Overcoming the Clinical Trial Challenges Faced as a Result of Volunteer Shortages and Absences Volume 3 - Issue 2

Michael Downes*

• James Cook University, 1 James Cook Drive, Douglas, Townsville, Australia

Received:September 13, 2022;   Published:September 15, 2022

Corresponding author:Michael Downes, James Cook University, 1 James Cook Drive, Douglas, Townsville, Queensland 4814, Australia

DOI: 10.32474/LOJPCR.2022.03.000156

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Abstract

The increasing monkeypox pandemic has raised many challenges for ongoing clinical trials. These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory testing. Thus, study drug interruptions to clinical trial procedures could be less common and shorter in duration and missed results from patient attendances could be more common. These difficulties were investigated by [1] using 18 ongoing trials. The intent of these analyses has always been to determine whether there were any important imbalances between treatment groups favoring a study drug, and treatment groups omitted from the clinical trials due to active symptoms, hence whether the results could be suggestive of a causal relationship [2]. Because they lack a control arm, events associated with COVID-19 (e.g., fever, cough) or events associated with physical/social isolation or economic hardships might appear at a more frequent rate.

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