Data transparency advocates cheered a pair of significant wins in the healthcare/pharma industry this week. For many years, open-access advocates have demanded greater access to the clinical trial data that drug companies generate as part of their research; however, much of that data has remained unavailable.
This week, pharma giant Johnson & Johnson announced that it will share data from its drug, device and diagnostic trials.
Meanwhile, the Institute of Medicine (IOM) released a report suggesting that investigators should be required to establish a data-sharing plan when a trial is initiated and that all clinical trial data should be available no later than 18 months after the last patient visit. The report stated that data underlying a trial analysis should be available six months after publication.
The IOM report doesn't dictate policy in any way, but it's still a strong statement, especially when it's backed up by a company with J&J's market power. Still, it's a tall hill to climb: According to Forbes, there are 182,168 registered trials on ClinicalTrials.gov, and despite a "gradual" increase in reporting, only 15,845 trials posted results last year. According to some estimates, the results of half of all clinical trials have never been published, with positive trials twice as likely to see the light of day as others.
Dr. Bernard Lo, chair of the IOM committee, emphasized the importance of data sharing as a pathway to ensuring that patients continue to want to participate in clinical trials.
"We always want to focus on participants and respect them, because after all, it is their data being used," Lo said. We want to increase public trust in the clinical trials and the sharing of trial data. It’s absolutely essential that the public continues to be willing and actually increase their willingness to participate in clinical trials for the benefit of future patients."
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