Patient Engagement

Watch CTTI-hosted Webinar on FDA’s Patient Engagement Initiatives

Posted on by Hannah Faulkner

The FDA’s large portfolio of activities to integrate patient engagement throughout the agency was highlighted during a recent CTTI-hosted webinar, now available to watch online. “Patient Engagement in Action: Insights from Patients & the FDA” was held Thurs., Nov. 21, and featured:

  • Andrea Furia-Helms, OC, FDA
  • Michelle Tarver, CDRH, FDA
  • Robyn Bent, CDER, FDA
  • Diane Maloney, CBER, FDA
  • Theresa Strong, Foundation for Prader-Willi Research

“Patients are at the heart of all FDA activities,” Furia-Helms said. She kicked off the webinar with an overview of the history of patient engagement at the FDA. Participants then reviewed patient engagement activities throughout the process of development and regulatory decision-making for drugs, biologics, and devices.

Bent said that patients are uniquely positioned to inform understanding of the therapeutic context for drug development and evaluation. She added that there is a need for more systematic ways of gathering patient perspectives on their conditions and treatment options.

Strong spoke from the perspective of a patient advocate working with the FDA. She said that the patient perspective, particularly with rare diseases, provides context and nuance to the associated symptoms and challenges within a disease. “We bring some experience about living with the disorder and can hopefully help FDA staff understand that laundry list of symptoms, and tease out what is important to patients and what is keeping people living with Prader-Willi syndrome from living healthy and productive lives.”

CTTI and the FDA have partnered on several patient engagement efforts, including co-creating the Patient Engagement Collaborative (PEC) and collaborating on a recent “Enhancing the Incorporation of Patient Perspectives in Clinical Trials” workshop. Additionally, CTTI has developed a robust set of recommendations and resources that help foster effective patient group engagement.

Additionally, answers to the virtual Q&A session are available here.

Now Available: Summary of the September Patient Engagement Collaborative Meeting

Posted on by Hannah Faulkner

A summary of the most recent meeting of the Patient Engagement Collaborative (PEC) is now available. The PEC, which is convened jointly by the FDA and CTTI to discuss how the FDA can bolster patient engagement in its activities, met in September in Rockville, Md.

The primary objective of the PEC’s meeting was to discuss an FDA Ambassador program, which emerged from the group’s March 2019 meeting as a potential avenue to help the patient community engage with the FDA. The PEC discussed potential audiences for the program, as well as the most effective ways to communicate with these audiences. The collaborative also discussed changes the FDA plans to make to its website to make it easier for patients to navigate.

The PEC, which was established in December 2017, is composed of 16 members representing diverse patient communities across the U.S. CTTI and FDA are extending the terms of the initial members by one year, and look forward to engaging new perspectives through an open call for new nominations as current member complete terms in 2021 and 2022. This effort is facilitated by provisions in the 21st Century Cures Act of 2016 and the Food and Drug Administration Reauthorization Act of 2017.

To learn more about other efforts by CTTI and the FDA to further patient engagement, please attend CTTI’s webinar, “Patient Engagement in Action: Insights from Patients & the FDA” on Nov. 17 at noon ET.

FDA Patient Engagement Efforts Highlighted in CTTI-hosted Webinar

Posted on by Hannah Faulkner

Are you curious about what the FDA is doing to integrate patient engagement throughout the agency? Wondering how CTTI is collaborating on some of these efforts? Learn about a variety of initiatives during a CTTI-hosted webinar Thurs., Nov. 21, from 12:00 – 1:00 p.m. ET.

Confirmed speakers for “Patient Engagement in Action: Insights from Patients & the FDA” include:

  • Michelle Tarver, CDRH, FDA
  • Robyn Bent, CDER, FDA
  • Diane Maloney, CBER, FDA
  • Andrea Furia-Helms, OC, FDA
  • Theresa Strong, Foundation for Prader-Willi Research

Participants will discuss ongoing and planned patient engagement initiatives and the anticipated impact of these efforts on patients and clinical research.

Add the webinar to your calendar today.

CTTI Launches New Tool to Help Identify High-Value Patient Engagement Opportunities

Posted on by Lorri Bingham

As part of its commitment to promote the engagement of patients as equal partners in clinical research, CTTI launched a new tool today at the 2019 DIA Global Annual Meeting that will help sponsors and patient groups identify high-value opportunities to collaborate.

The free web-based tool walks users through a three-step prioritization process:

  1. Identify relevant engagement activities. Patient groups and sponsors first identify all potential opportunities to collaborate, working from a comprehensive list developed by CTTI and adding their own fit-for-purpose activities.
  2. Evaluate benefits and investments. After reviewing factors identified by CTTI research, sponsors and patient groups rate the benefit and investment of each activity.
  3. Identify mutually beneficial activities. Research sponsors and patient groups compare and discuss their respective priorities and decide on opportunities that are of high value for each. A benefit/investment matrix helps visualize priorities and support discussion.

The tool is part of CTTI’s Patient Groups & Clinical Trials work, which encourages sponsors, investigators, and other stakeholders to engage with patient groups early and often for better and more efficient clinical trials.

“This new prioritization tool builds on the foundational work CTTI has already completed and ensures that collaboration is focused on areas where the greatest benefit can be achieved for everyone involved, given limited resources,” said CTTI Executive Director Pamela Tenaerts. “With an easy, three-step process, the tool helps create and identify high-value opportunities for patients and sponsors to engage in the clinical research enterprise.”

Linda Brennan, director of community partnerships at the Cystic Fibrosis Foundation, and Jaye Bea Smalley, director of patient advocacy and life cycle management for inflammation and immunology at Celgene Corporation, will publicly introduce the tool in the “Identifying High-Value Patient Engagement Opportunities: A Collaborative Three-Step Process for Sponsors and Patient Groups” DIA 2019 session at 8 a.m. PT.

CTTI to Focus on Three Key Areas of Clinical Research Improvement and Innovation at DIA 2019

Posted on by Lorri Bingham

At this year’s DIA 2019 Global Annual Meeting, CTTI will share insights from three key areas of its work dedicated to enhancing the quality and efficiency of clinical trials. At the event, which will take place in San Diego from June 23-27, CTTI will present its recommendations and resources for enhancing patient engagement, investigator qualification, and the use of mobile technology in clinical research. Please join us at the following presentations:

Presentation: Measuring the Impact of Patient Engagement Activities in Medicines R&D: A Way to Sustain Cultural Change

Date & Time: Tues., June 25, 2:00 – 3:15 p.m. PT (GMT-07:00)

Presenter: Jaye Bea Smalley (Celgene Corporation)

Related CTTI Project: Patient Groups & Clinical Trials

Presentation: Identifying High-Value Patient Engagement Opportunities: A Collaborative Three-Step Process for Sponsors and Patient Groups

Date & Time: Wed., June 26, 8:00 – 9:15 a.m. PT (GMT-07:00)

Presenters: Linda Brennan (Cystic Fibrosis Foundation) and Jaye Bea Smalley (Celgene Corporation)

Related CTTI Project: Patient Groups & Clinical Trials

Presentation: Improving Trial Quality by Better Preparing Site Teams

Date & Time: Wed., June 26, 8:00 – 9:15 a.m. PT (GMT-07:00)

Presenters: Sabrina Comic-Savic (The Medicines Company), Christine Hildebrand (Amici Clinical Research), Jimmy Bechtel (SCRS), Janette Panhuis (Population Health Research Institute, McMaster University), Ronnie Todaro (Parkinson’s Foundation)

Related CTTI Project: Investigator Qualification

Presentation: Demystifying Technology Selection in Mobile Clinical Trials

Date & Time: Wed., June 26, 8:00 – 9:15 a.m. PT (GMT-07:00)

Presenters: Aaron Coleman (Fitabase), Barry Peterson (Wearable Devices, Independent Consultant), Isaac Rodriguez-Chavez (FDA/CDER), and Thomas Switzer (Genentech―a member of the Roche Group)

Related CTTI Project: MCT Mobile Technologies

Presentation: A New Path Forward for Using Decentralized Clinical Trials

Date & Time: Wed., June 26, 4:15 – 5:30 p.m. PT (GMT-07:00)

Presenters: Gail Adinamis (GlobalCare Clinical Trials), Michael O’Brien (The Avoca Group), Laura Podolsky (Science 37), and Penny Randall (IQVIA)

Related CTTI Project: MCT Decentralized Clinical Trials

Now Available: Summary of the March Patient Engagement Collaborative Meeting

Posted on by Lorri Bingham

The FDA, in collaboration with CTTI, convened the second in-person meeting of the Patient Engagement Collaborative (PEC) in March at the FDA’s White Oak Campus in Silver Spring, Md. A summary of the meeting is now available.

The primary objective of the PEC’s most recent meeting was to discuss a “how-to guide” to help patients and patient groups navigate engaging with the FDA. Ideas for new resources included a patient ambassador training program and informational marketing campaigns to meet patients where they live and work.

The PEC, a joint initiative of the FDA and CTTI, has 16 members who were chosen from nearly 200 patients and patient advocates. The members’ discussions help to inform the FDA’s efforts to engage patients meaningfully in medical product development and other regulatory discussions.

This effort is facilitated by provisions in the 21st Century Cures Act of 2016 and the Food and Drug Administration Reauthorization Act of 2017.

Webinar Now Available: CTTI’s New Recommendations for Engaging Patients and Sites in Mobile Trials

Posted on by Lorri Bingham

A recording is now available of the public webinar on Thurs., Feb. 21, to launch CTTI’s new recommendations for incorporating patient and site perspectives in mobile clinical trials. The webinar was led by patient advocate Cindy Geoghegan and Virginia Nido of Genentech, a member of the Roche Group.

CTTI conducted qualitative and quantitative research to better understand the perceptions of patients and site personnel, and convened experts and leaders across the clinical trials enterprise to develop actionable recommendations and resources.

“Patients are attracted to the possibilities of greater convenience and greater access to clinical research—fewer visits, less time away from work and family, and less burden on their caregivers,” Geoghegan said. “Our goal was to enhance the experience for both patients and hard-working site staff.”

The resulting recommendations are designed to help research sponsors engage patient and site perspectives in planning mobile trials, maximize value and minimize burden for study participants, and address challenges for investigative sites.

“One of the key messages is the importance of planning,” Nido said. “We are new to this as an industry, and we need to plan for and address these new challenges in order to maximize the benefits of mobile technology in clinical trials.”

This is the final of four sets of recommendations CTTI has released as part of its Mobile Clinical Trials (MCT) Program. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies and, in 2018, it unveiled new solutions for using mobile technologies for data capture in clinical trials, and recommendations for using decentralized clinical trials. Additionally, they build on previous CTTI work—including our Quality by Design and Patient Groups and Clinical Trials recommendations—that emphasizes the involvement of many stakeholders, including patients and sites, in trial design.