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As a clinical research professional, you know that the validity of your clinical trial can be jeopardized by "professional patients", as recent research shows that 75% of trial hoppers hide information or stretch the truth to increase the likelihood that they will be admitted into a study. As a Talent Acquisition Consultant at Veristat (a CRO), I have a vested interest in the struggles that CRAs face and I have found two articles highlighting the dangers that professional patients present in clinical trials.
The first article, written by Barbara Elashoff and titled "Professional Patients and Deception in Clinical Research Trials", appeared in Forbes and reveals the shocking statistics surrounding the number of professional patients who lie in order to be ensure their participation in a study. The article emphasizes that this is especially problematic in trials where the condition being studied cannot be verified subjectively, because you have to take a patient's word about their level of anxiety or physical pain. Elashoff also discloses that some trial hoppers will even purchase the answers needed to pass the screening questions.
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The second article, titled "Professional Guinea Pigs and Big Pharma: An Interview with Roberto Abadie", via Corporations and Health Watch reviews the same issue but focuses on the risks that professional patients place on themselves. Abadie found that some trial hoppers participated in more than 10 trials a year without fully understanding the risk that they were facing. This article also noted that the level of monetary compensation involved determined the extremes that patients would go to in order to be enrolled in the study, which echoed a similar finding from the first article.
Drawing on these two articles, in addition to my experience interacting with CRAs and attending Lunch and Learn sessions at Veristat, I have listed three actions you should take to spot professional patients and increase the validity of your clinical trials:
- Review historical site data - Use an electronic data capture system (EDC) to look at sites in the same geographic areas and spot anomalies such as professional patients.
- Targeted source data verification (SDV) - Targeted SDV verifies clinical trial data (including study endpoints) and can improve regulatory compliance, data quality, and trial validity by spotting professional patients.
- Risk Based Monitoring (RBM) - RBM enables CRAs to target and prioritize resources around specific risks related to the safety of subjects and quality and integrity of clinical data.
Now that you better understand the risks posed to both the patients and the clinical trials, you can begin to make spotting professional patients a priority in your monitoring activities and make a positive impact on the industry.
Robin Brodrick is a Talent Acquisition Consultant at Veristat. (To learn more about Veristat and its open positions, click here). Robin is currently expanding her professional skills by taking the Social Media Marketing Specialization by Northwestern University via Coursera. Follow Robin on Twitter or LinkedIn, and follow Veristat on Twitter or LinkedIn!