Protocols, probity, and publication

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials

Moher, D., Schulz, K. F., & Altman, D. G. (2001) · The Lancet · doi:10.1016/s0140-6736(00)04337-3 · Cited by 5,373 · see citing works

Selective publication of antidepressant trials and its influence on apparent efficacy

Turner, E. H., Matthews, A. M., Linardatos, E., Tell, R. A., & Rosenthal, R. (2008) · New England Journal of Medicine · doi:10.1056/nejmsa065779 · Cited by 2,435 · see citing works

Requisitos uniformes para manuscritos submetidos a periódicos biomédicos: escrevendo e editando para publicações biomédicas

Munhoz, E. (2006) · Epidemiologia e Serviços de Saúde · doi:10.5123/s1679-49742006000100002 · Cited by 417 · see citing works

Is This Clinical Trial Fully Registered? — A Statement from the International Committee of Medical Journal Editors

Angelis, C. D. D., Drazen, J. M., Frizelle, F., Haug, C. J., Hoey, J., Horton, R. C., Kotzin, S., Laine, C. M., Marušić, A., Overbeke, A. J. P. M., et al. (2005) · New England Journal of Medicine · doi:10.1056/nejme058127 · Cited by 354 · see citing works

Erlotinib and bevacizumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck: a phase I/II study

Cohen, E. E. W., Davis, D. W., Karrison, T. G., Seiwert, T. Y., Wong, S. J., Nattam, S. R., Kozloff, M. F., Clark, J. I., Yan, D., Liu, W., et al. (2009) · The Lancet Oncology · doi:10.1016/s1470-2045(09)70002-6 · Cited by 273 · see citing works

Bias, Spin, and Misreporting: Time for Full Access to Trial Protocols and Results

Chan, A.-W. (2008) · PLoS Medicine · doi:10.1371/journal.pmed.0050230 · Cited by 144 · 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

Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors

Angelis, C. D. D., Drazen, J. M., Frizelle, F., Haug, C. J., Hoey, J., Horton, R. C., Kotzin, S., Laine, C. M., Marušić, A., Overbeke, A. J. P. M., et al. (2005) · The Lancet · doi:10.1016/s0140-6736(05)66588-9 · Cited by 92 · 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

Grim new role for forensic pathologist

Cordner, S. M., & Ranson, D. (1997) · The Lancet · doi:10.1016/s0140-6736(97)90039-8 · Cited by 25 · see citing works

Ethical Considerations in the Interpretation and Communication of Clinical Trial Results

Coultas, D. (2007) · Proceedings of the American Thoracic Society · doi:10.1513/pats.200701-007gc · Cited by 21 · see citing works

Protocol review at The Lancet

McNamee, D., James, A., & Kleinert, S. (2008) · The Lancet · doi:10.1016/s0140-6736(08)61053-3 · Cited by 19 · see citing works

Protocol reviews at The Lancet

McNamee, D. (1997) · The Lancet · doi:10.1016/s0140-6736(05)66237-x · Cited by 15 · see citing works

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

SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

Chan, A., Tetzlaff, J., Altman, D. G., Laupacis, A., Gøtzsche, P. C., A-Jerić, K. K., Hrobjartsson, A., Mann, H., Dickersin, K., Berlin, J. A., et al. (2015) · PubMed · Cited by 209 · 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

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

Li, T., Boutron, I., Salman, R. A.-S., Cobo, E., Flemyng, E., Grimshaw, J. M., & Altman, D. G. (2017) · Trials · doi:10.1186/s13063-016-1743-0 · Cited by 66 · see citing works

Use of guidelines to improve the quality and transparency of reporting oral health research

Sarkis-Onofre, R., Cenci, M. S., Demarco, F. F., Lynch, C. D., Fleming, P. S., Pereira-Cenci, T., & Moher, D. (2015) · Journal of Dentistry · doi:10.1016/j.jdent.2015.01.006 · Cited by 73 · see citing works

Comparison between publicly accessible publications, registries, and protocols of phase III trials indicated persistence of selective outcome reporting

Zhang, S., Liang, F., & Li, W. (2017) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.07.010 · Cited by 41 · see citing works

Role of industry funders in oncology RCTs published in high-impact journals and its association with trial conclusions and time to publication

Liang, F., Zhu, J., Mo, M., Zhou, C., Jia, H., Xie, L., Zheng, Y., & Zhang, S. (2018) · Annals of Oncology · doi:10.1093/annonc/mdy305 · Cited by 41 · see citing works

Availability of study protocols for randomized trials published in high-impact medical journals: A cross-sectional analysis

Spence, O., Hong, K., Onwuchekwa Uba, R., & Doshi, P. (2020) · Clinical Trials · doi:10.1177/1740774519868310 · Cited by 37 · see citing works

Evolution in the eligibility criteria of randomized controlled trials for systemic cancer therapies

Srikanthan, A., Vera-Badillo, F., Ethier, J.-L., Goldstein, R. S., Templeton, A. J., Ocaña, A., Šeruga, B., & Amir, E. (2015) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2015.12.006 · Cited by 35 · see citing works

A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan

Walwyn, R. E. A., Potts, L. C., McCrone, P., Johnson, A. L., DeCesare, J. C., Baber, H., Goldsmith, K., Sharpe, M., Chalder, T., & White, P. D. (2013) · Trials · doi:10.1186/1745-6215-14-386 · Cited by 30 · see citing works

Publishing protocols for trials of complex interventions before trial completion – potential pitfalls, solutions and the need for public debate

Basu, A. P., Pearse, J. E., & Rapley, T. (2017) · Trials · doi:10.1186/s13063-016-1757-7 · Cited by 28 · see citing works

Comparison of Eligibility Criteria Between Protocols, Registries, and Publications of Cancer Clinical Trials

Zhang, S., Liang, F., Li, W., & Tannock, I. F. (2016) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djw129 · Cited by 20 · see citing works

Quality of reporting of phase II trials: a focus on highly ranked oncology journals

Grellety, T., Petit-Monéger, A., Diallo, A., Mathoulin‐Pélissier, S., & Italiano, A. (2014) · Annals of Oncology · doi:10.1093/annonc/mdt550 · Cited by 19 · see citing works

SPIRIT 2013 Bildirisi: Klinik Deneyler İçin Standart Protokol Maddelerinin Tanımlanması

Akın, B., & Koçoğlu, D. (2021) · Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi · doi:10.31125/hunhemsire.908072 · Cited by 17 · see citing works

Online Survey for the Assessment of Generic Health Literacy among Adolescents in Germany (GeKoJu): Study Protocol

Loer, A.-K. M., Domańska, O. M., Kuhnert, R., Houben, R., Albrecht, S., & Jordan, S. (2020) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph17051518 · Cited by 16 · 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

Protocol review at The Lancet: 1997–2015

Lancet, T. (2015) · The Lancet · doi:10.1016/s0140-6736(15)01131-9 · Cited by 10 · see citing works

The clinical trial transparency in oncology significantly increased over the recent years

Song, S. Y., & Kim, E. Y. (2019) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2019.11.018 · Cited by 8 · see citing works

Informed consent: time for more transparency

Yazıcı, Y., & Yazıcı, H. (2010) · Arthritis Research & Therapy · doi:10.1186/ar3004 · Cited by 8 · see citing works

Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis

Sheng, J., Feldhake, E., Zarin, D. A., & Kimmelman, J. (2022) · Med · doi:10.1016/j.medj.2022.03.002 · Cited by 7 · see citing works

Comparison of primary endpoints between publications, registries, and protocols of phase III cancer clinical trials

Liang, F., Guo, X., Zhang, S., Xue, H., Chen, Q., & Hu, X. (2017) · Oncotarget · doi:10.18632/oncotarget.21459 · Cited by 7 · see citing works

Using natural experiments to evaluate population health interventions: a framework for producers and users of evidence

Craig, P., Campbell, M., Deidda, M., Dundas, R., Green, J., Katikireddi, S. V., Lewsey, J., Ogilvie, D., de Vocht, F., & White, M. J. (2025) · Public Health Research · doi:10.3310/jtyw6582 · Cited by 5 · see citing works

Protocols, probity, and publication

Schulz, K. F., Altman, D. G., & Moher, D. (2009) · The Lancet · doi:10.1016/s0140-6736(09)60859-x · Cited by 5 · see citing works

Comparisons between protocols and publications of case-control studies: analysis of potential causes of non-reproducibility and recommendations for enhancing the quality of personalization in healthcare

Hou, H., Ding, G., Zhao, X., Meng, Z., Xu, J., Guo, Z., Zheng, Y., Li, D., & Wang, W. (2019) · The EPMA Journal · doi:10.1007/s13167-019-00165-2 · Cited by 3 · see citing works

Definition and rationale for placebo composition: Cross-sectional analysis of randomized trials and protocols published in high-impact medical journals

Hong, K., Rowhani-Farid, A., & Doshi, P. (2023) · Clinical Trials · doi:10.1177/17407745231167756 · Cited by 1 · see citing works

Ergebnisregister für klinische Studien – ein Meilenstein auf dem Weg zur Transparenz klinischer Forschung?

Wieseler, B. (2010) · Zeitschrift für Evidenz Fortbildung und Qualität im Gesundheitswesen · doi:10.1016/j.zefq.2010.03.031 · Cited by 1 · see citing works

A History of Fraud and Deceit in Medical Research

Salhab, M. (2010) · Surgery Journal · doi:10.3923/sjour.2010.1.6

Improving nutrition research through better methodology: Study protocols now accepted in Clinical Nutrition ESPEN

Sánchez‐Rodríguez, D., Perkisas, S., Prado, C. M. M., & Deutz, N. E. P. (2020) · Clinical Nutrition ESPEN · doi:10.1016/j.clnesp.2020.06.004

Tradução, adaptação transcultural e validação do checklist SPIRIT® para a língua portuguesa falada no Brasil: um estudo qualitativo

Botelho, G. (2020) · doi:10.14393/ufu.te.2021.5005

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

Akın, B., & Koçoğlu, D. (2020) · DergiPark (Istanbul University)

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

¿Estamos preparadas para los nuevos desafíos de la ética de la publicación?

Salcedo, I. (2023) · Metas de Enfermería · doi:10.35667/metasenf.2023.26.1003082104

Nuevas recomendaciones para sostener antiguos valores de responsabilidad y transparencia en publicaciones de revistas médicas

Serra, M. E. (2013) · Archivos Argentinos de Pediatria · doi:10.5546/aap.2013.466 · Cited by 5 · see citing works

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

European Association of Science Editors. www.ease.org.uk

Smart, P., & Maisonneuve, H. (2013)