Acta Oncologica is now launching a possibility to submit study protocols for peer-review and publication. As a broad oncology journal engaged in scholarly communication, we take this step to further contribute to scientific transparency and stringency [Citation1]. Acta Oncologica thereby provides a platform to make relevant information on study rationale, design, planned analyses and endpoints publicly available to readers, investigators and prospective participants.
All clinical studies are defined in a protocol, but the completeness and consistency of such protocols compared to the final study publications have been demonstrated to be suboptimal [Citation2–4]. Clinical study registration, e.g., at ClinicalTrials.gov or the World Health Organization International Clinical Trials Registry Platform, has greatly improved transparency in clinical research [Citation5]. Publishing study protocols further improves this aspect since it makes important information on e.g., study rationale, design, planned analyses, and endpoints openly available [Citation6,Citation7]. This area develops rapidly and it is encouraging to experience positive trends for the quantity as well as the quality of published study protocols [Citation8].
Acta Oncologica has a long tradition of publishing results from clinical trials, but publishing study protocol will be new to us. Trial protocols should be submitted close to the start of recruitment to contribute to availability of useful information. Relevant ethical review should be available and data collection in the study must not be completed.
Acta Oncologica endorses the SPIRIT guidelines for intervention trials, which implies that study protocol manuscripts should provide sufficient detail to enable understanding of the background, rationale, objectives, study population, interventions, methods, statistical analyses, ethical considerations, dissemination plans, and administration of the trial [Citation9]. A SPIRIT manuscript checklist may be used to guide to overall organization of the manuscript and should be provided as a supplementary file. Study protocols need to balance conciseness and comprehension with sufficient detail without the extensive details that are required in a study manual.
Acta Oncologica accepts trial protocol manuscripts with a limit of 2000 words, two original tables or figures and possibility for Supplementary data. Authors are encouraged to provide an overview of the trial such as principles for enrollment and points of investigations and interventions in figure format. Study performance or results should typically not be included. Statistical analyses plans that contribute to responsible and transparent data handling may be uploaded as supplementary files.
The editorial team of Acta Oncologica enters this field with the ambition to promote scholarly communication, improve scientific reporting on ongoing studies, and contribute to clinical research efficacy through fewer replicative studies. To all of our readers with planned or ongoing clinical studies, in particular randomized trials, welcome to submit you study protocols for publication in Acta Oncologica.
Disclosure statement
No potential conflict of interest was reported by the authors.
References
- Glimelius B. Forty-five years in oncology, 25 years with Acta Oncologica. Acta Oncol. 2018;57:1593–1598.
- Chan AW, Hróbjartsson A, Haahr MT, et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004;291:2457–2465.
- Dwan K, Altman DG, Cresswell L, et al. Comparison of protocols and registry entries to published reports for randomised controlled trials. Cochrane Database Syst Rev. 2011;1:MR000031.
- Goldacre B, Drysdale H, Dale A, et al. COMPare: a prospective cohort study correcting and monitoring 58 misreported trials in real time. Trials. 2019;20:118.
- Viergever FC, Li K. Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013. BMJ Open. 2015;5:e008932.
- Li T, Boutron I, Al-Shahi Salman R, et al. Review and publication of protocol submissions to trials – What have we learned in 10 years? Trials. 2016;18:34.
- Calméjane L, Dechartres A, Tran VT, et al. Making protocols available with the article improved evaluation of selective outcome reporting. J Clin Epidemiol. 2018;104:95–102.
- van Rosmalen BV, Alldinger I, Cieslak KP, et al. Worldwide trends in volume and quality of published protocols of randomized controlled trials. PLoS One. 2017;12:e0173042.
- Chan A-W, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:7586.