Focus Area: Current Project
Focus Area: Ethics, Conduct, and Oversight
The MRCT Center Bioethics Collaborative is a neutral forum to foster the discussion of bioethical issues among stakeholders involved in global clinical trials for drug and device development. Meetings bring together individuals from academia, industry, patient groups, ethics committees, and government to share, define, study, and propose ethical frameworks to address issues arising in the context of the design, conduct, and oversight of multi-national clinical trials. The MRCT Center runs the Bioethics Collaborative as a cooperative endeavor that meets three times per year.
A planning committee chooses discussion topics in advance. The MRCT Center then prepares a case statement of the topic to be discussed and circulates the case statement, relevant examples and readings prior to the meetings. The meetings themselves follow modified “Chatham House Rules,” by which commentary will not be attributed to any individual, not to their institutional affiliation. After the meetings, the MRCT Center generates a summary of the issues and discussion for participants. At each meeting, the attendees decide whether and how the summary will be adapted for broader distribution or publication.
The MRCT Center is grateful to the following sponsors of the MRCT Bioethics Collaborative:
- Genentech, Inc.
- Johnson & Johnson
- Merck & Co., Inc.
- Pfizer Inc.
- Takeda Pharmaceuticals International, Inc.
Current status: Active
Impact: Discussion forum for pressing ethical issues in multi-regional clinical trials
- Encourage careful discussion and collective understanding of bioethical issues related to global clinical trials
- Develop approaches to address emerging bioethical issues
- Toolkit: MRCT Center Expanded Access to Investigational Products: A practical Approach for Sponsors, Physicians, and Institutional Review Boards
- NEJM Publication: A Framework for Ethical Payment to Research Participants
- Meeting Summary: Enabling Informed Selection of Clinical Trials: Institution, Provider and Participant Responsibilities
|Date and Topic||Topic Summary||Output/ Next Steps|
|February 2020: Pragmatic Clinical Trials & Real-World Evidence||Pragmatic clinical trials (PCTs) compare or assess interventions in real-world practice settings, hoping to deliver data on effectiveness and safety that more closely resembles clinical care than explanatory clinical trials that focus on demonstrating efficacy in a highly controlled setting. PCTs obscure the distinction between research and clinical care more than traditional randomized control trials (RCTs), which in turn raises novel ethical questions concerning informed consent, data privacy, incidental findings, and other issues.||Meeting Summary forthcoming|
|October 2019: Ethical Challenges in Adaptive and Platform Trials||Adaptive and platform trials may promise greater efficiency and scientific sophistication, but they also raise ethical questions about the principles of informed consent, clinical equipoise, and justice, in addition to practical challenges. Attendees engaged and expanded upon these ethical issues and considered strategies for addressing the theoretical and practical challenges they raise for investigators, sponsors, IRBs, participants, and other stakeholders.||Meeting Summary|
Impact of Mobile Devices & Wearable Technologies on the Design and Conduct of Clinical Research
|The widespread use of mobile smart devices and wearables has the potential to change how clinical research is conceptualized and conducted. Participants’ data may now be leveraged for a variety of health purposes, including the development of remote screening and diagnostic tools, early intervention programs, and the promotion of public health. While these developments can make research participation less burdensome, they also raise ethical and regulatory challenges around acceptable levels of privacy risk, necessary precautions for safeguarding participants’ confidentiality, and the optimal approach to risk mitigation. The promises and potential barriers to integrating mobile devices and wearable technologies in clinical trial workflows was the focus of the May 2, 2019, meeting of the MRCT Center Bioethics Collaborative.||Meeting Summary|
Impact of Social Media on Clinical Trial Integrity
|The use of social media in clinical research carries many potential benefits—for example, it enables the creation of valuable support and communication networks for research participants. However, it also carries potential risks, including the possibility that participants may share information online in ways that permit themselves, other participants, and/or the research team to be unblinded to key aspects of the research data. These potential risks, as well as the practical approaches by which they may be mitigated, were the topic of the January 22nd meeting of the Bioethics Collaborative.||May 2019: Publication in The American Journal of Bioethics: Social Media as an Ethical Tool for Retention in Clinical Trials|
|Apr. 2018 |
Return of Individual Results to Research Participants and Axes of Communication
|The MRCT Center Return of Individual Results Work Group has formulated key principles and recommendations on the return of individual results to research participants from clinical trials in which the participants were enrolled (see above). A number of unanswered questions, however, related to return of individual results to research participants persist. For example, who should communicate urgent results and urgent incidental findings to individual research participants? The lead or site investigators? The referring health care provider? The study sponsors? This meeting explored the pragmatic considerations underlying the return of individual results to research participants and axes of communication.||Meeting Summary|
|Jan. 2018 |
Enabling Informed Selection of Clinical Trials: Institution, Provider and Participant Responsibilities
|Realization of clinical trials’ potential benefits depends largely on successful recruitment of study participants, but significant obstacles to patient recruitment persist. Barriers to clinical trial recruitment are well-studied and include a number of patient-, protocol-, and clinician-related factors, such as perceived complexity of enrollment, lack of resources, and mistrust between patients and providers. The current landscape of clinical trial resources is fragmented, which prevents the informed selection of clinical trials in which to enroll.||Meeting Summary|
|Oct. 2017 |
Recruitment of and Fair Payment to International Research Participants
|Presently, there is no operational framework to guides investigators in designing, and IRBs in evaluating, recruitment methodologies and payment proposals to international research participants. This lack of guidance has been a cause for concern amongst regulators, trialists, advocacy groups, and research participants –especially when conducting clinical trials in low-and middle-income countries (LMICs).||February 2018: Publication in the NEJM: A Framework for Ethical Payment to Research Participants|
Diversity in Clinical Research
|Efficacy and safety of medicines can vary depending on a number of intrinsic and extrinsic factors, such as an individual’s genetic background, ethnicity, lifestyle, and age. In appreciation of these differences and in the interest of generating generalizable knowledge—the participant population enrolled in a clinical trial ought to be representative of the general population. Despite this normative ideal, underrepresentation of gender, sex, ethnic, and racial minorities in clinical trials persists.||October 2017: Establishment of new MRCT Center project: Representation of Diverse Populations in Clinical Trials|
Early Termination of Clinical Trials
|Clinical trials are closed prematurely for a variety of reasons, including for scientifically-driven reasons of efficacy, safety, and futility wherein there is no justification for continuing to enroll participants. The majority of clinical trials, however, terminate early as a result of operational issues—such as inadequate recruitment, commercial product viability, insufficient funding or resources, or de-prioritization by an investigator, institution, or sponsor. The decision to terminate a trial raises complex ethical questions regarding the appropriate communication with and responsibilities owed to participants.||Meeting Summary|
Expanded Access to Investigational Medicines
|The administration of an investigational product via Expanded Access is not meant to answer questions about the product’s safety and effectiveness; rather, it is intended to treat an individual patient with a serious or immediately life-threatening disease or condition for which no satisfactory alternative therapy exists. In the absence of robust guidance for assessing requests for expanded access, physicians and sponsors are left without a critical understanding of the legal, ethical, and financial considerations that ought to influence expanded access determinations.||December 2017: Toolkit MRCT Center Expanded Access to Investigational Products: A practical Approach for Sponsors, Physicians, and Institutional Review Boards|
Project Leadership: Barbara Bierer, Luke Gelinas
Contact Information: email@example.com