Some of the world’s largest pharmaceutical companies have improved the transparency of their clinical trial data disclosures, according to new analysis from Bioethics International, yet many studies for approved drugs still go unreported. Bioethics International’s second Good Pharma Scorecard, published in the online medical journal BMJ Open, found that companies have made “meaningful progress” on several key metrics since the first scorecard was released in 2015. Companies are doing a better job in complying with legal requirements for reporting clinical trial results, according to the analysis, and making results publicly available for trials conducted in patients.
FDA proposes collaborative approach for pediatric rare disease research
For more efficient development of treatments for pediatric rare diseases, sponsors can implement controlled, multi-arm, multi-company clinical trials, according to a new draft guidance that the FDA says could help eliminate the need for certain studies. The proposed, double-blind design would minimize the number of patients receiving a placebo, using a single control group for multiple investigational drugs. In addition, a single treatment arm could be stopped early following clinical decline. While the guidance itself focuses on treatments for Gaucher disease, a rare, inherited metabolic disorder, the FDA hopes the plan can be extended as a model for other areas of pediatric drug development, according to CDER Director Janet Woodcock.
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