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Conversation about Dubious Stem Cell Clinical Trials Marketed on NIH Website

A couple of days ago, I spoke with reporter Bradley J. Fikes about an interesting,ClincialTrials.gov homepage new study “ClinicalTrials.gov, stem cells and ‘pay-to-participate’ clinical studies” (by Leigh Turner, an associate professor at the University of Minnesota Center for Bioethics). The paper describes how businesses use the public website ClinicalTrials.gov to recruit participants for unapproved stem cell interventions. This is an interesting use-case that highlights the challenges of the Internet, clinical trial recruitment and research ethics.

ClinicalTrials.gov serves as a registry and results database of publicly and privately supported clinical studies conducted around the world. The site was launched in 2000 by the National Institutes of Health (NIH) and the Department of Health and Human Services, through its National Library of Medicine. The information in the registry was intended for a wide audience, including individuals with serious or life-threatening diseases or conditions, members of the public, health care providers, and researchers. One of the main barriers to successful clinical trials and clinical study participation is the lack of awareness that trials are taking place. The problem is that the success and usefulness of ClinicalTrials.gov ultimately depends on whether investigators and sponsors submit complete, timely, accurate, and informative data about their studies. Turner describes the problem as a lack of quality control and oversight. He provides food for thought as to what steps could be taken to prevent wrongful use of the site and concludes that the database needs better screening tools, for example to identify trials with approval from the Food and Drug Administration (where required) and Institutional Review Board (IRB).

In light of limited resources, I don’t think that it is realistic to ask the NIH to step up its controls for accuracy, validity, and relevance checks. However, by restricting Clinical trials.gov to trials for which clinical research teams provide FDA and IRB approval — as Turner suggests –, the registry could help to accelerate access for patients to well-regulated and adequately funded clinical trials, and the website could exercise its influence to discourage promotion of unproven stem cell interventions outside of approved clinical trials. A technical solution that leverages natural language processing and other forms of machine learning to detect lack of approval could be interesting.

Read the full article by Bradley Fikes published in The San Diego Union-Tribune



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