The MRCT Center and Medable convened a multi-stakeholder task force to address ethical and regulatory opportunities and challenges related to Decentralized Clinical Trials (DCTs). We invite you to join us on June 20, from 10 – 11 AM ET, for a joint webinar entitled, “Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources & Best Practices.”
During the webinar, Barbara Bierer (MRCT Center), Pam Tenaerts (Medable) and Leanne Madre (Medable) will present a framework, recommendations, and tools organized around 3 DCT domains: People, Remote Data Collection, and Data Oversight. Best practices for the ethical review, approval, and conduct of DCTs will be provided.We invite clinical trial stakeholders (IRB/ECs, HRPP, sites, sponsors, investigators, and others) to register for the webinar. Please click on the following link: https://conta.cc/3WzhdT0
Description: We are delighted to announce a collaboration with Clinical Data Interchange Standards Consortium (CDISC) on the MRCT Center Clinical Research Glossary. This marks an important first step in making plain language a global clinical research standard. The MRCT Center Clinical Research Glossary was piloted in 2020 to test the process of creating a plain language glossary of commonly used clinical research terms that is freely available to everyone.
Please join us on April 5 from 11 AM – 12 PM ET for a joint webinar with the MRCT Center and CDISC. Learn about MRCT Center’s robust process of developing the plain language glossary, the CDISC public review, and how this collaboration will empower patients and participants with the necessary tools and information to make informed research decisions.
As more states move to legalize marijuana, the regulatory landscape is becoming increasingly complex. The number of sponsors and researchers inquiring about these regulations has also increased. Clinical research involving cannabis is subject to both federal and state regulations. Key regulatory frameworks include DEA regulations on the use of controlled substances in research studies, FDA IND regulations, and state law. Proposed federal legislation may also affect the conduct of research involving cannabis. David Peloquin, MRCT Center Senior Advisor and Partner at Ropes & Gray LLP, provided an overview of DEA and FDA regulations relating to research involving cannabis, reviewed recent legislative developments, and discussed state-level policies and challenges using New York state as an example.
In an increasingly connected world, clinical trials and other research activities are no longer state- or country-specific. Not surprisingly, the globalization of research activities creates any number of legal and compliance challenges for stakeholders involved in the development, authorization, and commercialization of medicinal products, including under data privacy regulations that continue to evolve.
This hybrid meeting addressed some of the most pressing of these challenges. We addressed issues that go to the heart of the General Data Protection Regulation (“GDPR”) of the European Union (“EU”), such as what constitutes a restricted international data transfer, the appropriate lawful basis to legitimize the processing of personal data in the context of clinical trials and secondary research, and the designations of parties participating in research as controllers and processors. We also discussed potential solutions to problems that continue to challenge the research community. The research community has been awaiting further guidance on the topic of the GDPR and research from the European Data Protection Board (“EDPB”) for several years. The research community must thus navigate several complex issues in the absence of relevant regulatory guidance.
This meeting consisted of a series of panels made up of experts from the life sciences industry, government, and academia to address key challenges faced by the research sector under the GDPR and data privacy regulations in other geographies, including the Personal Information Protection Law of the People’s Republic of China (“PIPL”).
We live in a destabilizing world, where natural disasters, wars, pandemics, and other disruptive events are becoming more common. In clinical research, such disruption is detrimental to research participants and to the advances in scientific knowledge that will benefit future patients. Emergency responses, however, can be fragmented and inefficient. The COVID-19 pandemic has impressed this point on the research community, raising awareness of the need to plan ahead and adapt in response to disaster. To date, most of the attention has focused on actual responses to the pandemic – primarily setting up new, pandemic-focused trials, or calling for changes to clinical trial infrastructure in anticipation of the next pandemic. However, other types of emergencies are often left out of these discussions.
At this meeting of the MRCT Center Bioethics Collaborative, we hope to explore sponsors’ and investigators’ ethical obligations to plan for emergencies in advance. What obligations do they have to participants? How much preparation is necessary? How much is realistic? What obligations do research teams on the ground in disruptive and potentially dangerous situations have to research participants and to maintaining research protocols? Answering these questions and more will allow the clinical research community to develop the guidelines and infrastructure necessary to prepare for future emergency situations.
The MRCT Center is pleased to announce our upcoming webinar, “Promoting Global Clinical Research in Children: Informing the Future,” the conclusion of the five-part virtual conference series on Advancing International Pediatric Clinical Research.
This event will showcase select resources and materials from the pediatric clinical research initiative, including information from previous webinars.
Topic: Gene Therapies: Probing the Ethics (open to all)
There is understandable excitement about the potential for cellular products and gene therapies to transform the therapeutic landscape for many medical conditions. Although a number of cell and gene therapy therapies have already been approved and are available on the market, hundreds more are in various stages of research and development. However, this new class of therapeutics raises distinctive ethical issues that deserve careful consideration. Cell and gene therapies may have a transformative impact on research participants, manifesting not only in extended benefit but also in the need for additional safety monitoring far beyond what is typical in clinical research. Further, individuals can generally participate in only one of several clinical trials investigating possible treatments for the same condition and may need to forego alternative treatments that are developed in the future. Finally, there are issues of access to these experimental therapies. These features of cell and gene therapies can raise the stakes, making questions about how to apply traditional bioethical principles of autonomy, beneficence, non-maleficence, and justice more challenging. How can researchers and developers of cell and gene therapies design trials with due consideration for the distinct ethical issues raised by these therapies? Given the significance of the choice to receive cell and gene therapies and how this may impact and/or limit future options, what are best practices for the informed consent process? What key information should be disclosed to potential participants and caregivers and what measures should be taken to ensure comprehension? How does the acuity, instability, and chronicity of the disease impact these decisions? In this session, we will consider these ethical issues and others, assessing them in light of the need for scientifically robust research on cell and gene therapies while striving to do justice to research participants, patients, and their families.
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.
In recent years, the use of artificial intelligence (AI) has steadily increased across many industries, including clinical research. The November 2022 release of OpenAI’s ChatGPT – a large language model that generates human-like output text in response to text input—has generated unprecedented public interest in the capabilities and potential impact of AI. Although there has been robust discussion of the use of AI in medicine, the applications of AI in clinical research, and the attendant ethical issues they raise have been relatively under-explored. The October 10, 2023, meeting of the Bioethics Collaborative will aim to clarify the current and potential uses of AI in clinical research, identify salient ethical challenges and issues, and provoke deliberation on how best to approach the development of ethical frameworks that can guide the development and use of AI in clinical research.
Research ethics since the Belmont Report has rested on the assumption that there is an ethically important distinction between clinical research and clinical care. This distinction has provided the foundation for analyses of numerous bioethical concepts, including clinical equipoise, the researcher-participant relationship, and therapeutic misconception, among many others. However, the lines between research and care are increasingly blurred, due to such developments as embedded pragmatic trials, decentralized research designs, expanded access programs, and increased appreciation of the situations in which no standard of care options exist for patients. We will assess what this blurring means for the research/care distinction and whether it should prompt us to reconsider its import.
N-of-1 trials share a common feature: they are single-subject study designs with the goal of determining how an individual patient responds to treatment intervention(s). These trials can take several forms, spanning different purposes and study populations, with their own distinctive advantages and challenges. The April 2023 Bioethics Collaborative focused on various ethical questions that arise in N-of-1 research: How do traditional research ethics principles and analyses, such as the concept of clinical equipoise and ‘social value,’ apply to N-of-1 research? How can the N-of-1 approach be generalized if each “trial” is unique to the individual? Is there a way to gain generalizable knowledge across several individual trials? How should costly N-of-1 research be prioritized against other research priorities? How do we decide, fairly and equitably, who has access to N-of-1 trials, particularly for rare or unique genetic conditions? How should we think about informed consent and make efforts to support it, given the potentially transformative nature of personalized interventions in particular?
