Joint Task Force for Clinical Trial Competency (JTF) Biannual Global Meeting

May 16, 2022 @ 9:00 am 1:00 pm

Virtual Event

Details: The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, is dedicated to developing and disseminating standards and practices for the clinical research workforce. The JTF fosters a cohesive, global approach to ensuring that professionals have the necessary competencies to conduct clinical trials effectively and ethically.

The public is invited to attend virtual biannual meetings, which happen twice a year.

Key topics discussed at this meeting:

  • Duke University’s Workforce Engagement and Resilience Program
  • Community of Practice & JTF Competency Framework: 
  • The Research Professionals Network Workshops 
  • Developing Team Sciences Competencies for Clinical Research Professionals
  • Accreditation of Academic Programs in Clinical Research
  • Promotion of the JTF Core Competency Framework in Asia and Africa
  • Deploying the JTF Framework across the world:  Translations and Applications
  • JTF Envisioning the Future

Joint Task Force for Clinical Trial Competency (JTF) Biannual Global Meeting

November 14, 2022 @ 9:00 am 11:00 am

Virtual Event

Details: The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, is dedicated to developing and disseminating standards and practices for the clinical research workforce. The JTF fosters a cohesive, global approach to ensuring that professionals have the necessary competencies to conduct clinical trials effectively and ethically.

The public is invited to attend virtual biannual meetings, which happen twice a year.

Key topics discussed at this meeting:

  • Integrating JTF Framework into Takeda’s R&D’s Knowledge Development Academy (KDA)
  • Update on Translations
  • JTF Competency Survey in Low and Middle Income Countries: Initial Analysis of Results
  • Clinical Research Core Competencies: An Adaptation of the JTF Framework to Switzerland
  • Update from CIOMS

Joint Task Force for Clinical Trial Competency (JTF) Biannual Global Meeting

May 2, 2023 @ 9:00 am 11:00 am

Virtual Event

Details: The Joint Task Force for Clinical Trial Competency (JTF) meets twice a year, and open to the public.

Key topics discussed at this meeting:

  • Use of the JTF Framework in Rutgers University’s MS in Clinical Research Management Program
  • The JTF Framework and Clinical Development Teams in the Biopharmaceutical Industry:  Harnessing innovation in data sciences
  • Integration of the JTF framework as part of the 3CTN’s grant objectives and its utilization at the Odette Cancer Centre inToronto, Canada
  • Updates to the Arabic translation of the JTF Core Competency Framework
  • Adapting the JTF Framework to Non-interventional Clinical Research
  • Collaborations on Implementing the JTF Framework in China

Action and Influence: Implementing the Clinical Research Glossary and Your Critical Role in Public Review

June 4, 2024 @ 11:00 am 12:00 pm

virtual

Presented on: June 4, 2024

Learn how four organizations, Mass General Brigham (MGB) Rally, HonorHealth, the Society for Clinical Data Management (SCDM), and the CureMito Foundation, are implementing the MRCT Center’s Clinical Research Glossary and how you can participate in Public Review, a vital process to ensure the glossary is a CDISC global standard.

Related Resources

Webinar Biobook
The Clinical Research Glossary: Learn More
The Clinical Research Glossary: Working Group
Implementing the Clinical Research Glossary: How to Attribute the MRCT Center
On-Demand Webinar: The Clinical Research Glossary: New Words, New Opportunities
On-Demand Webinar: A Global Standard for Plain Language in Clinical Research: an MRCT Center and CDISC Collaboration

Joint Task Force for Clinical Trial Competency (JTF) Biannual Global Meeting

June 6, 2024 @ 9:00 am 11:00 am

Virtual Event

Details: The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, is dedicated to developing and disseminating standards and practices for the clinical research workforce. The JTF fosters a cohesive, global approach to ensuring that professionals have the necessary competencies to conduct clinical trials effectively and ethically.

The public is invited to attend virtual biannual meetings, which happen twice a year.

Meeting Details: The meeting included 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.

Key Topics:

  • Cantrain: The Canadian Consortium of Clinical Trial Training
  • CIOMS Update
  • Updates:  Deploying the JTF Framework around the World: Arabic Translation
  • 3CTN Updates
  • How a competency-based program will contribute to early clinical research professionals’ training

Real World Evidence (RWE) and Emerging Trends in Clinical Trial Subject Recruitment

May 3, 2024 @ 1:30 pm 4:00 pm

Hybrid: In-person (Boston) and Virtual (Zoom)

800 Boylston St.
Boston, MA 02199

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:

  • Recent Developments in FDA Guidance on Real World Evidence
  • Subject-Directed Recruitment Materials and Testimonials

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:

  •  Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (Draft, February 2023)
  • Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products (Final, August 2023)
  • Use of Real-World Evidence to Support Regulatory Decision-Marking for Medical Devices (Draft, December 2023)
  • Data Standards for Drug and Biological Product Submissions Containing Real World Data (Final, December 2023)
  • Real-World Data:  Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products (Final, December 2023) 

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:

  •  Use of testimonials featuring active clinical trial subjects in clinical trial advertisements
  •  Inclusion of detailed scientific information gathered in pre-clinical or Phase 1 studies in subject-directed recruitment materials
  • Partnerships with electronic health record vendors to identify potential trial sites or subjects

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.

Recent FDA Guidance Documents on Clinical Trials: Decentralized Clinical Trials, Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice, Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs, and Diversity Action Plans

January 9, 2025 @ 1:00 pm 3:30 pm

Hybrid: In-person (Boston) and Virtual (Zoom)

800 Boylston St.
Boston, MA 02199

Description: The FDA has recently issued several guidance documents as part of the Agency’s ongoing efforts to modernize its policies for the conduct of clinical trials.  These include:

During this R3 session, we will provide an overview of each of these guidance documents, discuss thematic intersections between them, and address practical implications for study sponsors, investigators and sites.  With respect to the DCT Final Guidance, we will also look at how the final guidance addressed the MRCT Center’s extensive comments on the draft guidance.


This meeting is open to sponsors of the Research, Development, & Regulatory Roundtable. To learn about how to become a sponsor, please contact us at mrct@bwh.harvard.edu

(1) Laboratory Developed Tests; (2) Limitations on Sharing Data with China and Other Countries of Concern

October 10, 2024 @ 1:00 pm 3:30 pm

Hybrid: In-person (Boston) and Virtual (Zoom)

800 Boylston St.
Boston, MA 02199

Abstract:

Laboratory Developed Tests

The scope of FDA’s authority over laboratory-developed tests (“LDTs”) has long been a source of controversy and debate among government and industry stakeholders. In May 2024, FDA issued a final rule that affirms FDA’s position that LDTs are in vitro diagnostic products (“IVDs”) regulated as medical devices under the Federal Food, Drug, and Cosmetic Act (“FDCA”). In conjunction with this rule, FDA intends to phase out the enforcement discretion policy it has historically applied to most LDTs. This session will summarize the FDA’s final rule and phaseout policy, analyze the impact on clinical research (including the use of LDTs in pharmaceutical trials), and assess the prospects for ongoing litigation challenging FDA’s rule and potential LDT-related legislation from Congress.

Limitations on Sharing Data with China and Other Countries of Concern

Over the past several months there have been significant U.S. executive and congressional actions related to restricting transactions, data transfers, and certain types of contracts with China, other countries of concern (e.g., Russia), and individuals and businesses connected with these countries. Principally, this includes the enactment in April 2024 of the Protecting Americans’ Data from Foreign Adversaries Act, President Biden’s Executive Order on bulk sensitive personal data transfers and the accompanying U.S. Department of Justice rulemaking activities, and the continued consideration by Congress of the BIOSECURE Act. In this session, we will walk through these different pieces of legislation and proposed regulations, focusing on the implications they each may hold for the clinical research enterprise.

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) Limitations on Sharing Data with China and Other Countries of Concern

Expanded Access (Compassionate Use) for Drugs and Devices

March 22, 2024 @ 9:00 am 11:30 am

Hybrid: In-person (Boston) and Virtual (Zoom)

800 Boylston St.
Boston, MA 02199

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.

Joint Task Force for Clinical Trial Competency (JTF) Biannual Global Meeting

November 14, 2023 @ 9:00 am 11:00 am

Virtual Event

The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, is dedicated to developing and disseminating standards and practices for the clinical research workforce. The JTF fosters a cohesive, global approach to ensuring that professionals have the necessary competencies to conduct clinical trials effectively and ethically.

The public is invited to attend virtual biannual meetings, which happen twice a year.

Details: The meeting included 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.

Key Topics:

• Data Management Quick Update: Results from Delphi

• Workforce Development for Clinical Research

• Emergency Preparedness: Proposed Rapid Response Appendix

• Competencies for non-interventional research projects in the Swiss regulatory context

• Update on the use of the JTF framework in Canada under 3CTN

• Update on the Arabic translation

Deliverables