The Professional Research Subject Problem In Clinical Trials

Clinical research patients are compensated for their participation in clinical trials. 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 research subjects” are a growing threat to the safety of patients in clinical research and the data integrity of trials.  These issues highlighted by the NIH.

With ever increasing pressures to recruit subjects in a timely fashion along with the abundance of social media, research participants have increased the incidence of dual enrollment in clinical trials. Many patients do not have the money or insurance to obtain proper medical care and choose to go from study to study for their medical care. There are also circumstances in which a patient innocently enrolls in a clinical trial without understanding the impact to his health. The impact and danger of combining multiple investigational products can be steep. Additionally, the cost of screening and enrolling poor-quality duplicate subjects is significant, especially if the study fails to prove efficacy or if adverse events occur that require the trial to be repeated.

The Need for Proactive Prescreening

Most quality Phase 1 clinical research units have some sort of proactive prescreening approach to enrolling patients and use the Verified Clinical Trials global research subject database system. These sites utilize a research subject database that monitors a subject’s study participation history to ensure safety and data quality.  But the issue of professional research subjects and  is as prevealent in phase 2 and phase 3 clinical trials.  There exists the same incidence of protocol violations and duplicate enrollment in clinical trials.

Conclusion

As described in the article by John Carlos Diaz, 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.