Feature
Show Me the Money?
Show Us the Data
How will NIH’s new requirement that federally funded
clinical trials report outcomes affect researchers?
The merits and cautions of data sharing
have long been a topic of lively debate in the
research community, but in the case of feder-
ally funded clinical trials, data sharing will no
longer be optional.
In September 2016, the U.S. Department
of Health and Human Services (HHS) and the
National Institutes of Health (NIH) issued new
requirements for registering and reporting
results from clinical trials of drug and biologic
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products on ClinicalTrials.gov, including re-
porting summary results to the public. 1,2
The new NIH policy, which went into effect
January 18, 2017, applies to all trials funded by
NIH – including phase I studies and clinical
trials of behavioral interventions and prod-
ucts not regulated by the U.S. Food and Drug
Administration (FDA).
With these regulations, HHS and NIH
reinforced their commitment to improving
clinical research practice and trial design,
expanding the evidence base that informs
clinical care, building public trust of clinical
research, and increasing the number of patients
who participate in trials. 1,2
“We want to make sure that everyone – the
patient and participant community, the scien-
tists – has the maximal access to information
about the trials and, ultimately, the results,”
Carrie D. Wolinetz, PhD, associate director
June 2017