ACCP Position Statement: "The Importance of Participant Tracking When Conducting Clinical Pharmacology Drug Trials"

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American College of Clinical Pharmacology

Jan 24, 2023, 08:25 ET

ASHBURN, Va., Jan. 24, 2023 /PRNewswire/ -- The American College of Clinical Pharmacology® (ACCP) published a Position Paper entitled "The Importance of Participant Tracking When Conducting Clinical Pharmacology Drug Trials". This paper brings awareness to the need for improved clinical pharmacology trial tracking and management to optimize the safety of the participants and ensure the continued scientific rigor of the clinical trial process. ACCP strongly recommends the use of research participant databases, registries or independent monitoring organizations to oversee the recruitment and enrollment of participants. As all clinical research trials involve a level of risk, it is the ethical responsibility of Sponsors, Ethical Review Boards and Researchers for these trials to ensure this risk is minimized and participant safety maximized, to the extent possible based on the available data at that time. It is therefore paramount that those participating in the clinical trial fully meet the inclusion and exclusion criteria set forth in the protocol and be truthful regarding previous clinical trial experience during the screening phase of the trial. The cost of participant deception may directly affect the safety of those involved. Additionally, such actions may also compromise the validity of these trials and the future regulatory approval or rejection of the therapy. Enrollment of individuals that do not properly disclose prior clinical trial participation or are purposely deceptive during the screening & enrollment periods can create a complex scenario impacting the identification and accurate reporting of safety events and kinetic and dynamic interactions.

ACCP strongly advocates for the need of a harmonized method or system to track participant enrollment in clinical pharmacology research studies. The use of such a method or system would support the current efforts of clinical researchers to ensure safe participation, help mitigate participant exploitation, prevent abuse of the enrollment process and maximize the scientific integrity of these studies. In the absence of a federally established modality, ACCP recommends the use of independent research subject databases, registries or organizations when conducting these studies to oversee the proper enrollment of its participants. ACCP also stresses the need for improved participant awareness concerning the potential safety risks when volunteers enroll into multiple research studies simultaneously or concurrently.

About ACCP

ACCP is a non-profit association providing accredited Continuing Education, publications and career-enhancing opportunities to clinical pharmacology healthcare professionals.

SOURCE American College of Clinical Pharmacology