On Scarcity and the Value of Clinical Trials image

The American Journal of Bioethics, 2018, Issue 4, Volume 18
Luke Gelinas (Senior Researcher), Holly Fernandez Lynch (Former Executive Director), Barbara E. Bierer, & I. Glenn Cohen (Faculty Director)

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Allocation of scarce goods and resources is a common concern in the health care context, from intensive care unit (ICU) beds, to extracorporeal membrane oxygenation (ECMO) machines, to vaccines, to organs for transplant. Problems raised by scarcity are also a concern in clinical research. Of course, investigators must compete for limited funds from the government, foundations, and elsewhere, while industry sponsors must calibrate their investments in research against their likely returns. But even when funded, researchers can face scarcity.

Jecker and colleagues (2018) present one example that arises when demand for a specific type of experimental intervention—patient-specific active immunotherapy—exceeds the ability to produce it, placing limits on the number of studies that can be conducted. In earlier work, we have considered another example: scarcity of willing and eligible participants to power the research an institution would like to support in a particular clinical area (Gelinas, Lynch, Bierer, and Cohen 2017). Such scarcity may lead to recruitment shortfalls, which in turn may lead to underpowered studies, early trial termination, and failure to produce socially valuable knowledge, exposing participants to risks and burdens potentially without adequate countervailing benefits.

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bioethics clinical research health law policy holly fernandez lynch i. glenn cohen luke gelinas