Tough New Medical Research Rules Strive For Clarity In Previously ‘Opaque’ World
The new rules are designed to make it easier for researchers to understand what experiments must be included in the federal database. "This has been a very opaque world up until to now," Food and Drug Commissioner Robert Califf said. "These are tremendous changes."
NPR:
New Rules Aimed To Make Clinical Trials Safer, More Effective
Universities and drug companies that use human volunteers for research face tough new rules designed to make sure that valuable information from these volunteers is widely available, not only to the volunteers themselves but to scientists trying to advance medical science. The rules currently on the books are confusing and often ignored. (Harris, 9/16)
The Washington Post:
Medical Researchers Will Have To Share More Data More Quickly
The government unveiled new policies Friday designed to make findings from clinical trials of therapies and devices more widely available, warning that it would block future funding for universities and other institutions that do not comply. The updated rules are designed to encourage more participation in research studies and to spread the results of those efforts faster and more completely to the patients, physicians and clinical investigators who need them. Officials also described them as an effort to enforce the pact with volunteers in medical experiments that they or others will someday benefit from their participation in research. (Bernstein, 9/16)
Stat:
Clinical Trial Rules Aim To Improve Public Reporting Of Results
Researchers will have to publicly report the results of many more clinical trials, including some for drugs and devices that never reach the market, under new government rules announced Friday. The federal rules, which also require more complete reporting of deaths, clarify and strengthen a 2007 law that requires researchers to report results of many human studies of experimental treatments for ailments such as diabetes, cancer, and heart disease. (Piller, 9/16)
