Clinical trials are the main stream of developing and then getting necessary approvals for drugs to be able to make it to market. Drug companies, like every other company and every individual want only to have successes.
We all also have egos and when there is a failure we often prefer to bury that information so that it doesn’t reflect poorly on us. This is human nature and it can serve as an economic driver for drug companies.
When clinical trials do fail this information is most often not reported. Also, sometimes when trials do succeed the information, for various reasons, is also buried!
Not disclosing clinical trial results, whether positive or negative, hurts patients, research funders and researchers. Hopefully, this will change as of January 18, 2016! Our current system
We have just found out that the Obama administration will be publishing new rules pertaining to the public disclosure of clinical trial results. These rules will allow both doctors and patients learn if clinical trials of treatments worked or not.
At issue is very simple. We need better ways to help people find medical studies that may be appropriate for them and to make the results of trials public so that successes can reach patients more quickly and what fails isn’t duplicated, wasting untold time and money.
We can thank Vice President Biden’s Cancer Moon Shot for calling attention to this problem and then moving the Obama administration to make these new rules. Vice President Joe Biden has on many occasions cited concern that secrecy about clinical trial results was stifling cancer progress.
An analysis of 400 studies involving a variety of diseases, including cancer, found 30 percent of the trials completed hadn’t disclosed results within four years of their completion! “That’s clearly unacceptable,” said Dr. Francis Collins, director of the National Institutes of Health.
The new rues which will be posted this coming Friday will make it clear exactly what kinds of studies must be listed on the www.clinicaltrial.gov website so potential participants can consider enrolling. The rules will also specify which trials must post their results as well as by certain deadlines.
Collins pointed out that, “It does in fact have some teeth”. The rules do specify that researchers that don’t meet the requirements for reporting results may face fines or lose taxpayer grants.
Malecare actively supports such rule changes and thanks the Vice President, the Cancer Moon Shot and the president for their stepping up to the plate and issuing these rules.