Are 'Healthy Volunteers' for Clinical Trials Actually Healthy?

Pavankumar Kamat

October 26, 2021

More than a quarter of "healthy volunteers" who underwent screening for participation in a phase 1/2 clinical trial of a COVID-19 vaccine had at least one incidental finding detected. Additionally, a significant proportion of individuals practiced social habits that could be detrimental to their health. The results are from a recent study published in  Clinical and Translational Science .

Researchers conducted a retrospective analysis of data from 1838 healthy volunteers screened for participation in a UK multicentre, phase 1/2 COVID-19 vaccine trial.

A substantial proportion of participants practiced social habits, including excessive alcohol consumption (21%), active smoking (10%) and recreational drug use (11%). Furthermore, only 48% of the individuals had a body mass index within the healthy range.

27.7% of participants screened had at least one incidental finding detected and 3.3% had two or more incidental findings.

Physical examination found incidental findings in 16.9% of participants, bradycardia being the most common (8%). 7% and 5% of participants had systolic and diastolic hypertension, respectively, after repeat testing in the same appointment.

The most common laboratory finding at screening was elevated alanine transaminase, which was identified in 5.9% of participants. Eosinophilia was the most common haematological incidental finding, identified in 1% of the participants. 0.4% of individuals had evidence of a blood-borne virus infection.

The authors stated: "Guidelines for the definition and management of abnormalities identified in healthy participants are needed to ensure an appropriate balance is struck between early identification of medical problems and avoidance of unnecessary investigations."

They also recommend that volunteers should receive counselling prior to the consent process regarding the likelihood of an incidental finding being found on screening and the subsequent measures that will be followed. Any incidental finding should be communicated with the participant and their primary health care provider.

This article originally appeared on Univadis, part of the Medscape Professional Network.

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