There is widespread recognition, including among pregnant and lactating people, of the need for better evidence on which to base medical treatment decisions during pregnancy and the post-partum period. Despite this, pregnant and lactating people continue to be left out of clinical trials that test drugs, vaccines, devices, and other medical products for safety and efficacy. Study eligibility criteria routinely exclude both pregnant and lactating individuals, even though the biological bases for exclusion of the two populations differ; the effects of exposure of medicinal products to the fetus at the varying stages of development differ from the effects on the neonate or newborn of medicinal products possibly transferred through breast milk Eligibility often requires negative pregnancy tests prior to enrollment and effective methods of contraception for the duration of the study. Further, people who become pregnant while on an interventional trial protocol are typically withdrawn from further participation. Explanations for this are likely to involve perceived ethical, regulatory, and/or legal considerations, reflecting primarily a concern to avoid harming the developing fetus. In the United States, the regulatory framework requires special protections that must be met before pregnant people may participate in clinical research, including limits on the risks they may be asked to undertake. And there are no federal regulations on the exclusion of or additional safeguards for lactating people, despite their common exclusion. In addition, concerns about potential liability and negative public perception are likely to loom large for sponsors, funders, and investigators, motivating them toward the perceived safer strategy of excluding pregnant people from research in many situations.
At the next Bioethics Collaborative, we will examine ethical issues that bear on determining the proper scope of efforts to further the inclusion of people who are pregnant or lactating in clinical research. Discussion will seek to build on prior workshops and recommendations asking such questions as: Is the current default of excluding pregnant and lactating people from interventional clinical trials justifiable? Do pregnant people have the right to autonomously choose what level of risk is acceptable for themselves and the fetus they carry? How do clinical research entities circumscribe a reasonable range of, and limits on, risk for pregnant people in research, and does this definition align with the views of pregnant and lactating people? Are there alternatives to including pregnant people in clinical trials that can yield the data needed to improve the care of pregnant and lactating people and avoid the well-known problems that arise with seeking to protect groups by excluding them? What are the justice-based implications of placing restrictions on pregnancy? Might requirements for effective contraception, for example, inadvertently function to discourage or even preclude participation from people who are unable to afford contraception? Could these requirements, which are likely to be perceived as burdensome by some, hinder the participation of people of childbearing potential generally and further exacerbate gender inequities in clinical research? We will seek to examine these questions and others on March 8.
Learn how these panelists incorporate participant perspectives to craft patient-facing materials that are accessible, culturally competent, and easy to understand. Collecting feedback enhances engagement, empowers patients, improves communication, and addresses information gaps, paving the way for enriched participant experiences and improved health outcomes.
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:
A final guidance on “Conducting Clinical Trials With Decentralized Elements” (the “DCT Final Guidance”);
A draft guidance on “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (the “DAP Draft Guidance”).
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
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
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.
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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
