Clinical Data Transparency Is Big Challenge For Smaller Sponsors :: Pink Sheet

"Biopharma companies with the most effective and robust clinical trial disclosure programs often have one thing in common: a leadership that recognizes the importance of transparency beyond mere regulatory compliance.

These companies –  primarily some of the largest pharmaceutical firms such as GlaxoSmithKline plc – have a commitment at the executive level to, for example, publish their disclosure policies, making generous commitments to protocol registration, results disclosure, plain language summaries, and the sharing of a broad range of clinical documents. They invest as well in both tools and company policies to meet these commitments.

In contrast, smaller companies typically delay in investing in the focused systems needed for even the modest goal of regulatory compliance, let alone providing for a strategic view into disclosure activities. For example, they often are making do with manual, spreadsheet-type approaches rather than a centralized review and monitoring system. But repercussions of having less effective programs can go well beyond just regulatory penalties. (See sidebar.) ..."