FAIR reporting of clinical trials for public health practice

<a href="https://www.vecteezy.com/free-vector/banner">Banner Vectors by Vecteezy</a>
Submitted: December 12, 2023
Accepted: April 10, 2024
Published: May 6, 2024
Abstract Views: 805
PDF: 105
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

Authors

The number of clinical trials is rapidly growing, and automation of literature processing is becoming desirable but unresolved. Our purpose was to assess and increase the readiness of clinical trial reports for supporting automated retrieval and implementation in public health practice. We searched the Medline database for a random sample of clinical trials of HIV/AIDS management with likely relevance to public health in Africa. Five authors assessed trial reports for inclusion, extracted data, and assessed quality based on the FAIR principles of scientific data management (findable, accessible, interoperable, and reusable). Subsequently, we categorized reported results in terms of outcomes and essentials of implementation. A sample of 96 trial reports was selected. Information about the tested intervention that is essential for practical implementation was largely missing, including personnel resources needed 32·3% (.95 CI: 22·9-41·6); material/supplies needed 33·3% (.95 CI: 23·9-42·8); major equipment/building investment 42·8% (CI: 33·8-53·7); methods of educating providers 53·1% (CI: 43·1-63·4); and methods of educating the community 27·1% (CI: 18·2-36·0). Overall, 65% of studies measured health/biologic outcomes, among them, only a fraction showed any positive effects. Several specific design elements were identified that frequently make clinical trials unreal and their results unusable. To sort and interpret clinical trial results easier and faster, a new reporting structure, a practice- and retrieval-oriented trial outline with numeric outcomes (PROTON) table was developed and illustrated. Many clinical trials are either inconsequential by design or report incomprehensible results. According to the latest expectations of FAIR scientific data management, all clinical trial reports should include a consistent and practical impact-oriented table of clinical trial results.

Dimensions

Altmetric

PlumX Metrics

Downloads

Download data is not yet available.

Citations

National Library of Medicine. ClinicalTrials.Gov: Trends, Charts, and Maps. 2021. Available from: https://classic.clinicaltrials.gov/ct2/resources/trends
Ioannidis JP, Caplan AL, Dal-Ré R. Outcome reporting bias in clinical trials: why monitoring matters. BMJ 2017;356:j405. DOI: https://doi.org/10.1136/bmj.j408
Bastian H, Glasziou P, Chalmers I. Seventy-five trials and eleven systematic reviews a day: how will we ever keep up? PLoS Med 2010;7:e1000326. DOI: https://doi.org/10.1371/journal.pmed.1000326
Fauci AS, Redfield RR, Sigounas G, Weahkee MD, Giroir BP. Ending the HIV epidemic: a plan for the United States. JAMA 2019;321:844-5. DOI: https://doi.org/10.1001/jama.2019.1343
Alleyne G, Beaglehole R, Bonita R. (2015). Quantifying targets for the SDG health goal. Lancet 2015;385:208-9. DOI: https://doi.org/10.1016/S0140-6736(14)61655-X
Omran D, Alboraie M, Zayed RA, et al. Towards hepatitis C virus elimination: Egyptian experience, achievements and limitations. World J Gastroenterolo 2018;24:4330. DOI: https://doi.org/10.3748/wjg.v24.i38.4330
Ministry of Health of the United Republic of Tanzania. National Aids Control Programme National Guidelines For The Management of HIV And AIDS. 2017. Available from: https://platform.who.int/docs/default-source/mca-documents/policy-documents/guideline/TZA-RH-43-02-GUIDELINE-2017-eng-National-Guidelines-for-Management-of-HIV-and-AIDS-2017-AR.pdf
Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010;152:726-32. DOI: https://doi.org/10.7326/0003-4819-152-11-201006010-00232
Kodounis M, Liampas IN, Constantinidis TS, et al. Assessment of the reporting quality of double-blind RCTs for ischemic stroke based on the CONSORT statement. J Neurol Sci 2020;415:116938. DOI: https://doi.org/10.1016/j.jns.2020.116938
Lee SY, Teoh PJ, Camm CF, Agha RA. Compliance of randomized controlled trials in trauma surgery with the CONSORT statement. J Trauma Acute Care Surg 2013;75:562-72. DOI: https://doi.org/10.1097/TA.0b013e3182a5399e
Liampas I, Chlinos A, Siokas V, Brotis A, Dardiotis E. Assessment of the reporting quality of RCTs for novel oral anticoagulants in venous thromboembolic disease based on the CONSORT statement. J Thromb Thrombolysis 2019;48:542-53. DOI: https://doi.org/10.1007/s11239-019-01931-9
Wang LL, Lo K, Chandrasekhar Y, et al. Cord-19: The covid-19 open research dataset. ArXiv 2004:10706v4.
Wilkinson MD, Dumontier M, Aalbersberg IJ, et al. The FAIR Guiding Principles for scientific data management and stewardship. Sci Data 2016;3:160018. DOI: https://doi.org/10.1038/sdata.2016.18
Dwan K, Gamble C, Williamson PR, Kirkham JJ, Group RB. Systematic review of the empirical evidence of study publication bias and outcome reporting bias—an updated review. PloS One 2013;8:e66844. DOI: https://doi.org/10.1371/journal.pone.0066844
Ioannidis JP. Clinical trials: what a waste. BMJ 2014;349:g7089. DOI: https://doi.org/10.1136/bmj.g7089
Begley CG, Ellis LM. Raise standards for preclinical cancer research. Nature 2012;483:531-3. DOI: https://doi.org/10.1038/483531a

How to Cite

Balas, E. A., Bussi, B. S., Asem, N., Amour, C., Mwanziva, C., Vasquez, J., Labib, N. A., Price, M., Mahande, M. J., Baskar, R., Dhantu, S., Townsend, T. G., & Aubert, C. (2024). FAIR reporting of clinical trials for public health practice. Proceedings of the European Academy of Sciences and Arts, 3. https://doi.org/10.4081/peasa.19