The National Institutes of Health (NIH) has proposed new
rules that would require researchers to report all the results of clinical
trials of drugs, devices, and other interventions. This proposal comes in
response to mounting concerns that important health data has been kept hidden
from physicians and their patients.
The results of all clinical trials will be fully reported
and included in the NIH’s ClinicalTrials.gov database—regardless of whether the
product is approved or not. The proposed rule would require that all studies of
off-label uses of approved drugs also be publicly reported.
Please write to NIH and thank them for this proposed rule,
and underscore how important it is—for your family’s safety as well as for the
health of future generations.
Thank You for Publishing All Clinical Trial Results!
Dear [Decision Maker],
I was excited to learn that NIH has proposed new rules that would require researchers to report all the results of clinical trials of drugs, devices, and other interventions, and make them publicly available at ClinicalTrials.gov. I'm grateful that you've listened to mounting concerns that important health data has been kept hidden from physicians and their patients.This would make your database a source of important data for future investigations of drugs and devices, and it would ensure that patients who sign up to participate in future clinical trials are fully informed. I was also extremely pleased to see that you're issuing a draft policy that would extend similar registration and reporting requirements to any clinical trial that is even partially funded by the NIH, regardless of whether the trial is otherwise subject to the FDAAA. Greater transparency of study protocols and study results would clearly help to advance medicine. The American public has a right to know the truth about all drug and product trials. It could well make a difference in my family's health and safety, and will certainly benefit the health of future generations. Thank you!
Sincerely,[Your Name] [Your Address] [City, State ZIP]