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• W4303520797 abstract "Many times, faced with a patient and a clinical question, we have wished for a randomized controlled trial (RCT) with a good methodology to address this question. Such trials were often not conducted or were conducted with a bad methodology or outcomes that do not matter to patients. Most clinical decisions are not supported by evidence [[1]Ebell M.H. Sokol R. Lee A. Simons C. Early J. How good is the evidence to support primary care practice?.Evid Based Med. 2017; 22: 88-92https://doi.org/10.1136/ebmed-2017-110704Crossref PubMed Scopus (36) Google Scholar]. Explanations for that abound: RCTs are very expensive. Involvement of industry is required, and industry is not interested in addressing comparison between two old drugs, comparison with other novel agents or exploring treatment durations. The outcomes that matter to patients are seldom chosen because well-validated outcomes are lacking, regulatory bodies have specified other outcome, and often the outcomes that matter increase the sample size and the cost of the trial. Competitive grant sources seldom support RCTs. These rationalizations might not be true. A random sample of RCTs published in 2017 showed funding by the industry in only a third [[2]Turjeman A. Poran I. Daitch V. Tau N. Ayalon-Dangur I. Nashashibi J. et al.Inadequate reporting of participants eligible for randomized controlled trials - a systematic review and meta-analysis.J Clin Epidemiol. 2021; 140: 125-134https://doi.org/10.1016/j.jclinepi.2021.09.006Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar]. Only a minority of trials on intensive care were supported by the industry [[3]Janiaud P. Cristea I.A. Ioannidis J.P.A. Industry-funded versus non-profit-funded critical care research: a meta-epidemiological overview.Intensive Care Med. 2018; 44: 1613-1627https://doi.org/10.1007/s00134-018-5325-3Crossref PubMed Scopus (14) Google Scholar]. Researcher-initiated RCTs addressing questions that matter to patients can be conducted, and are cheaper than industrial trials [[4]Paul M. Harbarth S. Huttner A. Thwaites G.E. Theuretzbacher U. Bonten M.J.M. et al.Investigator-initiated randomized controlled trials in infectious diseases: better value for money for registration trials of new antimicrobials.Clin Infect Dis. 2021; 72: 1259-1264https://doi.org/10.1093/cid/ciaa930Crossref PubMed Scopus (5) Google Scholar]. Some of these were conducted on internal resources only [[4]Paul M. Harbarth S. Huttner A. Thwaites G.E. Theuretzbacher U. Bonten M.J.M. et al.Investigator-initiated randomized controlled trials in infectious diseases: better value for money for registration trials of new antimicrobials.Clin Infect Dis. 2021; 72: 1259-1264https://doi.org/10.1093/cid/ciaa930Crossref PubMed Scopus (5) Google Scholar]. We invite you to describe in a Clinical Microbiology and Infection (CMI) Commentary an RCT that has not been conducted and should be performed to answer a clinical question that matters to your patients. Tell us why it was not done before, and propose how the obstacles can be overcome. Please describe the clinical question in terms of population, intervention, comparison, main and secondary outcomes, and the design of your ‘dream’ trial. Such RCTs might address the comparison of one antimicrobial drug to another or one treatment strategy to another; combinations of drugs to monotherapy; a special population or one pathogen; a group of pathogens with a common resistance mechanism; or different durations of treatment. They may ask whether the employment of a diagnostic test or strategy improved the patients' outcome. You might want to present a methodology that should be employed or outcomes that matter to the participants. Please use the CMI format of a Commentary (see CMI Guide for Authors: https://www.elsevier.com/journals/clinical-microbiology-and-infection/1198-743X/guide-for-authors), CMI commentaries are 1200–1400 words long, 12–14 references. Hopefully your piece will encourage people to conduct the trial. not peer reviewed." @default.
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• W4303520797 date "2022-12-01" @default.
• W4303520797 modified "2023-10-16" @default.
• W4303520797 title "Which randomized controlled trial do we need?" @default.
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• W4303520797 doi "https://doi.org/10.1016/j.cmi.2022.10.008" @default.
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