This piece first appeared on the Association of Clinical Research Professionals (ACRP) blog and has been cross-posted here with permission.
Do the high hopes of many that a “silver bullet” treatment for COVID-19 is forthcoming any day now represent a red herring to the public where the complexities of clinical research are concerned?
I ask this question because this is an exciting time to be part of the clinical research profession. Between the print, broadcast, and online media, such terms as “clinical trials,” “human subjects research,” and “experimental medicines” are being said and written enough that I think our profession is having a “teachable moment” with the public.
For me, this presents a tremendous opportunity to further our relationships with clinical care patients and potential trial volunteers. It shines a light on a concept that we should all be getting behind, which is offering clinical research as a treatment option. It also continues what should be an always ongoing discussion in our field about what the Belmont Report has to say about the relationships between a physician and a patient and between a researcher and a subject.
Perhaps now more than ever, we have priceless opportunities to demonstrate our commitment to the education of those needing the option of research in their care by following a modern and informed process. Maybe this isn’t clinical research’s “Eureka! moment,” but it must be close.
I can barely get these thoughts out before I become panicked about the prospect of misrepresented data or expedited approval and the consequences they could have on the integrity of research and on how it is perceived by the public. I think of what happened to Jesse Gelsinger when the factors of failure to report data from primate studies, inadequately trained research staff, and financial conflict of interest combined to set gene therapy back for years and did great harm to the reputation of other forms of research on humans. I think of how the immense scale of tragedies wrought by the use of thalidomide in other countries was for the most part averted in the U.S. when a principled Food and Drug Administration pharmacologist was largely responsible for preventing its approval for marketing here.
These and other examples of research gone wrong have happened in the not so distant past. What is the saying—“If I’m right, no one remembers and if I’m wrong, no one forgets.”
In light of such “lessons learned” from the history of clinical research, could our silver bullet in this moment be educating the public on medical trials and the role volunteers play in them, rather than a specific treatment that will magically make the pandemic go away? In other words, could it be continuing the conversation about how drugs and devices and vaccines come to market?
I dread thinking of how political motivations may be harnessed to provide such a distraction during this health crisis that a rapidly developed treatment for which rigorous data collection and reporting had not occurred could merely be a red herring to the public. The promulgation of “snake oil” levels of hype for products of questionable value and studies of poor design will not serve researchers or their subjects well. We already have the grim reminders of Tuskegee, Willowbrook, Guatemala, and so many other places whose names now convey heartbreak and ethical failures to remind us of our lapses in this regard.
Clinical research professionals must come together and stand tall for the tenets our industry holds dear—collecting data that are unbiased; protecting human subjects through the federal regulations and Good Clinical Practice; recording adverse events, serious adverse events, and reportable events thoroughly; and, as the Belmont Report reminds us, applying the concepts of respect for persons, beneficence, and justice in all our dealings with our volunteers.
Joy Jurnack, RN, CCRC, CIP, FACRP, is a patient/subject advocate working in Research Administration at Wilmington Health Research, and a member of the Board of Trustees of the Academy of Clinical Research Professionals, which oversees the ACRP certification programs.