Hastings Center Report, Volume 52, Issue 1, Page 51-58, January/February 2022.

In When Clinical Trials Compete: Prioritizing Study Recruitment, Gelinas et al tackle an important issue—study non-completion—and draw conclusions with which we largely agree. Most importantly, we accept that setting priorities among competing research studies is necessary and should be informed by ethical analysis. We disagree with the conclusion of Gelinas et al that this priority setting should take place at the level of the individual research institution. At a minimum, they should consider other actors who might be better suited for (...) this role instead of—or alongside—the institutions that host research. Our view is motivated by three main considerations. First, research institutions have significant latitude to promote their own interests, and there is reason to suspect that their interests do not closely align with the interests of the public. Thus, asking research institutions to set research priorities may result in the selection of studies with suboptimal social value. Second, a large proportion of clinical trials recruits participants at multiple institutions.1 If each institution sets its own priorities, we can expect discrepancies between the priorities set by partner institutions. These discrepancies may delay and discourage collaborative research projects. Finally, we suspect that a great deal of recruitment competition occurs between, rather than within, research institutions. Setting priorities only at …. (shrink)

Recognising that offers of payment to research participants can serve various purposes—reimbursement, compensation and incentive—helps uncover differences between participants, which can justify differential payment of participants within the same study. Participants with different study-related expenses will need different amounts of reimbursement to be restored to their preparticipation financial baseline. Differential compensation can be acceptable when some research participants commit more time or assume greater burdens than others, or if inter-site differences affect the value of compensation. Finally, it may be permissible (...) to offer differential incentive payments if necessary to advance the goals of a study. We encourage investigators and Institutional Review Boards to think about whether to offer payment, in what amounts and for what purpose, and also to consider whether differential payment can help promote the scientific and ethical goals of clinical research. (shrink)

Volume 19, Issue 6, June 2019, Page 64-66.

After witnessing extraordinary scientific and regulatory efforts to speed development of and access to new COVID-19 interventions, patients facing other serious diseases have begun to ask “where’s...

Regulators rely on clinical trials for drug approval and labeling decisions. Health systems and clinicians rely on the evidence from trials to determine treatment, and patients rely on it to decide which courses of care to undertake. Many of these stakeholders presume that the careful review of individual studies is enough to address the ethical and scientific questions that arise in clinical trials. In what follows, however, we demonstrate that explicit consideration of trial portfolios—series of trials that are interrelated by (...) a common set of objectives—is crucial. the ethical acceptability and evidentiary probity of individual trials can change depending on the characteristics of the portfolios in which they are embedded. Second, how trial portfolios are composed, how well they are coordinated, and how efficiently they use information determines the balance of risks and benefits they present as well as their different prospects for generating socially valuable information; these three factors also raise distinct questions of justice. (shrink)

Volume 20, Issue 9, September 2020, Page 23-25.

Volume 19, Issue 6, June 2019, Page 62-64.

The sudden emergence of the COVID-19 pandemic brought global disruption to every aspect of society including healthcare, supply chain, the economy, and social interaction. Among the many emergent considerations were the safety and public health of the public, patients, essential workers, and healthcare professionals. In certain locations, clinical research was halted—or terminated—in deference to the immediate needs of patient care, and clinical trials focusing on the treatment and prevention of coronavirus infection were prioritized over studies focusing on other diseases. Difficult (...) decisions were made rapidly; flexibility and reconsideration were necessary not only because the intensity and severity of infection varied over time and by locale but also because knowledge of the disease and understanding of its treatment grew. Here we discuss the ethical challenges in decision-making and competing ethical tensions during the pandemic in an effort to advance future preparedness. (shrink)