The FDA is drafting new guidelines on writing consent forms for those who run clinical trials. The consent forms need to ensure patients have the information they need to make an informed decision about participating in a trial. This includes details about the clinical trial, the risks and benefits of participating in the trial, how patient confidentiality will be protected and payment for participating in the trial. The guidance also says that patients should be given summary results of their trial “in a clear and comprehensible manner” and that certain trials need to be registered and report results to ClinicalTrials.gov.
But the FDA’s proposals don’t include anything on allowing trial sponsors to share anonymised data from the trial participants. Some pharmaceutical companies already claim that they can’t share more information from their clinical trials because consent forms didn’t explicitly include this. Not encouraging people running trials to include a note on sharing information, which patients want and actually expect to happen, is a betrayal of the patients’ trust and might even damage medical research.
The value of sharing individual patient data has been proven time and again. Scientists have been reviewing patient data from trials since the 1970s and those reviews have led to many medical advances including better survival rates from chemotherapy, improved heart disease treatments and higher childhood cancer survival rates.
Some pharmaceutical companies have already begun to allow independent researchers to access data from their clinical trials. Johnson & Johnson announced in January that they were giving all of their data to researchers at Yale University. Bristol-Meyers Squibb announced a collaboration with researchers at Duke University to grant access to its clinical trial data in June. GSK, Boehringer Ingelheim, Novartis, Roche, ViiV Healthcare, Sanofi and Eli Lilly share data through ClinicalStudyDataRequest.com.