AllTrials contd. Unpublished Trial Data Violates An Ethical Obligation To Study Participants

29% of large clinical trials remain unpublished five years after completion and, of those, 78% have no results publicly available, according to a paper published yesterday.This means that an estimated 250,000 people have been exposed to the risks of trial participation without the societal benefits that accompany the dissemination of their results, worry the authors. Of course, the participants all volunteered for the trials and had informed consent and many were even paid so claiming they were 'exposed to the risks' is emotional verbage designed to guide the public into one conclusion: all trial results should be published.Of course, reality is not so simple. The public is already barraged with an array of media claims about studies that are not even published (Oreos are as addictive as cocaine,anyone?) - adding numerous trials with null results doesn't help. And if the trials were not funded with taxpayer money - most drug trials are not - there is no reason failures of products that will never get to market need to be made available, unlike government-controlled science that should obviously be published because the public paid for it.Yet they argue that non-publication "violates an ethical obligation that investigators have towards study participants" and call for additional safeguards "to ensure timely public dissemination of trial data" because, they argue, randomized clinical trials are not just designed to show a product works but are a critical means of advancin...
Source: PharmaGossip - Category: Pharma Commentators Authors: Source Type: blogs