Author: Hannah Faulkner
CTTI to Launch New Embedding Trials Feasibility Assessment Tool
CTTI will host a free public webinar on Thursday, Feb. 29 at 12:00 p.m. EST to unveil a new tool for assessing the feasibility of embedding clinical trial elements into clinical practice.
The webinar will include a welcome from Sara Calvert; a project overview from Lindsay Kehoe; a panel discussion that will focus on stakeholder perspectives related to the practical use of the tool; and an opportunity for you to help CTTI optimize its use.
Embedding elements of clinical trials, such as patient identification, informed consent, and
data acquisition, into routine care reduces duplication of trial and care activities and promotes the
development of a learning health care system. This can naturally lead to better decision-making,
treatment options, and outcomes for patients.
However, integrating interventional clinical trials into clinical practice is complex, and operational direction is needed. Supporting recently released recommendations, CTTI created a new tool that aims to aid sponsors involved in early planning and design of a clinical trial by providing insight into site readiness and feasibility of integrating trials into clinical practice.
Report Now Available: Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies
The report on the two-day virtual public meeting, “Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies (PHEs),” convened by the U.S. Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI), is now available.
The meeting, which was held on October 18 and 19, 2023 with 720 global attendees, discussed recommendations provided by the FDA during the COVID-19 public health emergency to mitigate disruption of clinical studies, including recommendations detailed in the guidance entitled “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency, Guidance for Industry, Investigators, and Institutional Review Boards.” The meeting also featured speakers and panelists from across the clinical trials enterprise, including representatives from Medtronic, the National Cancer Institute (NCI), the National Institutes of Health (NIH), Roche, and many more, who shared the experiences, best practices, and strategies they used to effectively navigate disruptions to clinical studies during the COVID-19 public health emergency.
The meeting fulfilled a requirement under section 3605 of the Food and Drug Omnibus Reform Act of 2022 (FDORA). For more information about this meeting, visit CTTI’s website to view the resources including the final report, the presentation slides and the recording of the meeting.
CTTI and FDA Share Strategies for Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information for Applicable Clinical Trials on ClinicalTrials.gov
Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov allows access to current research and evidence for all partners in the clinical trials enterprise, including patients, providers, sponsors and investigators, regulators, payers, and health system leaders. Despite the regulatory requirements for applicable clinical trials and the importance of fostering transparency while increasing knowledge of potential new treatments in development, multiple publications have reported gaps in clinical trial registration and results information submission to the data bank.
To address this issue, the Clinical Trials Transformation Initiative (CTTI) collaborated with the Food and Drug Administration (FDA) on a project to understand the barriers to timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov. The project involved in-depth interviews and a survey to identify the range of barriers and their salience by type of stakeholder, root causes influencing barriers, and potential solutions and helpful practices to implement moving forward. After the relevant themes were assessed, CTTI surveyed 92 individuals who represented 84 unique organizations and condensed this information into a report containing strategies and recommendations for improving registration and reporting.
Some of the strategies include:
- Use a centralized/dedicated approach to meeting ClinicalTrials.gov requirements
- Take a proactive, rather than reactive, approach to complying with ClinicalTrials.gov regulatory requirements
- Escalate to upper levels of leadership for PIs/study teams that are non-responsive to the administrative unit’s communication about compliance
- Inform PIs/study teams
- about the possibility of civil money penalties for non-compliance with ClinicalTrials.gov regulatory requirements;
- that submitting results information on ClinicalTrials.gov is separate from publishing results; and
- that, per ICMJE, reporting results information on ClinicalTrials.gov does not preclude publishing results in journals
- Provide education, resources, guidance, and support about meeting ClinicalTrials.gov requirements to PIs/study teams and other research personnel
See the full report for a complete list of strategies.
When describing challenges with registering and reporting summary results information from applicable clinical trials, respondents cited several major challenges:
- A lack of understanding on the part of the Principal Investigator (PI) and their study team regarding
- the type of trial that must be registered,
- which trial results must be submitted,
- and when they should be registered.
- Administrative groups also reported challenges relating to non-responsive PIs and study teams, which hinders both timely registering and reporting of results.
- For reporting, PIs and study teams responding to the survey also expressed concerns about waiting until all data are analyzed before reporting results information on ClinicalTrials.gov to prevent discrepancies between ClinicalTrials.gov data and published results.
For more information, see CTTI’s Project page: Challenges Meeting U.S. ClinicalTrials.gov Reporting Requirements.
Patient Engagement Collaborative Announces Eight New Members
Today, the U.S. Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) announced eight newly selected representatives for the Patient Engagement Collaborative (PEC). The group of 16 patients, caregivers, and patient group representatives meets with the FDA several times a year and discusses a variety of topics such as improving communication, education, and patient engagement related to medical product regulation. Those selected to the PEC are expected to serve for two years.
The eight new representatives are:
- Anna Ball
- Kelly Barta
- Ricki Fairley
- Liam McCarthy
- Andrea Meredith
- Patrick Moeschen
- Olga Torres
- Kathryn Washington
The representatives were selected from 75 applications received in response to a Federal Register notice published in July 2023. These new members of the PEC include patients who have personal disease experience, caregivers who have personal experience supporting someone with a health condition, and representatives from patient groups who have direct or indirect disease experience. The selection committee, which included patient advocates, FDA staff from multiple centers, CTTI staff and several outgoing PEC members, worked to identify individuals with diverse perspectives and experiences who could meaningfully contribute and express the patient voice.
“CTTI is thrilled once again to have eight new members of the PEC who will share their insights on patient engagement and research. CTTI’s Transforming Trials 2030 pillars envision a system that representative, accessible, and directly informed by patient preferences and experiences. Having patients as partners, especially through the PEC, is critical to our work. We also wish to thank the outgoing members for their invaluable perspectives during their term,” said Morgan Hanger, CTTI’s Executive Director.
The PEC, a collaboration established by FDA and CTTI in 2018, is a group of patient organizations and individual representatives who discuss ways to enhance patient engagement. FDA and CTTI collaborate to involve representatives with a variety of perspectives including patients, caregivers and representatives from diverse patient organizations and communities. The PEC is run by the FDA’s Patient Affairs, which is dedicated to providing an inviting, welcoming and meaningful experience for patient communities to engage with the FDA.
“Patient community experiences and opinions are essential to inform FDA’s regulatory work. The FDA listens closely to PEC members to integrate different perspectives into meaningful patient engagement and communication opportunities.” said Andrea Furia-Helms, M.P.H., Director of Patient Affairs, Office of Clinical Policy and Programs, FDA.
Going forward, the PEC will continue the dialogue around how patient perspectives can inform the clinical trials enterprise and provide information and resources to enhance PEC members’ knowledge about FDA and CTTI activities to share with patient communities. Previous topics have included: providing enhanced information to patient communities to clarify FDA’s role; updating the PEC Framework; working to better understand COVID-19’s impact on clinical trials; creating new ways to collaborate with patient communities; promoting global collaboration of patient organizations; and enhancing communication between the FDA and patient communities.
The FDA and CTTI wish to thank the outgoing members for their service to the PEC over the past several years:
- Carol Abraham
- Julie Breneiser
- Sneha Dave
- Maria De Leon
- Sharon Lagas
- John Linnell
- James Pantelas
- Traceann Rose
Since 2008, CTTI has included patient advocates on its Executive Committee, Steering Committee, and project teams and, today, nearly all of its more than 30 sets of evidence-based recommendations and associated frameworks and tools mention inclusion of patients as a critical part of the clinical trials process.