The next JTF biannual global meeting has been scheduled for June 6, 2024, from 9:00 to 11:00 AM EDT. Please register here to learn about or present updates and coordinate ongoing activities.
Details: The meeting will include information about a comprehensive training program in Canada based on the JTF Framework and other updates. There will also be a time for open discussion with meeting participants.
Meeting of The Research, Development, and Regulatory Roundtable (R3). Meetings are open to R3 Sponsors. To learn more about how to become an R3 Sponsor, click here.
Topics:
Abstract: Real World Evidence and Emerging Trends in Clinical Trial Subject Recruitment
Real World Evidence
In recent years, real-world evidence (“RWE”) has increasingly been incorporated into product development programs, spurred by greater access to RWE, legislative changes, and significant policy development at FDA. The use of RWE raises novel opportunities, as well as new challenges for regulators, clinical trial sponsors, and the life sciences and healthcare industry to set common standards for RWE to ensure it can be relied upon with confidence in regulatory decision-making.
During 2023, FDA released two draft and three final guidance documents concerning RWE. These included the following:
This session will provide an overview of key concepts from these guidance documents, focusing in particular on how they intersect with FDA’s existing regulations on clinical investigations and how they may change the regulatory landscape. In addition to focusing on these recent FDA guidance documents, the speakers will address the application of other U.S. regulatory regimes to RWE activities, including the Common Rule, the Information Blocking Rule, and HIPAA and other data privacy laws.
Clinical Trial Subject Recruitment Trends
Clinical trial sponsors are increasingly exploring different techniques to attract potential subjects to clinical trials, particularly in the context of rare disease studies for which subjects may be difficult to find. These techniques have included the following:
Each of these techniques raise novel regulatory questions, including concerns about pre-approval promotion, data bias, need for institutional review board review and approval, and data privacy.
This session will analyze these trends and the attendant regulatory considerations for each.
Topic: Meeting of The Research, Development, and Regulatory Roundtable (R3)
This is a meeting of The Research, Development, and Regulatory Roundtable (R3) and is open to sponsors. Click here to learn more about the Research, Development, and Regulatory Roundtable (R3) and how to become a sponsor.
Topic: (1) Laboratory Developed Tests; (2) Patient-directed Materials
Topic: Expanded Access (Compassionate Use) for Drugs and Devices
Abstract:
The MRCT Center of Brigham and Women’s Hospital and Harvard and Ropes & Gray, LLP are pleased to announce the first meeting of the Research, Development, & Regulatory Roundtable (R3) in 2024. This session will focus on issues surrounding regulatory pathways for Expanded Access and/or Compassionate Use of drugs and devices.
While clinical research continues to yield medical advancements, there remain no approved therapies for a multitude of serious and life-threatening disorders. In some instances, however, investigational treatments show promise while being evaluated in clinical studies, prompting both patients and physicians to seek access to those investigational treatments, even though such treatments have yet to clear the relevant regulatory checkpoints to be brought to market. Several major markets around the globe, however, provide pathways for patients to receive these as-yet-unapproved investigational treatments outside the context of a clinical trial. Depending on the specific market in question, these regulatory pathways go by different names and necessitate different requirements for patients and their treating clinicians both before and after gaining access to investigational treatments.
In this session, the speakers will deliver prepared remarks to deconvolute these pathways – the key terminology, the relevant statutory and regulatory language, and the key differences between one program and the next. While the primary foci of the R3 will remain the U.S. and European markets at this session, references to programs in non-U.S. and non-European markets will also be included. As always, this session will occur under Chatham House Rule and attendees are thus encouraged to participate freely in discussions of specific, real-world challenges with our invited experts.
Research, Development, and Regulatory Roundtable (R3) meetings are open to sponsors. To learn more about R3 and how to become a sponsor, click here.
The next JTF biannual global meeting has been scheduled for November 14, 2023 from 9:00 to 11:00 AM EST. Please register here to learn about or present updates and coordinate ongoing activities.
Details: The meeting will include a progress report on the update of the data management and informatics domain, potential amendments to the JTF Framework to accommodate emergency preparedness competencies, utilization of the JTF Framework for workforce development for clinical research, and experience of using the JTF Framework in Canada and Switzerland. There will also be a time for open discussion with meeting participants.
As we celebrate Health Literacy Month , we invite you to join us on October 23, 2023, from 12-1 PM ET to explore actionable strategies to incorporate participant perspectives to craft patient-facing materials that are accessible, culturally competent, and easy to understand — the key tenets of health literacy. This approach enhances engagement, empowers patients, improves communication, and addresses knowledge gaps, paving the way for improved health outcomes and enriched participant experiences.
Click here to register.
Topics: 1) Update on the GDPR, including discussion of the EU/US data privacy framework; 2) Considerations for ensuring accurate clinical trials data
OPEN TO THE PUBLIC
GDPR: This session will involve a panel discussion exploring developments occurring in the past year related to the effect of the European Union’s privacy law, the General Data Protection Regulation (“GDPR”), on clinical research. GDPR was the topic of a one-day meeting held in conjunction with the MRCT Center annual meeting in December 2022, and the intent of this panel is to explore what has changed in the intervening 12-month period. Topics to be addressed will include the Trans-Atlantic Data Privacy Framework, the UK-US Data Bridge, ongoing litigation in the EU regarding the definition of anonymization, and the latest relevant European Data Protection Board guidance. The panel will include representatives from leading life sciences companies who advise on data privacy issues as well as a representative of the U.S. Department of Commerce who worked on the Trans-Atlantic Data Privacy Framework.
Ensuring Integrity of Clinical Trial Data: Clinical trials are most often conducted at sites contracted to perform clinical trials. Historically, trials have most often been sited at organized clinics or hospitals, which have reliable systems of ensuring quality of care and creating and maintaining accurate medical records. Yet in recent years, clinical trials have been sited at stand-alone, for-profit research sites that lack the quality assurance infrastructure of clinics or even physician group practices; and in the wake of COVID, clinical trials have often become “remote” or “decentralized.” This session will explore the challenges in this new clinical trial environment to ensuring accurate recording and retention of data, and whether and how monitoring processes should be revised and enhanced.
This meeting is part of the MRCT Center’s 2023 Annual Meeting in Boston on December 13-14 and is open to all registrants at no cost. Guests are welcome to attend the entire program or individual sessions. While in-person attendance is encouraged, virtual participation is welcome.
Click here to register.
Click here for the full schedule and FAQs.
Challenges in Decentralized Clinical Trials – Open Discussion Forum
The provisions of the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) related to advancing diversity, equity, and inclusion in clinical trial enrollment and promoting clinical trial modernization
