Strategies To Proactively Detect And Prevent Professional Research Subjects With Verified Clinical Trials Research Subject Database Registry

Clinical trials around the world face challenges from professional research subjects or dual enrollment in clinical trials. One group of subjects that have high rates of participation in clinical research are subjects who enroll in multiple trials for the purpose of generating income through study payments or using clinical trials as medical care. These subjects use methods of deception to qualify for the strict entrance criteria of some studies, including concealing information and fabricating information. Including these subjects in the study can raise the placebo response and adverse events.  While there are many strategies to detect and prevent these duplicate subjects or professional research subjects, only the Verified Clinical Trials global research subject database can reliably find these issues at the time of screening and then continue the protections throughout the entire study.

Recruiting in any clinical trial is challenging and meeting targeted goals of recruitment while selecting the proper subjects is difficult. With multitudes of social advertising, people are more aware of the clinical trials and the benefits to joining them. A significant threat to the data quality and safety of research is sampling from the population of subjects who enroll in multiple clinical trials. These subjects, commonly referred to as “professional subjects,” present a significant risk to the integrity of study designs by providing false information as a strategy for meeting inclusion and exclusion criteria for study enrollment. Very often the subject will provide false information about their disease symptoms or medication compliance just to remain in the study. Subjects who use deception in research can substantially undermine the study design by increasing the sample size needed to detect a treatment effect. The impact of the problem is not widely recognized, and it is unlikely that investigators make sample size assumptions that account for subjects who use deception to gain entry to a study and provide false information while enrolled in the study. In Devine’s article Strategies to exclude subjects who conceal and fabricate information when enrolling in clinical trialsthis is discussed in detail. The is also aware of these issues of professional research subjects.

Verified Clinical Trials (VCT) is the only solution that can be used globally and detect professional research subjects upfront at the time of screening and continue these protections the entire duration of the study.  Verified Clinical Trials will also uncover many other potential protocol violations similarly.