The Low-Down: Should Clinical Pharma Trial Data Be Made Public?

" ... The proportion of trials that remains unpublished is hard to estimate but may be as much as half. Negative results are naturally less likely to be published than positive ones — skewing the whole evidence base underlying medical practice. The much needed drive to open the results of clinical trials to public scrutiny is gathering momentum. Last week 85 institutional investors threw their weight behind activists demanding more transparency in pharmaceutical research; this week 50 patient and medical organisations in the US will add their voices to the international AllTrials campaign.At issue is the longstanding failure by researchers, in industry and universities, routinely to release the results of studies in which people are subjected to experimental drugs and other medical interventions. The proportion of trials that remains unpublished is hard to estimate but may be as much as half. Negative results are naturally less likely to be published than positive ones — skewing the whole evidence base underlying medical practice. While regulators such as the US Food and Drug Administration and European Medicines Agency receive details of all clinical data used to support applications to introduce new drugs, these are not routinely released for scrutiny by the wider world of medicine and academia. And trials of failed and abandoned drugs may not even reach the regulators, let alone the outside world, although understanding the reasons for failure could help scientists to develop safer and more effective medicines in future ..."