1. Fabrication and concealment by clinical trial participants Eric G. Devine, Ph.D. Boston University

2. “Professional subjects”  Subjects who participate in multiple clinical trials for the sole purpose of generating income.  Clear evidence of a subculture of subjects who participate in multiple trials 1 and evidence that subjects enroll multiple times in the same trial 2-3.  Some evidence exists of subjects using deceptive practices to qualify for studies including concealing health conditions 4 and discarding medication and claiming to have taken it 5.

3. Need for research on professional subjects Research on professional subjects as a population has primarily focused on understanding the potential risks to subjects, not the risk to the integrity of the research protocols. Study Goal: Provide researchers with a better understanding of the prevalence of deceptive behavior and the types of deception that may be used by a sample of experienced research subjects.

4. Methods  100 subjects were recruited through newsprint and online advertisements  Advertisement sought “experienced research subjects”  Advertisement was placed in publications popular among clinical researchers in Boston: Boston Herald, Boston Globe, Boston Metro, and the volunteers section of Craigslist.

5. Methods

6.  Subjects interviewed about use of deceptive strategies while enrolling in studies  Direct Questions asked about concealing information that would exclude them from the study: “I am going to start by reading a list of types of information that people sometimes withhold – let me know if you have ever done this because you knew it would keep you out of a study:” (1) YES (0) NO Health problems (1) YES (0) NO Mental health problems (1) YES (0) NO Your participation in another study (1) YES (0) NO Use of other prescribed medicines (1) YES (0) NO Recreational drugs (1) YES (0) NO Pending legal issues (1) YES (0) NO Your housing situation (1) YES (0) NO Your use of alcohol (1) YES (0) NO Your family history (1) YES (0) NO Any other information?

7. Methods Direct Questions asked about fabricating information: Have you ever exaggerated the symptoms of your health condition in order to gain entry into a study? Have you ever pretended to have a health problem in order to qualify for a study? Have you ever done intentional harm to yourself in order to qualify for a study? Have you ever given researchers false information about your symptoms that are the primary focus of the study? Have you ever given researchers false information about your health condition getting better when in fact it was not?

8. Results Demographics  Male 58%, Female 42%  55% White, 37% African American  62% were retired, disabled, or unemployed  58% reported a household income below US$30,001  Average studies in last year = 12  69% reported previous experience with medication trials  43% in some other form of therapy  35% in psychotherapy study or counseling study

9. Rates of Concealment Types of Information concealed% subjects Lifetime concealing75% Participation in other study43% Health Problems32% Use of other prescribed medicines28% Recreational drug use20% Mental health problems17% Family history14% Alcohol use12% Pending legal issues7%

10. Rates of Fabrication Types of Fabrication% subjects Lifetime Fabrication33% Exaggerated the symptoms of your health condition in order to gain entry into a study25% Pretended to have a health problem in order to qualify for a study14% Given researchers false information about your symptoms that are the primary focus of the study12% Done intentional harm to yourself in order to qualify for a study4% Tried to enroll in the same study twice using different names or by changing part of your identity3%

11. Other forms of deception Other deception types% subjects Participated in more than one study at the same time64% Received information from other people about screening questions in order to qualify for a study40% Given information to other people about screening questions to help them qualify for a study36% Enrolled in a medication study in which you had no intention of taking the medicine11% Given researchers false information about your health condition getting better when in fact it was not5% Come up with a way to stop taking medication without losing reimbursement from participation in the study4%

12. Strategies for enrollment  Review study criteria clinicaltrials.gov  Share information about telephone screening  Pay a “Research Kingpin” a study payment kickback to get information about the study criteria

13. Study design strategies to reduce professional subject enrollment Advertising strategies Payment strategies Telephone screening strategies Baseline screening strategies Attending to subject motivation Attending to inconsistent study data

14. References 1.Abadie R. The professional guinea pig: Big Pharma and the risky world of human subjects. Durham, NC: Duke University Press, 2010. 2.Boyar D, Goldfarb NM. Preventing overlapping enrollment in clinical studies. J Clin Res Best Pract 2010; 6: 1–4. 3.Shiovitz, T. M., Wilcox, C. S., Gevorgyan, L., & Shawkat, A. (2013). CNS Sites Cooperate to Detect Duplicate Subjects with a Clinical Trial Subject Registry. Innovations in Clinical Neuroscience, 10(2), 17–21. 4.Apseloff G, Swayne JK, Gerber N. Medical histories may be unreliable in screening volunteers for clinical trials. Clin Pharmacol Ther 1996; 60: 353–56. 5.Council for Clinical Research Subject Safety and Data Integrity. Pervasive fraud in the clinical trial world. Video, 2010. http://www.youtube.com/watch?v=m_k-ktAgBBU. Accessed 21 May 2015.