In the era of big data, the industry is working to address the ethical concerns of integrating patient information into the health care landscape – though a key challenge will be reaching a consensus on what constitutes reliable evidence.
The FDA recently released a draft guidance address penalties for those not disclosing clinical trial results, as patients, the scientific community, and other stakeholders call for increased transparency.
The recent FDA guidance ties penalties for not disclosing clinical trial results to formal inspections – falling short of the public expectation that such data should be readily available, says industry expert.
GlaxoSmithKline has selected TrialScope to facilitate clinical trial disclosure and transparency – as the benefits of patient centricity are paramount, and the risks of poor compliance magnified, says VP.
In an open letter to the US Food and Drug Administration (FDA) AllTrials implores the agency to fine clinical trial sponsors that don’t publish trial results on ClinicalTrials.gov – as no fines have been issued to date.