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.
“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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Cites
Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA statement
Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., & for the PRISMA Group (2009) · BMJ · doi:10.1136/bmj.b2535 · Cited by 83,823 · see citing works
Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement
Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., & The PRISMA Group (2009) · PLoS Medicine · doi:10.1371/journal.pmed.1000097 · Cited by 64,042 · cited 1× · see citing works
“To ensure transparency, we adhered to the reporting guidelines set out by PRISMA [10] and ENTREQ (Additional file 1) [11].”
Preferred reporting items for systematic reviews and meta-analyses: the PRISMA Statement.
(2009) · PubMed Central · Cited by 44,859 · see citing works
Methods for the thematic synthesis of qualitative research in systematic reviews
Thomas, J., & Harden, A. (2008) · BMC Medical Research Methodology · doi:10.1186/1471-2288-8-45 · Cited by 9,312 · see citing works
Enhancing transparency in reporting the synthesis of qualitative research: ENTREQ
Tong, A., Flemming, K., McInnes, E., Oliver, S., & Craig, J. (2012) · BMC Medical Research Methodology · doi:10.1186/1471-2288-12-181 · Cited by 3,569 · see citing works
Qualitative Research: Rigour and qualitative research
Mays, N., & Pope, C. (1995) · BMJ · doi:10.1136/bmj.311.6997.109 · Cited by 2,715 · see citing works
Methley, A. M., Campbell, S., Chew-Graham, C., McNally, R., & Cheraghi-Sohi, S. (2014) · BMC Health Services Research · doi:10.1186/s12913-014-0579-0 · Cited by 2,706 · see citing works
External validity of randomised controlled trials: “To whom do the results of this trial apply?”
Rothwell, P. M. (2005) · The Lancet · doi:10.1016/s0140-6736(04)17670-8 · Cited by 2,544 · see citing works
Chlebowski, R. T., Hendrix, S. L., Langer, R. D., Stefanick, M. L., Gass, M. L. S., Lane, D. S., Rodabough, R. J., Gilligan, M. A., Cyr, M. G., Thomson, C. A., et al. (2003) · JAMA · doi:10.1001/jama.289.24.3243 · Cited by 1,871 · see citing works
Patient engagement in research: a systematic review
Domecq, J. P., Prutsky, G., Elraiyah, T., Wang, Z., Nabhan, M., Shippee, N., Brito, J. P., Boehmer, K., Hasan, R., Firwana, B., et al. (2014) · BMC Health Services Research · doi:10.1186/1472-6963-14-89 · Cited by 1,773 · see citing works
McDonald, A. M., Knight, R. C., Campbell, M. K., Entwistle, V. A., Grant, A. M., Cook, J. A., Elbourne, D. R., Francis, D., Garcia, J., Roberts, I., et al. (2006) · Trials · doi:10.1186/1745-6215-7-9 · Cited by 946 · see citing works
Barriers to Participation in Randomised Controlled Trials
Ross, S., Grant, A., Counsell, C., Gillespie, W., Russell, I., & Prescott, R. (1999) · Journal of Clinical Epidemiology · doi:10.1016/s0895-4356(99)00141-9 · Cited by 907 · see citing works
Systematic Review of Barriers to the Recruitment of Older Patients With Cancer Onto Clinical Trials
Townsley, C. A., Selby, R., & Siu, L. L. (2005) · Journal of Clinical Oncology · doi:10.1200/jco.2005.00.141 · Cited by 587 · see citing works
Booth, A. (2016) · Systematic Reviews · doi:10.1186/s13643-016-0249-x · Cited by 587 · see citing works
Influence of trial sample size on treatment effect estimates: meta-epidemiological study
Dechartres, A., Trinquart, L., Boutron, I., & Ravaud, P. (2013) · BMJ · doi:10.1136/bmj.f2304 · Cited by 544 · see citing works
Self-citationMills, E. J., Seely, D., Rachlis, B., Griffith, L. E., Wu, P., Wilson, K. R., Ellis, P., & Wright, J. R. (2006) · The Lancet Oncology · doi:10.1016/s1470-2045(06)70576-9 · Cited by 536 · see citing works
Strategies to improve recruitment to randomised trials
Treweek, S., Pitkethly, M., Cook, J., Fraser, C., Mitchell, E., Sullivan, F., Jackson, C., Taskila, T. K., & Gardner, H. (2018) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.mr000013.pub6 · Cited by 521 · cited 2× · see citing works
“To our knowledge, there are systematic reviews of qualitative studies to identify barriers and facilitators to recruitment and retention in RCTs [5 – 7]; however, no review yet has specifically explored patients ’ research burden.”
Relton, C., Torgerson, D. J., O’Cathain, A., & Nicholl, J. P. (2010) · BMJ · doi:10.1136/bmj.c1066 · Cited by 519 · see citing works
Noyes, J., Booth, A., Flemming, K., Garside, R., Harden, A., Lewin, S., Pantoja, T., Hannes, K., Cargo, M., & Thomas, J. (2018) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.06.020 · Cited by 480 · see citing works
The experiential knowledge of patients: a new resource for biomedical research?
Caron-Flinterman, J. F., Broerse, J. E. W., & Bunders, J. (2004) · Social Science & Medicine · doi:10.1016/j.socscimed.2004.11.023 · Cited by 388 · see citing works
Fletcher, B., Gheorghe, A., Moore, D., Wilson, S., & Damery, S. L. (2012) · BMJ Open · doi:10.1136/bmjopen-2011-000496 · Cited by 355 · see citing works
The humanization of healthcare: A value framework for qualitative research
Todres, L., Galvin, K., & Holloway, I. (2009) · International Journal of Qualitative Studies on Health and Well-Being · doi:10.1080/17482620802646204 · Cited by 346 · see citing works
Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?
Treweek, S. P., Bevan, S., Bower, P., Campbell, M., Christie, J., Clarke, M. J., Collett, C., Cotton, S. C., Devane, D., Elfeky, A., et al. (2018) · Trials · doi:10.1186/s13063-018-2535-5 · Cited by 298 · see citing works
Self-citationFinding qualitative research: an evaluation of search strategies
Shaw, R. L., Booth, A., Sutton, A. J., Miller, T., Smith, J. A., Young, B., Jones, D. R. H., & Dixon‐Woods, M. (2004) · BMC Medical Research Methodology · doi:10.1186/1471-2288-4-5 · Cited by 295 · see citing works
Self-citationStrategies to improve retention in randomised trials
Brueton, V. C., Tierney, J., Stenning, S., Harding, S., Meredith, S., Nazareth, I., & Rait, G. (2013) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.mr000032.pub2 · Cited by 279 · cited 1× · see citing works
“Such strategies might be implemented and evaluated in a Study Within A Trial (SWAT) [42] and thereby add to the evidence base on recruitment and retention in trials [5, 6].”
BackgroundPatient and public involvement in the design of clinical trials: An overview of systematic reviews
Price, A., Albarqouni, L., Kirkpatrick, J., Clarke, M., Liew, S. M., Roberts, N., & Burls, A. (2018) · Journal of Evaluation in Clinical Practice · doi:10.1111/jep.12805 · Cited by 234 · see citing works
Self-citationHow to assess the external validity of therapeutic trials: a conceptual approach
Dekkers, O. M., Elm, E. V., Algra, A., Romijn, J. A., & Vandenbroucke, J. P. (2010) · International Journal of Epidemiology · doi:10.1093/ije/dyp174 · Cited by 219 · see citing works
Gross, C. P., Mallory, R. M., Heiat, A., & Krumholz, H. M. (2002) · Annals of Internal Medicine · doi:10.7326/0003-4819-137-1-200207020-00007 · Cited by 186 · see citing works
Fully informed consent can be needlessly cruel.
Tobias, J. S., & Souhami, R. L. (1993) · BMJ · doi:10.1136/bmj.307.6913.1199 · Cited by 181 · see citing works
Database searches for qualitative research.
Evans, D. J. (2002) · Europe PMC (PubMed Central) · Cited by 179 · see citing works
A review of reporting of participant recruitment and retention in RCTs in six major journals
Toerien, M., Brookes, S. T., Metcalfe, C., de Salis, I. O. C., Tomlin, Z., Peters, T. J., Sterne, J. A. C., & Donovan, J. (2009) · Trials · doi:10.1186/1745-6215-10-52 · Cited by 175 · see citing works
(2002) · Annals of Internal Medicine · doi:10.7326/0003-4819-137-1-200207020-00002 · Cited by 172 · see citing works
Harris, J. L., Booth, A., Cargo, M., Hannes, K., Harden, A., Flemming, K., Garside, R., Pantoja, T., Thomas, J., & Noyes, J. (2018) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.10.023 · Cited by 165 · see citing works
Healy, P., Galvin, S., Williamson, P. R., Treweek, S. P., Whiting, C., Maeso, B., Bray, C., Brocklehurst, P., Moloney, M. C., Douiri, A., et al. (2018) · Trials · doi:10.1186/s13063-018-2544-4 · Cited by 156 · see citing works
Self-citationRolfe, D. E., Ramsden, V. R., Banner, D., & Graham, I. D. (2018) · Research Involvement and Engagement · doi:10.1186/s40900-018-0129-8 · Cited by 135 · see citing works
Global Public Attitudes About Clinical Research and Patient Experiences With Clinical Trials
Anderson, A., Borfitz, D., & Getz, K. A. (2018) · JAMA Network Open · doi:10.1001/jamanetworkopen.2018.2969 · Cited by 134 · see citing works
Patients’ roles and rights in research
Wicks, P. J., Richards, T., Denegri, S., & Godlee, F. (2018) · BMJ · doi:10.1136/bmj.k3193 · Cited by 132 · see citing works
Borno, H. T., Zhang, L., Siegel, A. P., Chang, E. G., & Ryan, C. J. (2018) · The Oncologist · doi:10.1634/theoncologist.2017-0628 · Cited by 125 · see citing works
Skea, Z., Newlands, R. S. N., & Gillies, K. (2019) · BMJ Open · doi:10.1136/bmjopen-2018-021959 · Cited by 95 · see citing works
Brunsdon, D., Biesty, L., Brocklehurst, P., Brueton, V. C., Devane, D., Elliott, J., Galvin, S., Gamble, C. L., Gardner, H., Healy, P., et al. (2019) · Trials · doi:10.1186/s13063-019-3687-7 · Cited by 82 · see citing works
A New Measure of Research Participant Burden
Lingler, J. H., Schmidt, K. L., Gentry, A., Hu, L., & Terhorst, L. A. (2014) · Journal of Empirical Research on Human Research Ethics · doi:10.1177/1556264614545037 · Cited by 78 · see citing works
Respondent Burden in Clinical Research: When Are We Asking Too Much of Subjects?
Ulrich, C. M., Wallen, G. R., Feister, A., & Grady, C. (2005) · IRB Ethics and Human Research · doi:10.2307/3563957 · Cited by 71 · see citing works
Recognizing the Financial Burden of Cancer Patients in Clinical Trials
Nipp, R. D., Powell, E., Chabner, B. A., & Moy, B. (2015) · The Oncologist · doi:10.1634/theoncologist.2015-0068 · Cited by 62 · see citing works
Data collection in cancer clinical trials: Too much of a good thing?
O’Leary, E. M., Seow, H. Y., Julian, J. A., Levine, M. N., & Pond, G. R. (2013) · Clinical Trials · doi:10.1177/1740774513491337 · Cited by 32 · see citing works
Verboom, B., Montgomery, P., & Bennett, S. (2016) · Systematic Reviews · doi:10.1186/s13643-016-0240-6 · Cited by 29 · see citing works
Randomized Trials Stopped Early for Benefit: A Systematic Review
Montori, V. M., Devereaux, P. J., Adhikari, N. K. J., Burns, K. E. A., Eggert, C. H., Briel, M., Lacchetti, C., Leung, T. W., Darling, E., Bryant, D. M., et al. (2005) · JAMA · doi:10.1001/jama.294.17.2203 · Cited by 26 · see citing works
Ahmad, N., Boutron, I., Moher, D., Pitrou, I., Roy, C., & Ravaud, P. (2009) · Arthritis Care & Research · doi:10.1002/art.24279 · Cited by 25 · see citing works
Self-citationEthgen, M., Boutron, I., Steg, P. G., Roy, C., & Ravaud, P. (2009) · BMC Medical Research Methodology · doi:10.1186/1471-2288-9-24 · Cited by 21 · see citing works
Self-citationBurdensome Research Procedures in Trials: Why Less Is More
Kimmelman, J., Resnik, D. B., Peppercorn, J. M., & Ratain, M. J. (2016) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djw315 · Cited by 21 · cited 2× · see citing works
“We also searched Google Scholar and retrieved all studies that cited each of 3 pre-specified “ seed ” publications [3, 17, 18].”
BackgroundMethodYoungson, R., & Blennerhassett, M. (2016) · BMJ · doi:10.1136/bmj.i6262 · Cited by 19 · see citing works
Rate of Refusal to Participate in Clinical Trials
Shimm, D. S., & Spece, R. G. (1992) · IRB Ethics and Human Research · doi:10.2307/3564537 · Cited by 15 · see citing works
Perceived Research Burden Assessment (PeRBA): Instrument Development and Psychometric Evaluation
Lingler, J. H., Schmidt, K., Gentry, A., Hu, L., & Terhorst, L. A. (2014) · Journal of Empirical Research on Human Research Ethics · Cited by 11 · see citing works
Why we revolt: a patient revolution for careful and kind care by Victor Montori
Dinneen, S. F. (2019) · Endocrine · doi:10.1007/s12020-019-01922-z · Cited by 7 · see citing works
Flagged first, then by citations
Research works printed but not linked: 2
- [15]Booth A: Chapter 3: searching for studies. In: Supplementary guidance for inclusion of qualitative research in Cochrane systematic reviews of interventions. Edited by Noyes J BA, Hannes K, Harden A, Harris J, Lewin S, Lockwood C, vol. version 1 (updated August 2011): Cochrane Collaboration Qualitative Methods Group, 2011; 2011.
- [21]Lingler JH Schmidt KL Gentry AL Hu L Terhorst LA A new measure of research participant burden: brief report J Empir Res Hum Res Ethics 2014 9 4 46 49 10.1177/1556264614545037 26125079 PMC4487419 · DOI
Cited by
Sorted by citations
Qualitative Evidence Synthesis: Where Are We at?
Flemming, K., & Noyes, J. (2021) · International Journal of Qualitative Methods · doi:10.1177/1609406921993276 · Cited by 369 · see citing works
“Exploring patient expectations and experiences of remote monitoring for chronic diseases (Walker et al., 2019) Examining the research burden of randomized controlled trial participation (Naidoo et al., 2020).”
BackgroundTremblay, S. M., Castiglione, S. A., Audet, L., Desmarais, M., Horace, M., & Peláez, S. (2021) · International Journal of Qualitative Methods · doi:10.1177/16094069211009679 · Cited by 221 · see citing works
“The exploration of research burden in quantitative research was undertaken in a recent systematic review of qualitative studies in participants of randomized controlled trials (Naidoo et al., 2020).”
MethodEvidence from ClinicalTrials.gov on the growth of Digital Health Technologies in neurology trials
Masanneck, L., Gieseler, P., Gordon, W. J., Meuth, S. G., & Stern, A. D. (2023) · npj Digital Medicine · doi:10.1038/s41746-023-00767-1 · Cited by 94 · see citing works
Under-Enrollment of Women in Stroke Clinical Trials
Carcel, C., & Reeves, M. J. (2021) · Stroke · doi:10.1161/strokeaha.120.033227 · Cited by 83 · see citing works
Parental Views of Facilitators and Barriers to Research Participation: Systematic Review
Nathe, J. M., Oskoui, T., & Weiss, E. M. (2022) · PEDIATRICS · doi:10.1542/peds.2022-058067 · Cited by 65 · see citing works
Garrity, K., Guerra, K. K., Hart, H., Al-Muhanna, K., Kunkler, E. C., Braun, A. C., Poppe, K. I., Johnson, K., Lazor, E., Liu, Y., et al. (2024) · Advances in Nutrition · doi:10.1016/j.advnut.2023.100156 · Cited by 65 · see citing works
Ismailov, M., Chiu, T. K. F., Dearden, J., Yamamoto, Y., & Djalilova, N. (2021) · Sustainability · doi:10.3390/su132212642 · Cited by 70 · see citing works
COllaborative open platform E-cohorts for research acceleration in trials and epidemiology
Tran, V.-T., & Ravaud, P. (2020) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2020.04.021 · Cited by 51 · see citing works
Self-citationHoenemeyer, T. W., Cole, W. W., Oster, R. A., Pekmezi, D., Pye, A., & Demark‐Wahnefried, W. (2022) · Cancers · doi:10.3390/cancers14041075 · Cited by 41 · see citing works
Hall, C. L., Sanderson, C., Brown, B. J., Andrén, P., Bennett, S. D., Chamberlain, L. R., Davies, E. B., Khan, K., Kouzoupi, N., Mataix‐Cols, D., et al. (2020) · Trials · doi:10.1186/s13063-020-04902-1 · Cited by 37 · see citing works
Han, A., Yuen, H. K., & Jenkins, J. (2023) · Journal of Health Psychology · doi:10.1177/13591053221141131 · Cited by 30 · see citing works
“…pretestposttest 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 (Naidoo et al., 2020).”
BackgroundAguayo, G., Goetzinger, C., Scibilia, R., Fischer, A., Seuring, T., Tran, V.-T., Ravaud, P., Bereczky, T., Huiart, L., & Fagherazzi, G. (2021) · Journal of Medical Internet Research · doi:10.2196/25743 · Cited by 32 · see citing works
“Nevertheless, when done properly, patients can associate their participation with feelings such as usefulness, empowerment, and consideration [150].”
Self-citationShankar, M., Hazfiarini, A., Zahroh, R. I., Vogel, J. P., McDougall, A. R. A., Condron, P., Goudar, S. S., Pujar, Y. V., Somannavar, M. S., Charantimath, U., et al. (2024) · PLoS Medicine · doi:10.1371/journal.pmed.1004405 · Cited by 32 · see citing works
van der Hout, A., van Uden-Kraan, C. F., Holtmaat, K., Jansen, F., Lissenberg-Witte, B. I., Nieuwenhuijzen, G. A. P., Hardillo, J. A., Baatenburg de Jong, R. J., Tiren-Verbeet, N. L., Sommeijer, D. W., et al. (2021) · Internet Interventions · doi:10.1016/j.invent.2021.100429 · Cited by 29 · see citing works
Ferrar, J., Griffith, G. J., Skirrow, C., Cashdollar, N. M., Taptiklis, N., Dobson, J., Cree, F., Cormack, F. K., Barnett, J. H., & Munafo, M. R. (2021) · Journal of Medical Internet Research · doi:10.2196/26004 · Cited by 23 · see citing works
“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].”
BackgroundTrial Participation in Neurodegenerative Diseases: Barriers and Facilitators
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 · see citing works
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 · see citing works
“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).”
Stone, B., Sambo, J. A. M., Sawadogo‐Lewis, T., & Roberton, T. (2020) · BMC Health Services Research · doi:10.1186/s12913-020-05807-0 · Cited by 20 · see citing works
Pilot Trial Characteristics, Postpilot Design Modifications, and Feasibility of Full-Scale Trials
Ying, X., & Ehrhardt, S. (2023) · JAMA Network Open · doi:10.1001/jamanetworkopen.2023.33642 · Cited by 20 · see citing works
Madruga‐Garrido, M., Vazquez-Costa, J. F., Medina-Cantillo, J., Brañas, M., Cattinari, M. G., de Lemus, M., Díaz-Abós, P., Sánchez-Menéndez, V., Terrancle, Á., Rebollo, P., et al. (2021) · Neurology and Therapy · doi:10.1007/s40120-020-00229-w · Cited by 19 · see citing works
“effort required by the respondent, the amount of stress, and the length and frequency of scales and questionnaires [23].”
BackgroundImplementation of digital health technology in clinical trials: the 6R framework
Duran, C., Bonam, M., Björk, E., Hughes, R., Ghiorghiu, S., Massacesi, C., Campbell, A., Hutchison, E. R., Pangalos, M. N., & Galbraith, S. M. (2023) · Nature Medicine · doi:10.1038/s41591-023-02489-z · Cited by 19 · see citing works
Chi, P. C., Owino, E. A., Jao, I., Olewe, F. O., Ogutu, B. R., Bejon, P., Kapulu, M. C., Kamuya, D., Marsh, V., CHMI-SIKA Study Team, et al. (2021) · Trials · doi:10.1186/s13063-021-05455-7 · Cited by 19 · see citing works
“The diverse nature of burdens and benefits has also been shown for different forms of research; a systematic review of qualitative studies around randomised clinical trials (largely in high resource settings) highlighted the existence of physical, psychological and cost-related burdens, including psychological burdens…”
BackgroundKnowlson, C. N., Dean, A., Doherty, L., Fairhurst, C. M., Brealey, S., & Torgerson, D. J. (2021) · Contemporary Clinical Trials · doi:10.1016/j.cct.2021.106665 · Cited by 18 · see citing works
Meskell, P., Biesty, L., Dowling, M., Roche, K. F., Meehan, E., Glenton, C., Devane, D., Shepperd, S., Booth, A., Cox, R. J., et al. (2023) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.mr000065.pub2 · Cited by 17 · see citing works
Nguyen, V. T., Ravaud, P., Tran, V. T., Young, B., & Boutron, I. (2022) · Journal of Medical Internet Research · doi:10.2196/29691 · Cited by 17 · see citing works
“Evidence shows that participating in RCTs can be burdensome for patients, particularly due to the ways informed consent is managed, follow-up visits organized, and trial results communicated [5,6].”
BackgroundSelf-citationClinical Trial Participation: A Pilot Study of Patient-Identified Barriers
McKinney, M., Bell, R., Samborski, C., Attwood, K., Dean, G., Eakle, K., & Edge, S. (2021) · Clinical journal of oncology nursing · doi:10.1188/21.cjon.647-654 · Cited by 17 · see citing works
“This has been examined extensively in the literature (Manne et al., 2015; Mills et al., 2006; Naidoo et al., 2020; Nielsen & Berthelsen, 2019; Sedrak et al., 2021).”
Designing clinically useful psychopharmacological trials: challenges and ways forward
Chevance, A., Ravaud, P., Cornelius, V. R., Mayo‐Wilson, E., & Furukawa, T. A. (2022) · The Lancet Psychiatry · doi:10.1016/s2215-0366(22)00041-4 · Cited by 17 · see citing works
Self-citationRønsbo, T. N., Laigaard, J., Pedersen, C., Mathiesen, O., & Karlsen, A. P. H. (2021) · Trials · doi:10.1186/s13063-021-05233-5 · Cited by 16 · see citing works
“The authors concluded that these burdens could be anticipated by conducting minimally disruptive clinical research, which in terms could improve trial recruitment and retention [23].”
BackgroundBaker, F. A., Blauth, L., Bloska, J., Bukowska, A. A., Flynn, L. M., Hsu, M., Janus, E., Johansson, K., Odell‐Miller, H., Miller, H., et al. (2023) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2023.101079 · Cited by 17 · see citing works
“Increased participant burden is a factor influencing the decision whether to participate in research [4].”
BackgroundNew horizons in evidence-based care for older people: individual participant data meta-analysis
Clegg, A. P., Bandeen‐Roche, K., Farrin, A. J., Förster, A., Gill, T. M., Gladman, J. R. F., Kerse, N. M., Lindley, R. I., McManus, R. J., Melis, R. J. F., et al. (2022) · Age and Ageing · doi:10.1093/ageing/afac090 · Cited by 16 · see citing works
“Given the relative paucity of empirical evidence [33], future work should evaluate potential data collection burden while attempting to develop CDEs and COMs.”
Time Burdens for Participants With Advanced Cancer in Phase I Trials: A Cross-Sectional Study
Iskander, R., Robart, A. M., Moyer, H., Nipp, R. D., Gupta, A., & Kimmelman, J. (2024) · JCO Oncology Practice · doi:10.1200/op.24.00334 · Cited by 14 · see citing works
French Public Familiarity and Attitudes toward Clinical Research during the COVID-19 Pandemic
Schultz, É., Ward, J. K., Atlani-Duault, L., Holmes, S. M., & Mancini, J. (2021) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph18052611 · Cited by 14 · see citing works
Understanding the Termination of Urologic Cancer Clinical Trials: Insights and Challenges
Alhajahjeh, A. A., Hmeidan, M., Elatrsh, M., Al-Abbadi, F., Kakish, D. R. K., Sukerji, R., Salah, M., Awamlh, B. A. H. A., Lee, D. I., & Shahait, M. (2024) · JCO Global Oncology · doi:10.1200/go.23.00349 · Cited by 11 · see citing works
Knapp, P., Bower, P., Lidster, A., O'Hare, H., Sol, L. F., Golder, S., Keyworth, C., Parker, A., & Sheridan, R. (2025) · Trials · doi:10.1186/s13063-025-08850-6 · Cited by 13 · see citing works
“%) included only qualitative studies [32, 41, 50, 52, 56, 69, 72–74, 77, 89], three (4.3”
InfluentialMacDonald, S., Trubey, R., Noyes, J., Vinnicombe, S., Morgan, H. E., Willis, S., Boffey, M., Meléndez‐Torres, G. J., Robling, M. R., Wooders, C., et al. (2023) · Children and Youth Services Review · doi:10.1016/j.childyouth.2023.107266 · Cited by 12 · see citing works
“Supporting carers, other participants and other stakeholders to manage these burdens, including different burdens experienced across the intervention process, is a future priority given its implications for intervention recruitment and retention (Lingler et al., 2014; Naidoo et al., 2020).”
BackgroundRegret and Therapeutic Decisions in Multiple Sclerosis Care: Literature Review and Research Protocol
Saposnik, G., Bueno-Gil, G., Sempere, Á. P., Antigüedad, A. R., del Río, B., Baz, M., Terzaghi, M., Ballesteros, J., & Mauriño, J. (2021) · Frontiers in Neurology · doi:10.3389/fneur.2021.675520 · Cited by 13 · see citing works
“Finally, we acknowledge that increased response burden may be associated with lower response rates (57, 58).”
BackgroundBurden of cancer trial participation: A qualitative sub-study of the INTERIM feasibility RCT
Nwolise, C. H., Corrie, P. G., Fitzpatrick, R. M., Gupta, A., Jenkinson, C., Middleton, M. R., & Matin, R. (2021) · Chronic Illness · doi:10.1177/17423953211060253 · Cited by 12 · see citing works
“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.”
BackgroundResultInfluentialElfeky, A., Treweek, S. P., Hannes, K., Bruhn, H., Fraser, C. M., & Gillies, K. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-055521 · Cited by 12 · see citing works
“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.”
Freund, O., Meoded, O., Arnaout, T., Regev, I. F., Kupershmidt, A., Enghelberg, S., Cohn‐Schwartz, D., Levy, L., & Bar‐Shai, A. (2025) · International Journal of COPD · doi:10.2147/copd.s525781 · Cited by 11 · see citing works
“18 Considering the above, although an RCT provides the highest level of evidence, its generalizability to real-life may be limited, hence requiring further real-world evidence.”
van Lieshout, E. C., Jacobs, L. D., Pelsma, M., Dijkhuizen, R. M., & Visser‐Meily, J. M. A. (2020) · BMC Neurology · doi:10.1186/s12883-020-01936-5 · Cited by 11 · see citing works
Hanlon, P., Butterly, E. W., Shah, A. S. V., Hannigan, L. J., Wild, S. H., Guthrie, B., Mair, F. S., Dias, S., Welton, N. J., & McAllister, D. (2022) · BMC Medicine · doi:10.1186/s12916-022-02594-9 · Cited by 10 · see citing works
“Although not always an explicit exclusion criterion, investigators also routinely exclude people who have concerns over an individual’s ability to manage the burdens of trial participation [2], in order to minimise loss to follow-up [3].”
BackgroundFurness, K., Huggins, C. E., Truby, H., Croagh, D. G., & Haines, T. P. (2020) · JMIR Formative Research · doi:10.2196/23979 · Cited by 11 · see citing works
“These psychological and emotional effects on participants at the conclusion of trials have been reported in a number of other qualitative articles examining postintervention transition to usual care, with participants reporting a sense of loss, disappointment, anxiety, and isolation [32,33].”
BackgroundAssessment of inverse publication bias in safety outcomes: an empirical analysis
Xing, X., Zhu, J., Shi, L., Xu, C., & Lin, L. (2024) · BMC Medicine · doi:10.1186/s12916-024-03707-2 · Cited by 9 · see citing works
Jones, K., Naisby, J., Baker, K., & Tew, G. A. (2023) · Crohn s & Colitis 360 · doi:10.1093/crocol/otad019 · Cited by 9 · see citing works
“38,39 Personal benefit was also influential, with some individuals hoping it would further their knowledge of the condition and exercise and would lead to alternative treatment options.”
BackgroundRacial and Ethnic Diversity in Studies Funded Under the Best Pharmaceuticals for Children Act
Abdel‐Rahman, S. M., Paul, I. M., Hornik, C. D., Sullivan, J. E., Wade, K. C., Delmore, P., Sharma, G., Benjamin, D. K., & Zimmerman, K. O. (2021) · PEDIATRICS · doi:10.1542/peds.2020-042903 · Cited by 9 · see citing works
Stinissen, L., Bouma, S., Böhm, J., van Tienen, J., Fischer, H., Hughes, Z., Lennox, A., Ward, E. D., Wood, M., Foley, A. R., et al. (2023) · Neuromuscular Disorders · doi:10.1016/j.nmd.2023.12.014 · Cited by 8 · see citing works
Disseminating clinical study results to trial participants in Ethiopia: insights and lessons learned
Degaga, T. S., Weston, S., Tego, T. T., Tadesse, D., Assefa, A., Wayessa, A., Price, R. N., Hailu, A., & Thriemer, K. (2020) · Malaria Journal · doi:10.1186/s12936-020-03279-5 · Cited by 8 · see citing works
Lawson, L. M., Foster, L. H., Hamner, K., & Wright, L. (2022) · Occupational Therapy International · doi:10.1155/2022/3540271 · Cited by 11 · see citing works
“autistic children thrive on routine, parent stress may have been impacted by change in routine to introduce the sensory garments [10, 13] or the potential burden of research participation [42].”
BackgroundPaulissen, J. M. J., Zegers, C. M. L., Nijsten, I. R., Reiters, P. H. C. M., Houben, R. M. A., Eekers, D. B. P., & Roelofs, E. (2022) · Technical Innovations & Patient Support in Radiation Oncology · doi:10.1016/j.tipsro.2022.10.005 · Cited by 9 · see citing works
“This can cause a significant burden with a typical dropout rate of 25 % for clinical cancer trials (CCTs) [7 – 9].”
BackgroundImplementing Decentralized Clinical Trials in Australia through Teletrials: Where to From Here?
Symons, T. J., Woollett, A., Zalcberg, J. R., & Eckstein, L. (2024) · Therapeutic Innovation & Regulatory Science · doi:10.1007/s43441-024-00658-x · Cited by 7 · see citing works
“Trial-related travel is perceived by many participants as inconvenient and burdensome [1, 2].”
Jörger, P., Nigg, C., Mader, L., Strebel, S., Kompis, M., Tomášiková, Z., Schindera, C., Michel, G., von der Weid, N., Ansari, M., et al. (2025) · JMIR Research Protocols · doi:10.2196/63627 · Cited by 7 · see citing works
Czwikla, J., Herzberg, A., Kapp, S., Kloep, S., Rothgang, H., Nitschke, I., Haffner, C., & Hoffmann, F. (2022) · Trials · doi:10.1186/s13063-022-06470-y · Cited by 6 · see citing works
Informed Consent Documents from Psychedelic Clinical Trials: A Descriptive Ethical Analysis
Cheung, K., Propes, C., Graziosi, M., Patch, K., & Yaden, D. B. (2025) · AJOB Empirical Bioethics · doi:10.1080/23294515.2025.2526339 · Cited by 6 · see citing works
“These challenges are part of a broader conversation about the burdens that trial participation places on individuals (e.g., financial, psychological, and physical) and measures that can be used to alleviate them 3 (Naidoo et al. 2020).”
Watson, J. M., Coleman, E., Jackson, C., Bell, K. J., Maynard, C., Hickson, L. M. H., Förster, A., Fairhurst, C. M., Hewitt, C. E., Gardner, R., et al. (2021) · BMJ Open · doi:10.1136/bmjopen-2020-043364 · Cited by 6 · see citing works
Facilitated transition in HIV drug trial closure: A conceptual model for HIV post-trial care
Nalubega, S., Cox, K., Mugerwa, H., & Evans, C. (2021) · PLoS ONE · doi:10.1371/journal.pone.0250698 · Cited by 6 · see citing works
Insights from UKCTOCS for design, conduct and analyses of large randomised controlled trials
Menon, U., Gentry‐Maharaj, A., Burnell, M., Apostolidou, S., Ryan, A., Kalsi, J., Singh, N., Fallowfield, L. J., McGuire, A. J., Campbell, S. C., et al. (2023) · Health Technology Assessment · doi:10.3310/cldc7214 · Cited by 5 · see citing works
The Human Cost: Patient Contribution to Clinical Trials in Neurology
Reoma, L. B., & Karp, B. I. (2022) · Neurotherapeutics · doi:10.1007/s13311-022-01292-x · Cited by 5 · see citing works
“Numbers alone are not indicative of patient burden for those joining clinical trials, including the “psychological, physical and financial burdens” due to research participation [14].”
BackgroundDibley, L. B., Hart, A. L., Duncan*, J., Knowles, C. H., Kerry, S., Lanz, D., Berdunov, V., Madurasinghe, V., Wade, T., Terry, H., et al. (2023) · Journal of Wound Ostomy and Continence Nursing · doi:10.1097/won.0000000000000979 · Cited by 5 · see citing works
Kushnir, I., Clemons, M. J., Fergusson, D. A., Bossé, D., & Reaume, M. N. (2022) · Journal of Evaluation in Clinical Practice · doi:10.1111/jep.13669 · Cited by 4 · see citing works
“Unfortunately, in addition to missing any potential benefit of the investigational treatment arm, patients randomized to the placebo arm often suffer inconveniences of being on placebo including travel expenses, multiple appointments, work absence and loss of income and venipuncture.(5,6) An open‐label nonintervention…”
BackgroundPluess-Hall, H., Smith, P. C., & Menzies, J. C. (2024) · Clinical Trials · doi:10.1177/17407745241296864 · Cited by 4 · see citing works
“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 · see citing works
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 · see citing works
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 · see citing works
“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 · see citing works
Massey, H. C., Denton, H., Burlingham, A., Violato, M., Bibby-Jones, A.-M., Cunningham, R., Ciccognani, S., Robertson, S., Jhans, A., Pollard, J., et al. (2025) · Mental health and physical activity · doi:10.1016/j.mhpa.2025.100723 · Cited by 3 · see citing works
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 · see citing works
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 · see citing works
Lucas, P., Boyd, S. C., Milloy, M., & Walsh, Z. (2021) · Journal of Cannabis Research · doi:10.1186/s42238-021-00089-7 · Cited by 3 · see citing works
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 2 · see citing works
“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 · see citing works
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 · see citing works
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 · see citing works
“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 · see citing works
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 · see citing works
“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 · see citing works
“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 · see citing works
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 · see citing works
“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 · see citing works
Anticipatory Burden in Adult-Child Caregivers: A Concept Analysis
She, H., & Man, Y. (2022) · Healthcare · doi:10.3390/healthcare10020356 · Cited by 2 · see citing works
Martínez, C., Feliu, A., Torres, N., Nieva, G., Pinet, C., Raich, A., Mondón, S., Barrio, P., Andreu, M., Hernández‐Ribas, R., et al. (2022) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2022.109390 · Cited by 2 · see citing works
Blomberg, H., Kroll, C., & Tarkiainen, L. (2024) · Journal of European Social Policy · doi:10.1177/09589287241284780 · Cited by 2 · see citing works
“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 · see citing works
Neurorehabilitation for upper limb recovery after stroke
van Lieshout, E. C. (2021) · doi:10.33540/420 · Cited by 2 · see citing works
Kluge, L., Holter, H., Bergh, C., & Thurin‐Kjellberg, A. (2023) · Reproductive Female and Child Health · doi:10.1002/rfc2.48 · Cited by 2 · see citing works
Abdel‐Rahman, S. M., Sund, Z. M., Alderman, C., Abella, K., & Kennel, P. (2025) · Therapeutic Innovation & Regulatory Science · doi:10.1007/s43441-025-00760-8 · Cited by 1 · see citing works
“…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 · see citing works
“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].”
Zhang, Y., Rong, J., Wang, X., Schramm, E., Pathiravasan, C. H., Borrelli, B., Faro, J. M., Benjamin, E. J., Trinquart, L., Liu, C., et al. (2025) · Journal of Medical Internet Research · doi:10.2196/73972 · Cited by 2 · see citing works
“A systematic review of RCT participation burden found that more frequent questionnaires increased patient workload, where they compared daily versus weekly assessments [51].”
Nowojewski, A., Wheal, A., Dott, W., Ruscica, D., Ghiorghiu, S., & Valastro, B. (2025) · BMJ Open · doi:10.1136/bmjopen-2024-094596 · Cited by 1 · see citing works
Furman, C. R., & Volz, S. C. (2026) · Applied Psychology Health and Well-Being · doi:10.1111/aphw.70110 · Cited by 1 · see citing works
“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
Law, E., & Chatfield, K. (2026) · Trials · doi:10.1186/s13063-026-09540-7 · Cited by 1 · see citing works
“[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 · see citing works
“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 · see citing works
“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 · see citing works
The DCM Project Portal: A direct-to-participant platform of The DCM Research Project
Jordan, E. S., Grover, P. L., Lin, J., Starkey, C. A., Finley, E., Ni, H., & Hershberger, R. E. (2023) · American Heart Journal Plus Cardiology Research and Practice · doi:10.1016/j.ahjo.2023.100356 · Cited by 1 · see citing works
“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 · see citing works
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 · see citing works
Sherratt, F. C., McCarthy, C., Jiménez-Tomàs, A., Perry, J., Kuruvilla, R., Ho, M. W., Fedele, S., Daunt, M., Moorhouse, S., Shaw, R., et al. (2025) · BMJ Open · doi:10.1136/bmjopen-2025-101326 · Cited by 1 · see citing works
Self-citationCaring for Patients in an Evidence-Limited World
Ramaswamy, R., & Leipzig, R. M. (2021) · Springer eBooks · doi:10.1007/978-3-030-01782-8_3-1 · Cited by 1 · see citing works
Gu, J., Dunlop, A. D., Donovan, L., & Chaput, K. H. (2025) · medRxiv · doi:10.1101/2025.11.17.25340428 · Cited by 1 · see citing works
“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
- 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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