Review and publication of protocol submissions to Trials – what have we learned in 10 years?

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

Chan, A.-W., Tetzlaff, J. M., Altman, D. G., Laupacis, A., Gøtzsche, P. C., Krleža-Jerić, K., Hróbjartsson, A., Mann, H., Dickersin, K., Berlin, J. A., et al. (2013) · Annals of Internal Medicine · doi:10.7326/0003-4819-158-3-201302050-00583 · Cited by 7,363 · see citing works

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

International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use

Abraham, J. M. (2010) · Brill | Nijhoff eBooks · doi:10.1163/ej.9789004163300.i-1081.897 · Cited by 2,612 · see citing works

Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials: Comparison of Protocols to Published Articles

Chan, A.-W., Hróbjartsson, A., Haahr, M. T., Gøtzsche, P. C., & Altman, D. G. (2004) · JAMA · doi:10.1001/jama.291.20.2457 · Cited by 1,845 · see citing works

Increasing value and reducing waste: addressing inaccessible research

Chan, A.-W., Song, F., Vickers, A., Jefferson, T., Dickersin, K., Gøtzsche, P. C., Krumholz, H. M., Ghersi, D., & van der Worp, H. B. (2014) · The Lancet · doi:10.1016/s0140-6736(13)62296-5 · Cited by 887 · see citing works

Trial Reporting in ClinicalTrials.gov — The Final Rule

Zarin, D. A., Tse, T., Williams, R. J., & Carr, S. (2016) · New England Journal of Medicine · doi:10.1056/nejmsr1611785 · Cited by 332 · see citing works

Comparison of protocols and registry entries to published reports for randomised controlled trials

Dwan, K., Altman, D. G., Cresswell, L., Blundell, M., Gamble, C. L., & Williamson, P. R. (2011) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.mr000031.pub2 · Cited by 243 · see citing works

Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1)

Krleža-Jerić, K., Chan, A., Dickersin, K., Sim, I., Grimshaw, J., & Gluud, C. N. (2005) · BMJ · doi:10.1136/bmj.330.7497.956 · Cited by 236 · see citing works

The Multicenter Uveitis Steroid Treatment Trial: Rationale, Design, and Baseline Characteristics

Group12⁎, T. M. U. S. T. T. R. (2010) · American Journal of Ophthalmology · doi:10.1016/j.ajo.2009.11.019 · Cited by 214 · see citing works

Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study

Pildal, J., Chan, A.-W., Hróbjartsson, A., Forfang, E., Altman, D. G., & Gøtzsche, P. C. (2005) · BMJ · doi:10.1136/bmj.38414.422650.8f · Cited by 209 · see citing works

Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols

Chan, A.-W., Hrobjartsson, A., Jorgensen, K. J., Gotzsche, P. C., & Altman, D. G. (2008) · BMJ · doi:10.1136/bmj.a2299 · Cited by 202 · see citing works

Toward a New Era of Trust and Transparency in Clinical Trials.

Hudson, K., Lauer, M., & Collins, F. (2016) · Journal of the American Medical Association (JAMA) · doi:10.1001/jama.2016.14668 · Cited by 132 · see citing works

Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet

Al-Marzouki, S., Roberts, I., Evans, S., & Marshall, T. (2008) · The Lancet · doi:10.1016/s0140-6736(08)61060-0 · Cited by 119 · see citing works

Adverse Event Reporting in Publications Compared With Sponsor Database for Cancer Clinical Trials

Scharf, O., & Colevas, A. D. (2006) · Journal of Clinical Oncology · doi:10.1200/jco.2005.05.3959 · Cited by 109 · see citing works

Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols

Mhaskar, R., Djulbegovic, B., Magazin, A., Soares, H. P., & Kumar, A. (2012) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2011.10.016 · Cited by 102 · see citing works

From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology

Raghav, K. P. S., Mahajan, S., Yao, J. C., Hobbs, B. P., Berry, D. A., Pentz, R. D., Tam, A., Hong, W. K., Ellis, L. M., Abbruzzese, J., et al. (2015) · Journal of Clinical Oncology · doi:10.1200/jco.2015.62.4148 · Cited by 59 · see citing works

Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory

Hróbjartsson, A., Pildal, J., Chan, A.-W., Haahr, M. T., Altman, D. G., & Gøtzsche, P. C. (2009) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2009.04.003 · Cited by 56 · see citing works

Reporting of eligibility criteria of randomised trials: cohort study comparing trial protocols with subsequent articles

Blumle, A., Meerpohl, J. J., Rucker, G., Antes, G., Schumacher, M., & von Elm, E. (2011) · BMJ · doi:10.1136/bmj.d1828 · Cited by 44 · see citing works

The power of the protocol

Lassere, M. N., & Johnson, K. R. (2002) · The Lancet · doi:10.1016/s0140-6736(02)11652-7 · Cited by 36 · see citing works

Trial protocols at the BMJ

Jones, G., & Abbasi, K. A. (2004) · BMJ · doi:10.1136/bmj.329.7479.1360 · Cited by 36 · see citing works

Lead editorial: Trials – using the opportunities of electronic publishing to improve the reporting of randomised trials

Altman, D. G., Furberg, C. D., Grimshaw, J., & Rothwell, P. M. (2006) · Trials · doi:10.1186/1745-6215-7-6 · Cited by 33 · see citing works

Pardonable revisions and protocol reviews

Horton, R. (1997) · The Lancet · doi:10.1016/s0140-6736(05)62158-7 · Cited by 31 · see citing works

Protocols, probity, and publication

Summerskill, W., Collingridge, D., & Frankish, H. (2009) · The Lancet · doi:10.1016/s0140-6736(09)60590-0 · Cited by 31 · see citing works

Our Patient Earth

Siegel, J. P. (1990) · New England Journal of Medicine · doi:10.1056/nejm199011083231921 · Cited by 23 · see citing works

From protocol to published report: a study of consistency in the reporting of academic drug trials

Berendt, L., Callréus, T., Petersen, L. G., Bach, K. F., Poulsen, H. E., & Dalhoff, K. (2016) · Trials · doi:10.1186/s13063-016-1189-4 · Cited by 13 · see citing works

Challenges in the design and implementation of the Multicenter Uveitis Steroid Treatment (MUST) Trial – lessons for comparative effectiveness trials

Holbrook, J. T., Kempen, J. H., Prusakowski, N., Altaweel, M. M., & Jabs, D. A. (2011) · Clinical Trials · doi:10.1177/1740774511423682 · Cited by 12 · see citing works

Major journals should peer review trials at protocol stage

Foss, A. J. E., & Westcott, M. C. (1997) · BMJ · doi:10.1136/bmj.314.7095.1691a · Cited by 6 · see citing works

Development of guidance for statistical analysis plans (SAPs) for clinical trials

Krishan, A., Stocken, D. D., Lewis, S. C., Juszczak, E., Doré, C. J., Williamson, P. R., Altman, D. G., Montgomery, A. A., Clarke, M. J., & Gamble, C. L. (2015) · Trials · doi:10.1186/1745-6215-16-s2-o41 · Cited by 5 · see citing works

Update on position and design papers

Goodman, S. N. (2004) · Clinical Trials · doi:10.1191/1740774504cn045ed · Cited by 3 · see citing works

Submission Guidelines

(2016) · Film History · doi:10.2979/filmhistory.28.2.08 · Cited by 1 · see citing works

SPIRIT 2025 statement: updated guideline for protocols of randomised trials

Chan, A.-W., 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-2024-081477 · Cited by 460 · see citing works

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

SPIRIT 2025 statement: updated guideline for protocols of randomized trials

Chan, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, P. G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · Nature Medicine · doi:10.1038/s41591-025-03668-w · Cited by 143 · see citing works

SPIRIT 2025 statement: updated guideline for protocols of randomised trials

Chan, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, P. G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · The Lancet · doi:10.1016/s0140-6736(25)00770-6 · Cited by 111 · see citing works

SPIRIT 2025 Statement

Chan, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, P. G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · JAMA · doi:10.1001/jama.2025.4486 · Cited by 108 · see citing works

Promoting public access to clinical trial protocols: challenges and recommendations

Chan, A.-W., & Hróbjartsson, A. (2018) · Trials · doi:10.1186/s13063-018-2510-1 · Cited by 84 · see citing works

SPIRIT 2025 statement: Updated guideline for protocols of randomised trials

Chan, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, P. G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · PLoS Medicine · doi:10.1371/journal.pmed.1004589 · Cited by 77 · see citing works

The SPIRIT Checklist—lessons from the experience of SPIRIT protocol editors

Qureshı, R., Gough, A., & Loudon, K. (2022) · Trials · doi:10.1186/s13063-022-06316-7 · Cited by 43 · see citing works

Publishers’ Responsibilities in Promoting Data Quality and Reproducibility

Hrynaszkiewicz, I. (2019) · Handbook of experimental pharmacology · doi:10.1007/164_2019_290 · Cited by 36 · see citing works

Justification and reporting of subgroup analyses were lacking or inadequate in randomized controlled trials

Fan, J., Song, F., & Bachmann, M. O. (2019) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2018.12.009 · Cited by 31 · see citing works

Publication of Results of Registered Trials With Published Study Protocols, 2011-2022

Vorland, C. J., Brown, A. W., Halil Kilicoglu, B., Ying, X., & Mayo‐Wilson, E. (2024) · JAMA Network Open · doi:10.1001/jamanetworkopen.2023.50688 · Cited by 20 · see citing works

A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols

Schönenberger, C. M., Griessbach, A., Taji Heravi, A., Gryaznov, D., Gloy, V. L., Lohner, S., Klatte, K., Ghosh, N., Lee, H., Mansouri, A., et al. (2022) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2022.05.014 · Cited by 17 · see citing works

Evaluating the Implementation of Evidence-based Kidney Nutrition Practice Guidelines: The AUGmeNt Study Protocol

Proaño, G. V., Papoutsakis, C., Lamers‐Johnson, E., Moloney, L. M., Bailey, M. M., Abram, J. K., Kelley, K., Steiber, A. L., McCabe, G. P., Myaskovsky, L., et al. (2021) · Journal of Renal Nutrition · doi:10.1053/j.jrn.2021.09.006 · Cited by 14 · see citing works

Conservative versus surgical treatment of foot drop in peroneal nerve entrapment: rationale and design of a prospective, multi-centre, randomized parallel-group controlled trial

Oosterbos, C., Rummens, S., Bogaerts, K., Hoornaert, S., Weyns, F. J. M., Dubuisson, A. S., Lemmens, R., & Theys, T. (2022) · Trials · doi:10.1186/s13063-022-07009-x · Cited by 14 · see citing works

Topiramate versus naltrexone for alcohol use disorder: study protocol for a genotype-stratified, double-blind randomised controlled trial (TOP study)

Morley, K. C., Kranzler, H. R., Luquin, N., Baillie, A., Shanahan, M., Trent, R. J., Teesson, M., & Haber, P. (2018) · Trials · doi:10.1186/s13063-018-2824-z · Cited by 12 · see citing works

Staging and clean room: Constructs designed to facilitate transparency and reduce bias in comparative analyses of real‐world data

Muntner, P., Hernandez, R. K., Kent, S. T., Browning, J. E., Gilbertson, D. T., Hurwitz, K. E., Jick, S. S., Lai, E. C., Lash, T. L., Monda, K. L., et al. (2024) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.5770 · Cited by 11 · see citing works

Study protocol of a randomized controlled trial comparing integrative body–mind–spirit intervention and cognitive behavioral therapy in fostering quality of life of patients with lung cancer and their family caregivers

Lau, B. H. P., Chow, A. Y. M., Wong, D. F. K., Chan, J. S. M., Chan, C., Ho, R., So, T., Lam, T.-C., Lee, V. H.-F., Lee, A. W. M., et al. (2018) · Journal of Evidence-Informed Social Work · doi:10.1080/23761407.2018.1435325 · Cited by 12 · see citing works

Publication trends of study protocols in rehabilitation

Jesus, T. S., & Colquhoun, H. L. (2018) · European Journal of Physical and Rehabilitation Medicine · doi:10.23736/s1973-9087.17.04858-4 · Cited by 10 · see citing works

Aerobic exercise-based cardiac rehabilitation in Chinese patients with coronary heart disease: study protocol for a pilot randomized controlled trial

Cao, R. Y., Zheng, H., Mi, Q., Li, Q., Yuan, W., Ding, Y., & Yang, J. (2018) · Trials · doi:10.1186/s13063-018-2771-8 · Cited by 9 · see citing works

Coproducing an Ecological Momentary Assessment Measurement Burst Mental Health Study With Young People: The MHIM Coproduction Protocol

Power, L., Xie, T., Bartlett, T., Hoxha, D., Bryson, H., Drummond, E., Fairbairn, P., Swan, A., Tan, Y., Caddick, L., et al. (2025) · Health Expectations · doi:10.1111/hex.70218 · Cited by 8 · see citing works

Theta-burst rTMS in schizophrenia to ameliorate negative and cognitive symptoms: study protocol for a double-blind, sham-controlled, randomized clinical trial

Csukly, G., Orbán-Szigeti, B., Suri, K., Zsigmond, R., Hermán, L., Simon, V., Kabaji, A., Bata, B., Hársfalvi, P., Vass, E., et al. (2024) · Trials · doi:10.1186/s13063-024-08106-9 · Cited by 8 · see citing works

Study protocol: short against long antibiotic therapy for infected orthopedic sites — the randomized-controlled SALATIO trials

Uçkay, İ., Wirth, S. H., Zörner, B., Fucentese, S. F., Wieser, K., Schweizer, A., Müller, D. A., Zingg, P. O., & Farshad, M. (2023) · Trials · doi:10.1186/s13063-023-07141-2 · Cited by 7 · see citing works

The FitSpirit approach for increasing physical activity in canadian teenage girls: protocol of a longitudinal, quasi-experimental study

Leduc, G., Gilbert, J., Ayotte, A., Moreau, N., Drapeau, V., Lemoyne, J., Monthuy‐Blanc, J., Tremblay, J., & Mathieu, M.-E. (2021) · BMC Public Health · doi:10.1186/s12889-021-10200-5 · Cited by 7 · see citing works

A Two-Stage Bayesian Sequential Assessment of Exploratory Hypotheses

Stefan, A. M., Lengersdorff, L., & Wagenmakers, E. (2022) · Collabra Psychology · doi:10.1525/collabra.40350 · Cited by 7 · see citing works

Broad-spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery—the prospective-randomized, microbiologist-blinded, stratified, superiority trials: BAPTIST Trials

Uçkay, İ., Bomberg, H., Risch, M., Müller, D. A., Betz, M., & Farshad, M. (2024) · Trials · doi:10.1186/s13063-023-07605-5 · Cited by 6 · see citing works

Protocol publication rate and comparison between article, registry and protocol in RCTs

Mathieu, S., Bouillon‐Minois, J., Triché, L. R., Coudeyre, E., de Chazeron, I., Finotto, T., Laporte, C., Moisset, X., Samalin, L., Villatte, G., et al. (2025) · BMC Medical Research Methodology · doi:10.1186/s12874-025-02471-y · Cited by 7 · see citing works

General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial)

Unterfrauner, I., Bragatto-Hess, N., Studhalter, T., Farshad, M., & Uçkay, İ. (2024) · Trials · doi:10.1186/s13063-024-08173-y · Cited by 5 · see citing works

Volunteering for Infection: Participant Perspectives on a Hepatitis C Virus Controlled Human Infection Model

Eberts, J. D., Zimmer-Harwood, P., Elsey, J. W. B., Fraser-Urquhart, A., & Smiley, T. (2023) · Clinical Infectious Diseases · doi:10.1093/cid/ciad350 · Cited by 5 · see citing works

“Study protocol for the ≥65 years NOrthern jutland Cohort of Fall risk Assessment with Objective measurements (the NOCfao study)”

Villumsen, S., Grarup, B., Christensen, S. W., Palsson, T. S., & Hirata, R. P. (2020) · BMC Geriatrics · doi:10.1186/s12877-020-01535-6 · Cited by 5 · see citing works

Writing for Pediatric Critical Care Medicine: Reporting Clinical Trials Primary Results, Information, and Secondary Content

Tasker, R. C. (2025) · Pediatric Critical Care Medicine · doi:10.1097/pcc.0000000000003784 · Cited by 4 · see citing works

Describing the landscape of nutrition or diet-related randomised controlled trials: meta-research study of protocols published between 2012 and 2022Preprint

Silva, F. M., Adegboye, A. R. A., Curioni, C. C., Gomes, F. D. S., Collins, P. G. S., Kac, G., Cook, J. A., Ismail, L. C., Page, M. J., Khandpur, N., et al. (2023) · medRxiv · doi:10.1101/2023.06.08.23291109 · Cited by 3 · see citing works

Heterogeneity across outcomes in clinical trials on sodium-glucose cotransporter 2 inhibitors in chronic heart failure: a cross-sectional study

Šaler, F., Viđak, M., Tokalić, R., & Puljak, L. (2025) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2025.111685 · Cited by 2 · see citing works

Rivaroxaban in patients with abdominal aortic aneurysm and high-sensitivity C-reactive protein elevation (BANBOO): study protocol for a randomized, controlled trial

Li, J., Ma, S., Jia, X. J., Bu, Y., Zhou, T., Zhang, L., Qiu, M., & Wang, X. (2023) · Trials · doi:10.1186/s13063-023-07461-3 · Cited by 2 · see citing works

Publishing your trial protocols with Acta Oncologica; your contribution to scientific transparency

Nilbert, M. C., & Overgaard, J. (2019) · Acta Oncologica · doi:10.1080/0284186x.2019.1614219 · Cited by 2 · see citing works

Empowerment and mobile technology in the detection and treatment of main cardiovascular risk factors of patients with ischemic stroke or transient ischemic attack: a protocol for a multicenter randomized controlled trial (CARDIOSTROKE)

Lumikari, T., Jukka Putaala, A., Pirinen, J., Kerola, A. M., Sibolt, G., Granroth‐Wilding, H. M. V., Pakarinen, S., Lehto, M., & Nieminen, T. V. M. (2025) · Trials · doi:10.1186/s13063-025-08778-x · Cited by 1 · see citing works

Efficacy and safety of fecal microbiota transplantation in reducing recurrence of colorectal adenomas after endoscopic resection: study protocol for a multicenter, open-label, randomized, no-treatment-controlled trial

Huang, J., Chen, Z., Wang, M., Yang, C., Wang, A., & Chen, Y. (2026) · Trials · doi:10.1186/s13063-026-09740-1 · Cited by 1 · see citing works

Add-on effects of Chinese herbal medicine external application (FZHFZY) to topical urea for mild-to-moderate psoriasis vulgaris: Protocol for a double-blinded randomized controlled pilot trial embedded with a qualitative study

Wang, J., Zhang, C. S., Zhang, A. L., Yu, J., Deng, H., Chen, H., Xue, C. C., & Lu, C. (2024) · PLoS ONE · doi:10.1371/journal.pone.0297834 · Cited by 1 · see citing works

Describing the landscape of nutrition- and diet-related randomized controlled trials: metaresearch study of protocols published between 2012 and 2022

Silva, F. M., Adegboye, A. R. A., Naude, C. E., Curioni, C. C., Gomes, F. D. S., Collins, P. G. S., Kac, G., de Beyer, J. A., Cook, J. A., Ismail, L. C., et al. (2025) · American Journal of Clinical Nutrition · doi:10.1016/j.ajcnut.2025.01.016 · Cited by 1 · see citing works

Pericardiectomy with routine cardiopulmonary bypass: a multicenter, randomized controlled trial

Huang, J.-B., Lu, C.-C., & Wen, Z.-K. (2025) · Trials · doi:10.1186/s13063-025-08843-5 · Cited by 1 · see citing works

Computational Support for Substance Use Disorder Prevention, Detection, Treatment, and RecoveryPreprint

Yarosh, S., Henry, S. B., Borning, A. H., Choudhury, M. D., Lampe, C. A. C., Mynatt, E. D., Schueller, S. M., & Veinot, T. C. (2020) · arXiv (Cornell University) · doi:10.48550/arxiv.2006.13259 · Cited by 4 · see citing works

Study protocol papers: What, why, and how

Mahant, S. (2023) · Journal of Hospital Medicine · doi:10.1002/jhm.13198 · Cited by 1 · see citing works

Left in the dark: the importance of publicly available clinical trial protocols

Braat, S., & Lee, K. J. (2022) · The Medical Journal of Australia · doi:10.5694/mja2.51773

General Skin and Nasal Decolonization with octenisan® Set before and after Elective Orthopedic Surgery in Selected Patients at Elevated Risk for Revision Surgery and Surgical Site Infections - A Single-Center, Unblinded, Superiority, Randomized-Controlled Trial (BALGDEC Trial)Preprint

Unterfrauner, I., Bragatto-Hess, N., Studhalter, T., Farshad, M., & Uçkay, İ. (2023) · Research Square · doi:10.21203/rs.3.rs-2726619/v1

Dermatitis during adjuvant irradiation for breast cancer (DAI-BREAC): a randomized controlled trial investigating whether grade ≥2 dermatitis during radiotherapy for breast cancer can be reduced by a mobile application that reminds patients to perform skin care

Rades, D., Narvaez-Wolf, C. A., Dziggel, L., Staackmann, C., Radtke, M., Timke, C., Kristiansen, C., Duma, M. N., Yu, N. Y., & Janssen, S. (2025) · Trials · doi:10.1186/s13063-025-08800-2

N-acetyl cysteine for the treatment of alcohol use disorder: study protocol for a multi-site, double-blind randomised controlled trial (NAC-AUD study)

Morley, K. C., Arunogiri, S., Connor, J. P., Clark, P. J., Chatterton, M. L., Baillie, A., Slade, T. N., Berk, M., Lubman, D. I., & Haber, P. (2025) · BMJ Open · doi:10.1136/bmjopen-2024-091631

Effect of intravenous lidocaine infusion on postoperative pulmonary complications in patients undergoing minimally invasive esophagectomy: a study protocol of double-center, double-blind, randomized controlled trial

Wang, F., Zhang, H., Peng, X., Liu, M., Wang, H., Song, Y., Xue, J., Zhu, T., & Zhu, Y. (2025) · Trials · doi:10.1186/s13063-025-09213-x

Additional file 3 of General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial)

Unterfrauner, I., Bragatto-Hess, N., Studhalter, T., Farshad, M., & Uçkay, I. (2024) · Figshare · doi:10.6084/m9.figshare.26745782

Additional file 1 of Study protocol: short against long antibiotic therapy for infected orthopedic sites — the randomized-controlled SALATIO trials

Uçkay, I., Wirth, S., Zörner, B., Fucentese, S. F., Wieser, K., Schweizer, A., Müller, D., Zingg, P., & Farshad, M. (2023) · Figshare · doi:10.6084/m9.figshare.22605775

Additional file 2 of The FitSpirit approach for increasing physical activity in canadian teenage girls: protocol of a longitudinal, quasi-experimental study

Leduc, G., Gilbert, J., Ayotte, A., Moreau, N., Drapeau, V., Lemoyne, J., Monthuy‐Blanc, J., Tremblay, J., & Mathieu, M.-E. (2021) · Figshare · doi:10.6084/m9.figshare.13662480

Additional file 1 of Broad-spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery—the prospective-randomized, microbiologist-blinded, stratified, superiority trials: BAPTIST Trials

Uçkay, I., Bomberg, H., Risch, M., Müller, D. A., Betz, M., & Farshad, M. (2024) · Figshare · doi:10.6084/m9.figshare.25034419

Additional file 1 of Conservative versus surgical treatment of foot drop in peroneal nerve entrapment: rationale and design of a prospective, multi-centre, randomized parallel-group controlled trial

Oosterbos, C., Rummens, S., Bogaerts, K., Hoornaert, S., Weyns, F. J. M., Dubuisson, A. S., Lemmens, R., & Theys, T. (2023) · Figshare · doi:10.6084/m9.figshare.22598941

Additional file 3 of Broad-spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery—the prospective-randomized, microbiologist-blinded, stratified, superiority trials: BAPTIST Trials

Uçkay, I., Bomberg, H., Risch, M., Müller, D. A., Betz, M., & Farshad, M. (2024) · Figshare · doi:10.6084/m9.figshare.26669793

Additional file 1 of General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial)

Unterfrauner, I., Bragatto-Hess, N., Studhalter, T., Farshad, M., & Uçkay, I. (2024) · Figshare · doi:10.6084/m9.figshare.26211252

Additional file 2 of Conservative versus surgical treatment of foot drop in peroneal nerve entrapment: rationale and design of a prospective, multi-centre, randomized parallel-group controlled trial

Oosterbos, C., Rummens, S., Bogaerts, K., Hoornaert, S., Weyns, F. J. M., Dubuisson, A. S., Lemmens, R., & Theys, T. (2023) · Figshare · doi:10.6084/m9.figshare.22598944

Additional file 1 of The FitSpirit approach for increasing physical activity in canadian teenage girls: protocol of a longitudinal, quasi-experimental study

Leduc, G., Gilbert, J., Ayotte, A., Moreau, N., Drapeau, V., Lemoyne, J., Monthuy‐Blanc, J., Tremblay, J., & Mathieu, M.-E. (2021) · Figshare · doi:10.6084/m9.figshare.13662477

Additional file 2 of General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial)

Unterfrauner, I., Bragatto-Hess, N., Studhalter, T., Farshad, M., & Uçkay, I. (2024) · Figshare · doi:10.6084/m9.figshare.26211621

Additional file 1 of Theta-burst rTMS in schizophrenia to ameliorate negative and cognitive symptoms: study protocol for a double-blind, sham-controlled, randomized clinical trial

Csukly, G., Orbán-Szigeti, B., Suri, K., Zsigmond, R., Hermán, L., Simon, V., Kabaji, A., Bata, B., Hársfalvi, P., Vass, E., et al. (2024) · Figshare · doi:10.6084/m9.figshare.25632906

Additional file 1 of Rivaroxaban in patients with abdominal aortic aneurysm and high-sensitivity C-reactive protein elevation (BANBOO): study protocol for a randomized, controlled trial

Li, J., Ma, S., Jia, X. J., Bu, Y., Zhou, T., Zhang, L., Qiu, M., & Wang, X. (2023) · Figshare · doi:10.6084/m9.figshare.23542921

Additional file 3 of Study protocol: short against long antibiotic therapy for infected orthopedic sites — the randomized-controlled SALATIO trials

Uçkay, I., Wirth, S., Zörner, B., Fucentese, S. F., Wieser, K., Schweizer, A., Müller, D. A., Zingg, P., & Farshad, M. (2023) · Figshare · doi:10.6084/m9.figshare.22605781

Additional file 2 of Broad-spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery—the prospective-randomized, microbiologist-blinded, stratified, superiority trials: BAPTIST Trials

Uçkay, I., Bomberg, H., Risch, M., Müller, D. A., Betz, M., & Farshad, M. (2024) · Figshare · doi:10.6084/m9.figshare.25034521

Additional file 3 of Conservative versus surgical treatment of foot drop in peroneal nerve entrapment: rationale and design of a prospective, multi-centre, randomized parallel-group controlled trial

Oosterbos, C., Rummens, S., Bogaerts, K., Hoornaert, S., Weyns, F. J. M., Dubuisson, A. S., Lemmens, R., & Theys, T. (2023) · Figshare · doi:10.6084/m9.figshare.22598947

Additional file 2 of Study protocol: short against long antibiotic therapy for infected orthopedic sites — the randomized-controlled SALATIO trials

Uçkay, I., Wirth, S., Zörner, B., Fucentese, S. F., Wieser, K., Schweizer, A., Müller, D., Zingg, P., & Farshad, M. (2023) · Figshare · doi:10.6084/m9.figshare.22605778

Study Protocol: PICO Negative Pressure for the Treatment of Uninfected Foot Ulcers and Wound Dehiscence - an unblinded, randomized-controlled, superiority trial (BALPIC Trial)Preprint

Zendeli, F., Richner, D., Sauer, R., Frustaci, D., Waibel, F. W. A., Gautier, L., Hasler, A., Wolf‐Wettstein, J., Rätzo, L., & Uçkay, İ. (2026) · Research Square · doi:10.21203/rs.3.rs-8994481/v1

Writing, Reviewing, and Reading Standard and Pragmatic Clinical Trial Protocol Papers

Munroe, E. S., Patel, B. K., & Peltan, I. D. (2026) · CHEST Critical Care · doi:10.1016/j.chstcc.2026.100311

Discrepancies in reporting of study design and analysis methods between protocols and reports of interrupted time series (ITS) studies: a methodological study

Nguyen, P.-Y., Korevaar, E., Page, M. J., McKenzie, J. E., & Turner, S. L. (2026) · BMC Medical Research Methodology · doi:10.1186/s12874-026-02959-1

Trial protocols: time for more than tinkering

Penston, J. G. (2005) · BMJ · doi:10.1136/bmj.330.7488.421-b · Cited by 1 · see citing works

Lead editorial: Trials – using the opportunities of electronic publishing to improve the reporting of randomised trials

Altman, D. G., Furberg, C. D., Grimshaw, J., & Rothwell, P. M. (2006) · Trials · doi:10.1186/1745-6215-7-6 · Cited by 33 · see citing works

Trial protocols

West, R. (2012) · Addiction · doi:10.1111/j.1360-0443.2012.03989.x · Cited by 8 · see citing works

Editorial from our Incoming Editor in Chief: Introducing Open Peer Review, Streamlined Review, and a Trial of the Registered Report Format

Field, S. M., Gaillard, S. D. M., Grüning, D. J., & Visser, J. (2024) · Journal of Trial and Error · doi:10.36850/1367-415f

Linked publications from a single trial: a thread of evidence

Altman, D. G., Furberg, C. D., Grimshaw, J., & Shanahan, D. R. (2014) · Trials · doi:10.1186/1745-6215-15-369 · Cited by 24 · see citing works