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The main product of the CONSORT Group is the CONSORT Statement, [1] which is an evidence-based, minimum set of recommendations for reporting randomized trials.It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, reducing the influence of bias on their results, and aiding their critical appraisal and interpretation.
The COVID-19 Clinical Research Coalition has goals to 1) facilitate rapid reviews of clinical trial proposals by ethics committees and national regulatory agencies, 2) fast-track approvals for the candidate therapeutic compounds, 3) ensure standardised and rapid analysis of emerging efficacy and safety data, and 4) facilitate sharing of ...
The EQUATOR Network developed and maintains a comprehensive library that provides a collection of publications related to reporting guidelines on scientific writing, empirical evidence supporting or refuting the inclusion of crucial items in reporting guidelines, evaluations of the quality of reporting, publication ethics and educational materials and tools for editors, peer reviewers and ...
In October 2021, the TOGETHER trial, a large clinical trial in Brazil, reported that treating high-risk outpatients with an early diagnosis of COVID-19 with 100 mg fluvoxamine twice daily for 10 days reduced by up to about 65% the risk of hospitalization. The effect was reduced to about 32% with low adherence, possibly due to intolerance.
In November 2020, a U.S. National Institutes of Health clinical trial evaluating the safety and effectiveness of hydroxychloroquine for the treatment of adults with COVID-19 formally concluded that the drug provided no clinical benefit for COVID-19 treatment and recommended against its use. [56] [57] [1]
Other general rules, such as the regulations for clinical trials involving human subjects in 21CFR50, may also apply. [citation needed] In addition to these laws and guidelines, CBER also publishes guidance documents. These are not requirements, but are generally followed by industry.
Human challenge studies have ethical considerations because participants are often at risk of serious adverse effects, including death. There are many examples of trials that were problematic or abusive, such as trials on captives under the Nazi regime in Germany or trials with questionable consent procedures in Guatemala by U.S. doctor John Charles Cutler, who also conducted the Tuskegee ...
The aim of the PRISMA statement is to help authors improve the reporting of systematic reviews and meta-analyses. [3] PRISMA has mainly focused on systematic reviews and meta-analysis of randomized trials, but it can also be used as a basis for reporting reviews of other types of research (e.g., diagnostic studies, observational studies).