AllTrials – Patients’ and doctors’ campaign welcomes plans to tackle unjust and dangerous problem of hidden clinical trials
'The AllTrials campaign, which has been calling for all clinical trials past and present to be registered, and full methods and results made available, today welcomed new proposals by the US Department of Health and Human Services (HHS) and National Institutes of Health (NIH) to expand reporting of clinical trial results, and to make that a condition of research funding, as a significant and potentially transformative step in the battle for clinical trial transparency. Around half of all clinical trials for treatments we use today have never published results and thousands have never even been registered. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated. Hundreds of thousands of patients took part in those trials in the expectation that their results would be used by doctors and researchers to improve understanding of disease and the development of new treatments. HHS has launched a consultation on expanding the scope of the FDA Amendment Act 2007 to include requirements that clinical trials of unlicensed medicines and for off-label uses be registered and report results on ClinicalTrials.gov. NIH has launched a concurrent consultation on requiring all clinical trials it funds to be registered and report results, regardless of whether they are subject to FDAAA ..."