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The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence
Open accessAbstract
BACKGROUND: Participation in randomized controlled trials (RCTs) may be quite demanding and could represent an important burden for patients. We aimed to explore this research burden (i.e., the psychological, physical, and financial burdens) experienced by patients through their participation in a RCT. METHODS: We conducted a systematic review of qualitative studies exploring adult patients' experiences with RCT participation. We searched MEDLINE (PubMed), CINAHL, PSYCHINFO, and Embase (search date March 2018) for eligible reports. Qualitative data coding and indexing were assisted by NVivo. The quality of reports was assessed by using the Critical Appraisal Skills Program (CASP) tool. RESULTS: We included 45 qualitative studies that involved 1732 RCT participants. Important psychological burdens were identified at every stage of the trial process. Participants reported feeling anxiety and being afraid of "being a 'guinea pig'" and described undergoing randomization and allocation to a placebo as particularly difficult resulting in disappointment, anger, and depression. Patients' follow-up and trial closure were also responsible for a wide range of psychological, physical, and financial burdens. Furthermore, factors related to burdensome impacts and consequences were discerned. These factors involved trial information, poorly organized and too-demanding follow-up, and lack of appropriate management when the patient's participation ended. Trial participation was also associated with beneficial effects such as the satisfaction of feeling "useful," gaining "a sense of control," and receiving special attention. CONCLUSIONS: Our finding provides a detailed description of research burden across the whole RCT process. Many of the burdens described could be anticipated, and some avoided in a movement toward minimally disruptive clinical research. Such an approach could improve trial recruitment and retention. REVIEW REGISTRATION: PROSPERO CRD42018098994.
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“The feasibility of participant recruitment and retention in RCTs can differ from that in one-group pretest-posttest design studies due to additional psychological burdens in participants that arise from the RCT process, such as a lack of control and anxiety that result from random allocation and disappointment when allocated to a less favorable control group condition”
From The feasibility and preliminary effects of a pilot randomized controlled trial: Videoconferencing acceptance and commitment therapy in distressed family caregivers of people with dementia. (2023) · cites this paper as Naidoo et al., 2020
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“Individuals with the lowest levels of functioning may be the least likely to participate in, or the first to drop out from, clinical trials because participation might be too burdensome [63].”
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Weemering, D. N., Beelen, A., Kliest, T., van Leeuwen, L. A. G., van den Berg, L. H., & van Eijk, R. P. A. (2024) · Neurology · doi:10.1212/wnl.0000000000209503 · Cited by 23
Which Benefits Can Justify Risks in Research?
van Rijssel, T. I., van Thiel, G. J. M. W., Gardarsdóttir, H., van Delden, J. J. M., & on behalf of the Trials@Home consortium (2024) · The American Journal of Bioethics · doi:10.1080/15265161.2023.2296404 · Cited by 22
“By increasing visits to the hospital, participation in a clinical trial adds substantially to the time-and travel burdens and expenses of patients (Naidoo et al. 2020).”
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“Participants also identified positive reinforcement and feedback in research studies as enabling factors, in line with the literature.(12) These findings underscore the need to encourage patients to acknowledge their burdens and communicate what could be done to better support them.”
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“15 Likewise, a recent thematic synthesis of 45 qualitative studies 16 exploring adult patients’ experiences with RCT participation identified the diverse psychological, physical and financial burdens experienced by patients across the whole process of the trial.”
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“These practical issues contribute to the burden experienced when participating in clinical research 26 and are more challenging at short notice.”
A Just Genomics Needs an ELSI of Translation
Halley, M. C., Olson, N. W., Ashley, E. A., Goldenberg, A. J., & Tabor, H. K. (2024) · The Hastings Center Report · doi:10.1002/hast.4938 · Cited by 4
Vorderstrasse, A. A., Reagan, L., Melkus, G. D., Nowlin, S. Y., Birdsall, S. B., Burd, A., Cho, Y. H., Jang, M., & Johnson, C. (2021) · Contemporary Clinical Trials · doi:10.1016/j.cct.2021.106399 · Cited by 4
Knowlson, C. N., Tharmanathan, P., Arundel, C., James, S., Flett, L., Gascoyne, S., Welch, C., Warwick, D. J., & Dias, J. J. (2022) · Research Methods in Medicine & Health Sciences · doi:10.1177/26320843221128296 · Cited by 4
“Additionally this benefits the patients by minimising the time and financial burden of attending hospital appointments, which could improve recruitment and retention.(33) When the first nationwide lockdown was announced in 2020, the initial changes to data collection by post or telephone were straightforward for the D…”
Seery, C., Rushiti, F., Krasniqi, S. P., Çarkaxhiu, S. I., Xhemaili, V. D., Limani, D. A., Prapashtica, Q., Turjaka, V., Zekaj, N., Salihu, M., et al. (2024) · Clinical Psychology & Psychotherapy · doi:10.1002/cpp.3039 · Cited by 3
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Tian, Y., Lu, H., Zhou, W., Doi, S. A. R., Furuya‐Kanamori, L., Lin, L., Loke, Y. K., Vohra, S., Xu, C., & Xu, Z. (2025) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2025.111813 · Cited by 3
Challenges in Cardiomyopathy Gene Therapy Clinical Trial Design
Satish, T., Hong, K. N., Kaski, J. P., & Greenberg, B. H. (2024) · JACC Heart Failure · doi:10.1016/j.jchf.2024.08.024 · Cited by 3
Lucas, P., Boyd, S. C., Milloy, M., & Walsh, Z. (2021) · Journal of Cannabis Research · doi:10.1186/s42238-021-00089-7 · Cited by 3
Garner, J. A., Hanson, K. L., Pitts, S. J., Kolodinsky, J., Sitaker, M., Ammerman, A. S., Kenkel, D., & Seguin‐Fowler, R. A. (2023) · International Journal of Behavioral Nutrition and Physical Activity · doi:10.1186/s12966-023-01481-7 · Cited by 5
“This is especially true given the equity implications of interventions that transfer additional burden onto resource-constrained segments of the population [15, 16].”
BackgroundThe Patient Experience Driver Toolkit: Centering Patients in the Design of New Care Pathways
O’Neill, D., Noortman, R., Burghoorn, A. W., Deckers, E., Wensveen, S. S. A. G., & Birk, M. V. (2025) · International Journal of Human-Computer Interaction · doi:10.1080/10447318.2025.2490400 · Cited by 2
Langerak, A. J., van der Gun, G. J., Meskers, C. G. M., Bussmann, J. B. J., van Wegen, E. E. H., Kwakkel, G., & Selles, R. W. (2025) · Neurorehabilitation and neural repair · doi:10.1177/15459683251369467 · Cited by 2
Xu, C., Doi, S. A. R., Vohra, S., Furuya‐Kanamori, L., Wang, Y., Tang, L., Tian, Y., Fan, S., Peng, Z., Mayo‐Wilson, E., et al. (2026) · BMC Medicine · doi:10.1186/s12916-026-04709-y · Cited by 2
“Randomized controlled trials (RCTs) are used to evaluate medication-related harms [9, 10].”
Planned time burden for patients participating in phase 2 cancer trials
Ouimet, C., Iskander, R., Nipp, R. D., & Kimmelman, J. (2026) · The Oncologist · doi:10.1093/oncolo/oyag096 · Cited by 2
Avilés, N. R., Zapata, J. F., Keuneke, A., Petroff, D., Etz, C. D., & Epstein, D. M. (2022) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2022.100987 · Cited by 2
“For many respondents, it was not simply that they did not fully understand the concepts of a control group or random allocation—they disliked and resisted them [9].”
BackgroundThallner, R., Gumbinger, C., Hohmann, A., Wick, A., Wick, W., & Busetto, L. (2024) · Cancer Management and Research · doi:10.2147/cmar.s447407 · Cited by 2
“15,16 Due to limited therapeutic options, treatment may be considered to take place in an interventional trial.”
BackgroundSeoane, M. C., Jake‐Schoffman, D. E., Mobley, A. R., & McVay, M. A. (2024) · Journal of Immigrant and Minority Health · doi:10.1007/s10903-024-01632-3 · Cited by 2
Thombs, B. D., Adams, C., Nassar, E., Carrier, M., Golberg, M., Bharthi, K., Wurz, A. J., South, A., Kwakkenbos, L., Hoa, S. A.-T., et al. (2025) · Trials · doi:10.1186/s13063-025-08846-2 · Cited by 2
“Many people participate in research, despite burdens involved [1, 2], because of a desire to help others [3], and most participants want to learn results [4–6].”
Fernández, M. J., Velez, M. A., Glenn, B. A., Cummings, A. L., Segarra-Vázquez, B., Gorbatov, S. D., Park, S. J., Shen, C., Lind-Lebuffe, J. P., Unger, J. M., et al. (2025) · The Oncologist · doi:10.1093/oncolo/oyaf313 · Cited by 2
Anticipatory Burden in Adult-Child Caregivers: A Concept Analysis
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Blomberg, H., Kroll, C., & Tarkiainen, L. (2024) · Journal of European Social Policy · doi:10.1177/09589287241284780 · Cited by 2
“On the one hand, trial participation can have bene fi cial effects such as the satisfaction of feeling ‘ useful ’ for future research and being able to make a ‘ worthwhile ’ contribution (Carey et al., 2001; Naidoo et al., 2020).”
InfluentialRix, J., Docherty, S., Breen, A. C., Sewell, P., & Branney, J. (2021) · Health Expectations · doi:10.1111/hex.13304 · Cited by 2
Neurorehabilitation for upper limb recovery after stroke
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“…similarly constructed burden scores and the probability of unfavorable trial outcomes (e.g. screen failure, poor compliance, study withdrawal, lengthy trial durations), all of which can limit the representativeness of a study population and challenge the validity of a study’s findings [2, 18–22].”
McPhee, N., Hughes, D., & Ristevski, E. (2025) · Trials · doi:10.1186/s13063-025-08731-y · Cited by 1
“Consistent with our results, the benefits of clinical trial participation in this study included altruism, satisfaction resulting from feeling “useful”, and the benefit of close monitoring [35].”
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“A systematic review of RCT participation burden found that more frequent questionnaires increased patient workload, where they compared daily versus weekly assessments [51].”
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“Furthermore, their accessibility to the general public may remove barriers associated with clinical interventions or randomized controlled trials (e.g., availability, transportation, trial duration, and restrictive eligibility criteria; Fogel, 2018; Naidoo et al., 2020; Nipp et al., 2019).”
The undue burdens of clinical trial participation: implications for equity, diversity, and inclusion
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“[18] From their systematic review of 45 qualitative studies exploring adult patients’ experiences with randomised controlled trial (RCT) participation, Naidoo et al. [19] identified such hardships across all phases of the clinical trial.”
Shaping the future of clinical trials through strategic foresight
Lee, S., McIntyre, J., Robertson, T., Kallsen, K., Bauer, M., Berardi, R., Boisvert-Huneault, C., Clerisme-Beaty, E. M., Denton, C. P., Fakra, É., et al. (2026) · Clinical Trials · doi:10.1177/17407745251414680 · Cited by 1
“12 While advances in digitalization and artificial intelligence (AI) offer opportunities for clinical trials through data linkage, decentralization and automated data collection, 13–15 the adoption of technology in clinical trials has typically been slow.”
Faiela, C., Moon, T. D., Sidat, M., & Sevene, E. (2026) · Implementation Science Communications · doi:10.1186/s43058-026-00957-4 · Cited by 1
“An increased participation rate in randomized controlled trials can be achieved when participants perceive that they will receive better care and extra attention [33].”
Disclosing the Possibility of Early Trial Termination to Prospective Clinical Trial Participants
Hutchinson, N., Gelinas, L. C., & Bierer, B. E. (2026) · The American Journal of Bioethics · doi:10.1080/15265161.2026.2675905 · Cited by 1
The DCM Project Portal: A direct-to-participant platform of The DCM Research Project
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“S1), and decrease the burden of unnecessary in person visits [24].”
Caring for Patients in an Evidence-Limited World
Ramaswamy, R., & Leipzig, R. M. (2024) · Springer eBooks · doi:10.1007/978-3-030-74720-6_3 · Cited by 1
Kelley, A. T., Incze, M. A., Baumgärtner, M., Campbell, A. N. C., Nunes, E. V., & Scharfstein, D. O. (2024) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2024.111368 · Cited by 1
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Self-citationCaring for Patients in an Evidence-Limited World
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Gu, J., Dunlop, A. D., Donovan, L., & Chaput, K. H. (2025) · medRxiv · doi:10.1101/2025.11.17.25340428 · Cited by 1
“13,14 In addition, qualitative studies do not allow for the generation of quantitative evidence and are challenging to standardise across research practice, which limit the comparability of findings across different studies.”
Borderline microscopic organism and lockdown impacted across the borders—global shakers
Suleman, S., Farooqui, A., Sharma, P., Malhotra, N., Yadav, N., Narang, J., Hasnain, M. S., & Nayak, A. K. (2021) · Environmental Science and Pollution Research · doi:10.1007/s11356-021-17641-w
Metadata
- Authors
- Naidoo, N., Nguyen, V. T., Ravaud, P., Young, B., Amiel, P., Schanté, D., Clarke, M., & Boutron, I.
- Affiliations
- Inserm (FR)
- University of Liverpool (GB)
- Institut National du Cancer (FR)
- Queen's University Belfast (GB)
- Corresponding author
- Boutron, Isabelle
- ORCID
- Venue
- BMC Medicine
- Published
- 2020-01-20
- Volume
- 18
- Issue
- 1
- Pages
- 6-6
- ISSN
- 1741-7015 (ISSN-L)
- PMC
- PMC6970283
- OpenAlex
- W2999900278
- Cited by
- 144
- References
- 53
- Citations by year
- 2026: 27 · 2025: 22 · 2024: 19 · 2023: 18 · 2022: 22 · 2021: 30 · 2020: 6
- FWCI
- 3.18
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- BMC Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- HAL (submittedVersion, cc-by)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Columbia Academic Commons (Columbia University)
- Funders
- Institut National Du Cancer
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Health Sciences › Health Professions › General Health Professions › Mental Health and Patient Involvement
- Keywords
- research burden, randomized controlled trials, patient experience, psychological burden, physical burden, financial burden, trial follow-up, trial closure, randomization, trial recruitment, trial retention
- MeSH terms
- Humans, Volunteers, Randomized Controlled Trials as Topic, Cost of Illness, Qualitative Research
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