The Patient in Your Alzheimer’s Disease Study May be in Another: Duplication and Deception in Clinical Trials of Alzheimer’s Disease

Abstract

Duplicate and deceptive subjects, a significant issue in CNS studies, are not often considered in Alzheimer’s Disease (AD) clinical trials. However, AD patients and their study partners may be motivated to take advantage of different mechanisms of action, increase odds of receiving active treatment, and/or obtain financial compensation, which may lead them to participate in multiple studies. CTSdatabase reviewed memory loss subjects (n=1087) from January 2017 through May 2019 to determine how many attempted to screen at multiple sites. 117 subjects (10.8%) visited more than one site within two years. When these potential AD subjects went to additional sites, it was predominantly for non-memory indications (often MDD or schizophrenia). For those that participated in studies, the rate of duplication approached 4% of screened AD subjects. This data indicates that significant numbers of AD subjects attempt to enroll at multiple sites, which confounds efficacy and safety signals in clinical trials.

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Funding

Funding: There is no outside funding for this report. Ms. Steinmiller, Ms. Steinmetz and Ms. Perez are employees of CTSdatabase, LLC.

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Correspondence to Thomas Shiovitz.

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Conflict of interest disclosure: Dr. Shiovitz has ownership interest in and is President of CTSdatabase, LLC.

Ethical standards: All data reported in this study has been collected from patients who have signed an appropriate IRB or Ethics Committee approved consent form.

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Shiovitz, T., Steinmiller, B., Steinmetz, C. et al. The Patient in Your Alzheimer’s Disease Study May be in Another: Duplication and Deception in Clinical Trials of Alzheimer’s Disease. J Prev Alzheimers Dis 7, 43–46 (2020). https://doi.org/10.14283/jpad.2020.3

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Key words

  • Professional research subject
  • deception
  • duplicate subjects
  • dual enrollment