Quantifying Participant Burden In Clinical Trials: Data From Prostate Cancer Rcts

Abstract Background: The restrictions implemented due to the COVID pandemic have underscored the importance of clinical research and trial methodology, while also highlighting the potential need for reduced clinical visits or face to face interaction. This has reignited the discussion surrounding the impact of clinical research participation on trial participants. The primary aim of this study was to quantify participant burden in a sample of prostate cancer clinical trials. Secondary to this was establishing the effect of participant burden on recruitment and retention. Methods: We identified a body of prostate cancer clinical trials in a five-year period from 2017-2021 and randomly selected 30 for inclusion. We categorised participant burden as physical, psychological, economic, familial and societal. We created a measurement tool called the Trial Burden Score and applied it to each included trial. We used the trial burden score to categorise each trial into high participant burden, medium participant burden and low participant burden. We compared the trial burden to recruitment and retention rates in each trial.Results: 50% (n = 15) of the included trials were categorized as high participant burden, 47% (n = 14) as medium participant burden and one trial was categorized as low participant burden. The median participant burden score for each category was: physical burden 11 (range 8-16); psychological burden 14 range (11-18); economic burden 5 (range 2-6); familial burden 10 (range6-11); societal burden 0 (range 0-1). There was no association between stage of cancer diagnosis and the participant burden categories (low, medium, high). There was no correlation between trial burden score and under recruitment percentage and trial burden score and retention. Conclusions: The burden placed on clinical trials participants is significant and requires consideration at the trial design stage. Serious thought should be given to only collecting data necessary to answer the research question while also ensuring the trial is applicable to the population it purports to serve. Limiting burden to improve participant trial experience is vital to ensure our participants have a positive experience, stay in the trial, pass on this positivity to others and are willing to participate in further trials.