An Independent Board To Oversee Clinical Trial Data Disclosure?

Over the past year, the heated controversy over disclosing clinical trial data has grown more heated. For instance, pharmaceutical industry trade groups have attacked a proposal by the European Medicines Agency and two drugmakers took court action to prevent the EMA from releasing data. The BMJ will no longer publish studies unless anonymized patient-level data is made available (see this). And a UK parliamentary committee criticized the government for failing to push industry harder for data (back story). Meanwhile, an aggressive online campaign called AllTrials is trying to pressure drugmakers to agree to greater disclosure, but so far, there has been little response. Earlier today, Leo Pharma agreed to support the disclosure effort (see this) and Roche made a similar commitment earlier this year (look here). GlaxoSmithKline (GSK), meanwhile, has joined the AllTrials initiative and is proceeding with a program to make data available (more here). But to what extent any of these companies live up to their promises remains to be seen. And so, a group that includes academics and consultants, some of whom are affiliated with the Multi-Regional Clinical Trials Center at Harvard University, have proposed a learned intermediary, or an independent board, to find a way through the disclosure thicket. Their proposal was mentioned in a discussion about the problems and challenges with data disclosure in a piece this week in The New England Journal of...Read more
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs