Recording and reporting of recruitment strategies in trial protocols, registries, and publications was nonexistent
Abstract
Objectives To investigate how trialists record and report their recruitment strategies and the recruiter details in trial protocols, registries, and publications.Study design and setting A retrospective study of ovarian cancer (OC) trials between 2010 and 2021. We reviewed 154 trial publications, 30 protocols, 105 registry entries, and 26 trial websites associated with 88 phase III OC trials.Results None of the 88 trials reviewed published a recruitment strategy or made reference to an available recruitment strategy for the trial. Only 31% (n = 28) made reference to the recruiter but this was reported only in the protocol so we have no evidence these named recruiters performed the task. None of the trials reviewed which closed early or extended recruitment timelines due to slow accrual, reported measures taken to improve recruitment rates before stoppages or changes took place. There were disparities in the reported target recruitment numbers between the protocol, the publication, and the registry.Conclusion Recruitment strategies exist, and we are sure most trial centers use recruitment strategies, but they need to be recorded and reported, as part of the supplementary material if not the main publication, so we can evaluate their effectiveness.
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Although most trials will use strategies to promote enrolment of participants, this information is often incompletely reported in trial protocols.
“Although most trials will use strategies to promote enrolment of participants, this information is often incompletely reported in trial protocols.9 10 317”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [317]
Cites
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Chan, A.-W., Tetzlaff, J. M., Gotzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hrobjartsson, A., Schulz, K. F., Parulekar, W. R., et al. (2013) · BMJ · doi:10.1136/bmj.e7586 · Cited by 6,251 · see citing works
Neoadjuvant Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian Cancer
Vergote, I. B., Trope, C. G., Amant, F. C., Kristensen, G. B., Ehlen, T., Johnson, N. P., Verheijen, R. H. M., van der Burg, M. E. L., Lacave, Á. J., Panici, P. B., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa0908806 · Cited by 2,538 · see citing works
Moher, D., Hopewell, S., Schulz, K. F., Montori, V., Gøtzsche, P. C., Devereaux, P. J., Elbourne, D., Egger, M., & Altman, D. G. (2012) · International Journal of Surgery · doi:10.1016/j.ijsu.2011.10.001 · Cited by 2,345 · see citing works
Pujade-Lauraine, É., Ledermann, J. A., Selle, F., Gebski, V., Penson, R. T., Oza, A. M., Korach, J., Huzarski, T., Poveda, A. M., Pignata, S., et al. (2017) · The Lancet Oncology · doi:10.1016/s1470-2045(17)30469-2 · Cited by 1,856 · see citing works
Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer
van Driel, W. J., Koole, S. N., Sikorska, K., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1708618 · Cited by 1,445 · see citing works
The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies
Unger, J. M., Cook, E., Tai, E., & Bleyer, A. (2016) · American Society of Clinical Oncology Educational Book · doi:10.1200/edbk_156686 · Cited by 665 · see citing works
de Boer, S. M., Powell, M. E. B., Mileshkin, L., Katsaros, D., Bessette, P., Haie-Méder, C., Ottevanger, P. B., Ledermann, J. A., Khaw, P., Colombo, A., et al. (2018) · The Lancet Oncology · doi:10.1016/s1470-2045(18)30079-2 · Cited by 646 · 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 · see citing works
Sully, B. G. O., Julious, S. A., & Nicholl, J. (2013) · Trials · doi:10.1186/1745-6215-14-166 · Cited by 410 · see citing works
Fagotti, A., Ferrandina, G., Vizzielli, G., et al. (2016) · European Journal of Cancer · doi:10.1016/j.ejca.2016.01.017 · Cited by 408 · 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
Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy
Jenkins, V. A., & Fallowfield, L. J. (2000) · British Journal of Cancer · doi:10.1054/bjoc.2000.1142 · Cited by 317 · see citing works
Heller, C. A., Balls‐Berry, J. E., Nery, J. D., Erwin, P. J., Littleton, D. M., Kim, M., & Kuo, W. P. (2014) · Contemporary Clinical Trials · doi:10.1016/j.cct.2014.08.004 · Cited by 289 · see citing works
Donovan, J., Rooshenas, L., Jepson, M., Elliott, D., Wade, J., AVERY, K. N. L., Mills, N., Wilson, C., Paramasivan, S., & Blazeby, J. M. (2016) · Trials · doi:10.1186/s13063-016-1391-4 · Cited by 270 · see citing works
Influence of Clinical Communication on Patients' Decision Making on Participation in Clinical Trials
Albrecht, T. L., Eggly, S. S., Gleason, M. E. J., Harper, F. W. K., Foster, T. S., Peterson, A. M., Orom, H., Penner, L. A., & Ruckdeschel, J. C. (2008) · Journal of Clinical Oncology · doi:10.1200/jco.2007.14.8114 · Cited by 249 · see citing works
Walker, J. L., Brady, M. F., Wenzel, L. B., Fleming, G. F., Huang, H. Q., DiSilvestro, P., Fujiwara, K., Alberts, D. S., Zheng, W., Tewari, K. S., et al. (2019) · Journal of Clinical Oncology · doi:10.1200/jco.18.01568 · Cited by 230 · see citing works
Pignata, S., Scambia, G., Ferrandina, G., Savarese, A., Sorio, R., Breda, E., Gebbia, V., Musso, P., Frigerio, L., Del Medico, P., et al. (2011) · Journal of Clinical Oncology · doi:10.1200/jco.2010.33.8566 · Cited by 229 · see citing works
Sheridan, R., Martin-Kerry, J., Hudson, J., Parker, A., Bower, P., & Knapp, P. (2020) · Trials · doi:10.1186/s13063-020-4197-3 · Cited by 223 · see citing works
Aaronson, N. K., Visser-Pol, E., Leenhouts, G., Muller, M. J., van der Schot, A. C., van Dam, F. S. A. M., Keus, R. B., Koning, C. C. E., Huinink, W. W. T. B., van Dongen, J. A., et al. (1996) · Journal of Clinical Oncology · doi:10.1200/jco.1996.14.3.984 · Cited by 184 · see citing works
Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis
Brøgger‐Mikkelsen, M., Ali, Z., Zibert, J. R., Andersen, A. D., & Thomsen, S. F. (2020) · Journal of Medical Internet Research · doi:10.2196/22179 · Cited by 167 · see citing works
Monk, B. J., Grisham, R. N., Banerjee, S. N., Kalbacher, E., Mirza, M. R., Romero, I., Vuylsteke, P., Coleman, R. L., Hilpert, F., Oza, A. M., et al. (2020) · Journal of Clinical Oncology · doi:10.1200/jco.20.01164 · Cited by 158 · see citing works
Strategic Physician Communication and Oncology Clinical Trials
Albrecht, T. L., Blanchard, C. G., Ruckdeschel, J. C., Coovert, M. D., & Strongbow, R. (1999) · Journal of Clinical Oncology · doi:10.1200/jco.1999.17.10.3324 · Cited by 157 · 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
Recruitment and retention of participants in clinical studies: Critical issues and challenges
Desai, M. K. (2020) · Perspectives in Clinical Research · doi:10.4103/picr.picr_6_20 · Cited by 115 · see citing works
Cox, K. (2002) · Patient Education and Counseling · doi:10.1016/s0738-3991(01)00147-1 · Cited by 103 · see citing works
Rooshenas, L., Scott, L. J., Blazeby, J. M., Rogers, C. A., Tilling, K. M., Husbands, S., Conefrey, C., Mills, N., Stein, R. C., Metcalfe, C., et al. (2018) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2018.10.004 · Cited by 91 · see citing works
Hutchison, C., Cowan, C., McMahon, T. J., & Paul, J. (2007) · British Journal of Cancer · doi:10.1038/sj.bjc.6603943 · Cited by 85 · see citing works
Juraskova, I., Butow, P. N., Bonner, C., Bell, M. L., Smith, A. B., Seccombe, M., Boyle, F. M., Reaby, L., Cuzick, J. M., & Forbes, J. (2014) · British Journal of Cancer · doi:10.1038/bjc.2014.144 · Cited by 84 · see citing works
Moore, K. N., Vergote, I. B., Oaknin, A., Colombo, N., Banerjee, S. N., Oza, A. M., Pautier, P., Malek, K. S., & Birrer, M. J. (2018) · Future Oncology · doi:10.2217/fon-2017-0646 · Cited by 76 · see citing works
Increasing participation of cancer patients in randomised controlled trials: a systematic review
McDaid, C., Hodges, Z., Fayter, D., Stirk, L., & Eastwood, A. J. (2006) · Trials · doi:10.1186/1745-6215-7-16 · Cited by 71 · see citing works
Oza, A. M., Selle, F., Давиденко, І., Korach, J., Mendiola, C., Pautier, P., Chmielowska, E., Bamias, A., DeCensi, A., Zvirbule, Z., et al. (2016) · International Journal of Gynecological Cancer · doi:10.1097/igc.0000000000000836 · Cited by 71 · see citing works
Mahner, S., Heitz, F., Burges, A., et al. (2017) · Journal of Clinical Oncology · doi:10.1200/jco.2017.35.15_suppl.tps5602 · Cited by 69 · see citing works
An intervention to improve cancer patients' understanding of early-phase clinical trials.
KASS, N. E., Sugarman, J., Medley, A. M., et al. (2009) · PubMed · Cited by 66 · see citing works
Briel, M., Speich, B., von Elm, E. B., & Gloy, V. (2019) · Trials · doi:10.1186/s13063-019-3957-4 · Cited by 64 · see citing works
Decision Aids Can Support Cancer Clinical Trials Decisions: Results of a Randomized Trial
Politi, M. C., Kuzemchak, M. D., Kaphingst, K. A., Perkins, H., Liu, J., & Byrne, M. M. (2016) · The Oncologist · doi:10.1634/theoncologist.2016-0068 · Cited by 56 · see citing works
AASAP: A program to increase recruitment and retention in clinical trials
Fisher, L., Hessler, D., Naranjo, D. M., & Polonsky, W. H. (2011) · Patient Education and Counseling · doi:10.1016/j.pec.2011.07.002 · Cited by 55 · see citing works
“Entering a clinical trial: Is it right for you?”
Hoffner, B., Bauer‐Wu, S., Hitchcock‐Bryan, S., Powell, M. E., Wolanski, A., & Joffe, S. (2011) · Cancer · doi:10.1002/cncr.26438 · Cited by 48 · see citing works
Moore, K. N., & Pignata, S. (2019) · International Journal of Gynecological Cancer · doi:10.1136/ijgc-2018-000071 · Cited by 48 · see citing works
The Challenges of Informed Consent in High-Stakes, Randomized Oncology Trials: A Systematic Review
Nathe, J. M., & Krakow, E. F. (2019) · MDM Policy & Practice · doi:10.1177/2381468319840322 · Cited by 42 · see citing works
Gillies, K., Chalmers, I., Glasziou, P., Elbourne, D. R., Elliott, J., & Treweek, S. P. (2019) · Trials · doi:10.1186/s13063-019-3704-x · Cited by 42 · see citing works
Fotopoulou, C., Vergote, I. B., Mainwaring, P. N., et al. (2013) · Annals of Oncology · doi:10.1093/annonc/mdt515 · Cited by 40 · see citing works
Berrios, C., James, C. A., Raraigh, K. S., et al. (2017) · Journal of Genetic Counseling · doi:10.1007/s10897-017-0143-2 · Cited by 33 · see citing works
The Role of Nonverbal Communication Behaviors in Clinical Trial and Research Study Recruitment
Morgan, S. E., Occa, A., Mouton, A., & Potter, J. E. (2016) · Health Communication · doi:10.1080/10410236.2016.1140266 · Cited by 29 · see citing works
Parker, A., Knapp, P., Treweek, S. P., Madhurasinghe, V., Littleford, R. C., Gallant, S., Sullivan, F., Schembri, S., Rick, J., Graffy, J., et al. (2018) · Trials · doi:10.1186/s13063-018-2896-9 · Cited by 29 · see citing works
Sherratt, F. C., Brown, S. L., Haylock, B. J., Francis, P., Hickey, H., Gamble, C. L., Jenkinson, M. D., & Young, B. (2020) · The Oncologist · doi:10.1634/theoncologist.2019-0571 · Cited by 27 · see citing works
Ditai, J., Kanyago, J., Nambozo, M., et al. (2018) · Trials · doi:10.1186/s13063-018-3030-8 · Cited by 25 · see citing works
Wuensch, A., Goelz, T., Ihorst, G., Terris, D. D., Bertz, H., Bengel, J., Wirsching, M., & Fritzsche, K. (2017) · BMC Cancer · doi:10.1186/s12885-017-3238-0 · Cited by 24 · see citing works
Adams, S. A., Heiney, S. P., Brandt, H. M., Wirth, M. D., Khan, S., Johnson, H., Davis, L., Wineglass, C. M., Warren-Jones, T. Y., Felder, T. M., et al. (2014) · Journal of Community Health · doi:10.1007/s10900-014-9924-9 · Cited by 23 · see citing works
The Role of Physician Characteristics in Clinical Trial Acceptance: Testing Pathways of Influence
Curbow, B. A., Fogarty, L., McDonnell, K. A., Chill, J., & Scott, L. B. (2006) · Journal of Health Communication · doi:10.1080/10810730500526703 · Cited by 23 · see citing works
The many faces of recruitment in a randomized controlled trial
Pinto, B. M., & DUNSIGER, S. I. (2021) · Contemporary Clinical Trials · doi:10.1016/j.cct.2021.106285 · Cited by 23 · see citing works
Organisational factors influencing early clinical trials enrollment: Gustave Roussy experience
Besle, S., Schultz, É., Hollebecque, A., Varga, A., Baldini, C., Martin, P., Postel-Vinay, S. C., Bahleda, R., Gazzah, A., Michot, J., et al. (2018) · European Journal of Cancer · doi:10.1016/j.ejca.2018.04.019 · Cited by 17 · see citing works
Delaney, H., Devane, D., Hunter, A., Hennessy, M., Parker, A., Murphy, L., Cronin, P., & Smith, V. A. (2019) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2019.05.013 · Cited by 17 · see citing works
Lack of timely accrual information in oncology clinical trials: a cross-sectional analysis
Mitchell, A. P., Hirsch, B. R., & Abernethy, A. P. (2014) · Trials · doi:10.1186/1745-6215-15-92 · Cited by 15 · see citing works
Trung, L. Q., Morra, M. E., Truong, N. D., Turk, T., Elshafie, A. H., Foly, A. S., Tam, D. N. H., Iraqi, A., Van, T. T. H., Elgebaly, A. S., et al. (2017) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.08.007 · Cited by 14 · see citing works
Conefrey, C., Donovan, J., Stein, R. C., Paramasivan, S., Marshall, A., Bartlett, J. M. S., Cameron, D., Campbell, A. M., Dunn, J., Earl, H. M., et al. (2020) · Clinical Oncology · doi:10.1016/j.clon.2020.01.029 · Cited by 12 · see citing works
Krutsinger, D. C., McMahon, J., Stephens‐Shields, A. J., Bayes, B. A., Brooks, S., Hitsman, B. L., Lubitz, S. F., Reyes, C., Schnoll, R. A., Greysen, S. R., et al. (2018) · Contemporary Clinical Trials · doi:10.1016/j.cct.2018.11.007 · Cited by 11 · see citing works
Kao, C., Aranda, S. K., Krishnasamy, M., et al. (2018) · European Journal of Cancer Care · doi:10.1111/ecc.12954 · Cited by 10 · see citing works
Tilch, M., Schranz, M., Moehler, M. H., Labenz, C., Moringlane, A., Schmidt, M., Theobald, M., & Heß, G. (2021) · Journal of Cancer Research and Clinical Oncology · doi:10.1007/s00432-020-03495-1 · Cited by 9 · see citing works
Integrating shared decision making into trial consent: A nested, cluster-randomized trial
Lipstein, E. A., Breslin, M., Dodds, C. M., et al. (2020) · Patient Education and Counseling · doi:10.1016/j.pec.2020.12.018 · Cited by 8 · see citing works
Albrecht, T., & Taylor, A. G. (2013) · Applied Nursing Research · doi:10.1016/j.apnr.2013.05.003 · Cited by 5 · see citing works
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SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials
Hróbjartsson, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · BMJ · doi:10.1136/bmj-2024-081660 · Cited by 171 · see citing works
- Authors
- O'Sullivan Greene, E., & Shiely, F.
- Affiliations
- University College Cork (IE)
- Corresponding author
- Shiely, Frances
- ORCID
- Shiely, Frances
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2022-12
- Volume
- 152
- Pages
- 248-256
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W4306889085
- Cited by
- 11
- References
- 60
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 5 · 2023: 2
- FWCI
- 0.82
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- Journal of Clinical Epidemiology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Health Research Board (TMRN-2017-1, TMRN-2021-001, TMRN-2014-1, CRFC-2021-005)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- clinical trial registries, trial accrual, early trial termination
- MeSH terms
- Clinical Trial Protocols as Topic, Clinical Trials as Topic, Humans, Publications, Registries, Retrospective Studies, Patient Selection
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