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. |