Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2022 Nov 21;19(22):15368.
doi: 10.3390/ijerph192215368.

Benefits of Participation in Clinical Trials: An Umbrella Review

Amira Bouzalmate-Hajjaj  1 , Paloma Massó Guijarro  1   2   3 , Khalid Saeed Khan  1   4 , Aurora Bueno-Cavanillas  1   3   4 , Naomi Cano-Ibáñez  1   3   4
Affiliations
Review

Benefits of Participation in Clinical Trials: An Umbrella Review

Amira Bouzalmate-Hajjaj et al. Int J Environ Res Public Health. .

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: health changes; non-participants; participation; randomised controlled trials; systematic reviews; umbrella review.

PubMed Disclaimer

Conflict of interest statement

K.S.K. is the co-author of a systematic review included in this article [29].

Figures

Figure 1
Figure 1
Flow chart of selected reviews and meta-analyses evaluating the benefits of participation in clinical trials.
Figure 2
Figure 2
Quality assessment of the selected reviews and meta-analyses evaluating the benefits of participation in clinical trials using AMSTAR-2 (percentage of systematic reviews meeting the16 items).
Figure 3
Figure 3
Results of the selected reviews and meta-analyses evaluating the benefits of participation in clinical trials.
Figure 4
Figure 4
Results of the selected reviews and meta-analysis evaluating risk of mortality.
See this image and copyright information in PMC

References

    1. Thangaratinam S., Khan K.S. Participation in research as a means of improving quality of care: The role of a principal investigator in multicentre clinical trials. Obstet. Gynaecol. 2015;17:55–61. doi: 10.1111/tog.12157. - DOI
    1. Hellman S., Hellman D.S. Of mice but not men. Problems of the randomized clinical trial. N. Engl. J. Med. 1991;324:1585–1589. doi: 10.1056/NEJM199105303242208. - DOI - PubMed
    1. Clarke M., Loudon K. Effects on patients of their healthcare practitioner’s or institution’s participation in clinical trials: A systematic review. Trials. 2011;12:16. doi: 10.1186/1745-6215-12-16. - DOI - PMC - PubMed
    1. Joosten E.A.G., DeFuentes-Merillas L., de Weert G.H., Sensky T., van der Staak C.P.F., de Jong C.A.J. Systematic review of the effects of shared decision-making on patient satisfaction, treatment adherence and health status. Psychother. Psychosom. 2008;77:219–226. doi: 10.1159/000126073. - DOI - PubMed
    1. Waters L., George A.S., Chey T., Bauman A. Weight change in control group participants in behavioural weight loss interventions: A systematic review and meta-regression study. BMC Med. Res. Methodol. 2012;12:120. doi: 10.1186/1471-2288-12-120. - DOI - PMC - PubMed