Benefits of Participation in Clinical Trials: An Umbrella Review

Amira Bouzalmate-Hajjaj, Paloma Massó Guijarro (), Khalid Saeed Khan, Aurora Bueno-Cavanillas and Naomi Cano-Ibáñez
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Amira Bouzalmate-Hajjaj: Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Granada, 18016 Granada, Spain
Paloma Massó Guijarro: Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Granada, 18016 Granada, Spain
Khalid Saeed Khan: Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Granada, 18016 Granada, Spain
Aurora Bueno-Cavanillas: Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Granada, 18016 Granada, Spain
Naomi Cano-Ibáñez: Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Granada, 18016 Granada, Spain

IJERPH, 2022, vol. 19, issue 22, 1-11

Abstract: Participation in randomised clinical trials (RCTs) entails taking part in the discovery of effects of health care interventions. The question of whether participants’ outcomes are different to those of non-participants remains controversial. This umbrella review was aimed at assessing whether there are health benefits of participation in RCTs, compared to non-participation. After prospective registration (PROSPERO CRD42021287812), we searched the Medline, Scopus, Web of Science and Cochrane Library databases from inception to June 2022 to identify relevant systematic reviews with or without meta-analyses. Data extraction and study quality assessment (AMSTAR-2) were performed by two independent reviewers. Of 914 records, six systematic reviews summarising 380 comparisons of RCT participants with non-participants met the inclusion criteria. In two reviews, the majority of comparisons were in favour of participation in RCTs. Of the total of comparisons, 69 (18.7%) were in favour of participation, reporting statistically significant better outcomes for patients treated within RCTs, 264 (71.7%) comparisons were not statistically significant, and 35 (9.5%) comparisons were in favour of non-participation. None of the reviews found a harmful effect of participation in RCTs. Our findings suggest that taking part in RCTs may be beneficial compared to non-participation.

Keywords: participation; non-participants; systematic reviews; umbrella review; health changes; randomised controlled trials (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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