The first clarifies the process for researchers to submit summaries of trial results to the public database at ClinicalTrials.gov. The second motion would expand the current rules to include submissions for trials of unapproved medical products, not just those cleared by the Food and Drug Administration (FDA).
As of now, most clinical trial results are never made public. The new rules would ensure that the results of trials by drug companies and universities are made available quickly.
The proposed guidelines are a boon for consumer advocacy. Supporters say they will help hold pharmaceutical companies and research organizations accountable.
Clarity in Clinical Trials
According to the National Institutes of Health (NIH), ClinicalTrials.gov currently contains registration information for more than 178,000 clinical trials, but summary results for just 15,000.
The addition of previously unavailable trial summaries would greatly increase the amount of information in the database. It would offer the public a look at what happens before a product hits store shelves, even if the trial process was unsuccessful.
“This proposed rule would close an important gap, making additional information about clinical studies of investigational drugs, medical devices, and biological products available to the public,” said FDA Commissioner Dr. Margaret Hamburg in a press release. “It would help eliminate unnecessary duplicative trials, advance biomedical innovation, and provide the public with a much richer understanding about the clinical trials for these products.”
Major Changes in Trial Disclosure
The NIH outlined several significant changes to the current clinical trial reporting system. They include:
- an efficient way to determine which trials fall under the proposed rules and who is responsible for submitting required information
- additional data that must be submitted when registering a trial
- faster public updates about clinical trials
- rules for timely corrections of errors in trial submissions
Why Does This Matter?
Safety is paramount when creating drugs and medical devices. Without public scrutiny, it’s possible for poorly designed trials to slip through the cracks.
The proposal would benefit not only consumers, but another important group: the participants in these trials who volunteer themselves for research. Many never know the outcome of the trials they take part in.
“Medical advances would not be possible without participants in clinical trials,” said NIH director Dr. Francis Collins in a press release. “We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health. This important commitment from researchers to research participants must always be upheld.”