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. 2012 Jan;102(1):72–80. doi: 10.2105/AJPH.2011.300187
Policy Purpose
Uniform and complete disclosure of clinical trial investigator relationships and support from industry along with industry sponsorship of clinical trial research. Provide comprehensive information for physicians, patients, and regulators about potential conflicts of interest and sources of bias for consideration when evaluating the clinical trial design, conduct, and findings.
Uniform and complete disclosure of clinical trial investigator contributions to trial design, conduct, and dissemination for all investigators, regardless of industry affiliation. Provide comprehensive information for physicians, patients, and regulators about investigator roles and sources of bias for consideration when evaluating the clinical trial design, conduct, and findings.
Public registration of all human participant clinical trials, including registration of the study design and intervention, enrollment targets and sample size calculation, participant inclusion and exclusion criteria, primary and secondary outcomes, and prespecified primary, secondary, and subgroup analyses. Identify trials that had previously been conducted but never published, as well as trials that deviate from protocol, reporting a secondary outcome as primary or not reporting certain outcomes to include and inform systematic reviews and evidence-based practice guidelines.
Making participant-level clinical trial data available for independent analysis. Complement or validate key findings reported by industry or academic clinical trial researchers, as well as promote public use of data collected in the spirit of science that contributes to public knowledge to improve public understanding of drug or device efficacy and safety.