Combatting The Professional Patient Problem In Clinical Trials
Clinical research patients are compensated for their participation in clinical trials. The compensation is based on the burden the trial imposes on the patient and is vetted through an institutional review board, so patients are not overly influenced by financial gain to enroll. Unfortunately, in some therapeutic areas and types of clinical trials, the compensation for enrolling in one or more clinical trials or at multiple research sites is enough to influence patients to join more than one contemporaneously and expose themselves to multiple investigational products or multiple doses of one investigational product. In other cases, patients may participate in several clinical trials but never actually take the investigational product, providing false answers and data just to remain in the trial. These “professional patients” are a growing threat to the safety of patients in clinical research and the data integrity of trials. (Even HBO’s show Vice highlighted professional patients in a season 6 episode called “Lab Rat Nation.”) With increasing pressures to recruit subjects in a timely fashion along with the abundance of social media, research participants have increased the incidence of simultaneously enrolling
The hard costs of a failed clinical trial are easily quantifiable, but there are costs that are much more difficult to quantify such as lost time to market to generate sales of the investigational product and damage to the company’s stock price and investor confidence. Eliminating professional patients should not only be the research sites’ responsibility but also the responsibility of the pharmaceutical or biotech company. Professional patients are becoming more educated on how to enter clinical trials due to social media. And, due to the financial compensation and cost of healthcare, professional patients are very interested in enrolling in clinical trials. Incorporating a proactive prescreening service such as a research subject database is vital to eliminating professional patients from your clinical trial. There needs to be adequate awareness and protection across all phases of clinical trials research from phase 1 through 3 to prevent data quality issues and improve research volunteer safety.
in more than one clinical trial at a time. Many patients do not have the […]
