By Lindsay McNair, MD, MPH, MSB
Several important ethical topics are currently relevant to the scientific and drug development communities. The role of artificial intelligence in drug development and clinical trials (including the development of protocols and informed consent documents and interaction with research participants), the use of real-world evidence and real-world data in drug development programs, the secondary use of clinical trial data and trial biospecimens, data tokenization, and the ethical issues inherent in conducting clinical trials during times of disruption. All of these subjects were topics of discussion at the Drug Information Association’s (DIA) annual meeting in June.
The Ethics of Conducting Research During Times of Disruption
Prompted by research experiences over the last few years, the session Ethical Considerations for Conducting Research During Times of Disruption was designed to discuss the different factors that sponsors and sites must consider when outside events impact the conduct of clinical trials, including pandemics, natural disasters, and war. This session was chaired by Karla Childers, MSJ, MSBE, Head of Bioethics-based Science and Technology Policy at Johnson & Johnson, and the panelists were Missy Heidelberg, MSBE, Global Bioethics Lead at Takeda, and myself.
We are all aware of the major impact on clinical research caused by the COVID-19 pandemic, but that’s certainly not the only recent example of disruption. More than 800 clinical trials were ongoing in Ukraine at the start of the military conflict in 2022, many of them in oncology, and study sponsors and investigators had to quickly make decisions about what to do, and in a rapidly changing situation.
This session began with a review of some recent examples of research disruption and an overview of the Belmont Principles as the framework for identifying issues to be considered. Through the lens of each principle, the panelists discussed ethical considerations when trying to continue research through major disruptions, and ethical considerations when a decision is made to close a clinical trial site mid-study because of external circumstances.
These situations can be challenging and require balance of the principles. For example, through colleagues in Ukraine and Poland, we heard anecdotes about research nurses who had offered to let study participants stay in their homes so they would not have to leave the country and could remain in the study and could continue to access their study drug regimens. While at first glance this seems like an example of beneficence, in that the nurses were trying to maximize benefits and provide a relatively safe place for participants to live, further consideration makes this more complicated. What if the participants decide they want to withdraw from the clinical trial, but their housing is now tied to trial participation? Would they feel unduly influenced to continue a study they really wanted to leave?
The ethical considerations of stopping the study early were also discussed. While there is published literature on the ethics of stopping studies early, the situations discussed are usually based on studies that meet pre-defined, early stopping rules or studies ending for financial or strategic reasons. In these circumstances, stopping may be more abrupt, but it may still be possible to consider whether participants can be transferred to other study sites, and whether benefits can be maximized by donating unused clinical trials supplies, especially in areas which may be having significant medical emergencies and/or supply chain problems. (See Maintaining Safety While Relocating Ukrainian Clinical Trial Participants for more information.)
The session concluded with a discussion of communication and transparency in emergency situations, and the difficult balance of sharing information as soon as it is available versus waiting to confirm the validity of information before disseminating it. For example, in the early months of the COVID-19 pandemic, information circulated quickly about precautions to take and possible treatments, many of which turned out to be unnecessary or ineffective. Healthcare providers are in a difficult position when they want to wait for data to be confirmed or validated before acting on it, while patients are getting recommendations more quickly from unreliable sources.
As the DIA Bioethics Community continues to develop and mature, we anticipate continuing discussions of the bioethics topics that touch on human participant protections and clinical research ethics.
DIA and PRIM&R have had some early conversations about collaboration on issues of interest to the members of both organizations, and we hope to see those conversations continue.
Founded in 1964 as an effort to increase international collaborations after the thalidomide tragedy, DIA is now a large organization of healthcare professionals, regulatory experts and drug/device development professionals in more than 80 countries. In addition to the main DIA programs and conferences, DIA Communities provide a forum for professionals who are interested in specific topic areas to collaborate, develop best practice guidelines, and share educational resources.
The DIA Bioethics Community was founded in 2021 at the request of members who wanted to be able to participate in discussions about the ethical issues encountered in the drug development process, including issues around research ethics and human participant protections.
Lindsay McNair, MD, MPH, MSB, is the Principal Consultant at Equipoise Consulting. For more information about the DIA Bioethics Community, please contact Co-Chairs Karla Childers at kchilde@ITS.JNJ.com or Lindsay McNair at email@example.com.