering work in patient engagement is consonant with the proposed new model of patient-powered research to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients.

Following the presidential announcement, 30 leaders from the patient community joined NIH Director Francis Collins for lunch to explore their hopes and fears about the effort. CTTI’s director of stakeholder engagement, Bray Patrick-Lake, was in attendance and reports that members of the patient community spoke to their great hopes in the science and commitment of NIH and the White House. These sentiments were perhaps best stated by 11-year-old rare disease patient Beatrice Rienhoff who said it was the best day of her life; however other patients articulated that fears remain around the IRB and informed consent impediments in the current research system. This makes CTTI’s work on these topics and others even more timely, relevant and urgent.

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 Highlights Patient Partnerships at Upcoming FDA & SCT/QSPI Workshop

Posted on by Lorri Bingham

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

Posted on by Lorri Bingham

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:

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