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Benefits of Participation in Clinical Trials: An Umbrella Review

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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
    Preventive Medicine Unit, Universitary Hospital Virgen de las Nieves, 18014 Granada, Spain
    Instituto de Investigación Biosanitaria de Granada (IBS.GRANADA), 18012 Granada, Spain)

  • Khalid Saeed Khan

    (Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Granada, 18016 Granada, Spain
    CIBER de Epidemiología y Salud Pública (CIBERESP-Spain), 28029 Madrid, Spain)

  • Aurora Bueno-Cavanillas

    (Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Granada, 18016 Granada, Spain
    Instituto de Investigación Biosanitaria de Granada (IBS.GRANADA), 18012 Granada, Spain
    CIBER de Epidemiología y Salud Pública (CIBERESP-Spain), 28029 Madrid, Spain)

  • Naomi Cano-Ibáñez

    (Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Granada, 18016 Granada, Spain
    Instituto de Investigación Biosanitaria de Granada (IBS.GRANADA), 18012 Granada, Spain
    CIBER de Epidemiología y Salud Pública (CIBERESP-Spain), 28029 Madrid, Spain)

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.

Suggested Citation

  • Amira Bouzalmate-Hajjaj & Paloma Massó Guijarro & Khalid Saeed Khan & Aurora Bueno-Cavanillas & Naomi Cano-Ibáñez, 2022. "Benefits of Participation in Clinical Trials: An Umbrella Review," IJERPH, MDPI, vol. 19(22), pages 1-11, November.
    • Handle: RePEc:gam:jijerp:v:19:y:2022:i:22:p:15368-:d:979144
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    References listed on IDEAS

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    1. Phelps, Emma Elizabeth & Tutton, Elizabeth & Griffin, Xavier & Baird, Janis, 2020. "A mixed-methods systematic review of patients' experience of being invited to participate in surgical randomised controlled trials," Social Science & Medicine, Elsevier, vol. 253(C).
    2. Miguel García-Martín & Carmen Amezcua-Prieto & Bassel H Al Wattar & Jan Stener Jørgensen & Aurora Bueno-Cavanillas & Khalid Saeed Khan, 2020. "Patient and Public Involvement in Sexual and Reproductive Health: Time to Properly Integrate Citizen’s Input into Science," IJERPH, MDPI, vol. 17(21), pages 1-12, October.
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