Tagged: Risk-Based Monitoring

Biopharma’s R&D Productivity Problem Resurfaces as We Enter 2014

While FDA approvals of truly new drugs and biologics soared to 39 in 2012, the story as we enter 2014 shows a striking reversion to lower productivity levels that have long plagued the industry. The number of FDA approvals dropped to 27 in 2013. Big Pharma can take credit for only 14 of the approved… Read more »

The FDA’s Final Risk-Based Monitoring Guidance and Beyond

The FDA has issued the final version of its risk-based monitoring guidance. In my view, this represents a milestone in industry and regulatory understanding of the extent to which electronic systems can increase the efficiency of clinical trials while maintaining data quality and patient safety. The guidance does not dismiss the value of site visits,… Read more »

Why Incrementalism Won’t Fix Clinical Development

A recent study by the UK’s Office of Health Economics shows no let-up in pharma’s efficiency crisis. OHE’s study sets the cost of R&D for a new medicine at $1.9 B. Discussions I’ve had this week with senior staff at several large pharma companies were a reminder of why efficiency remains a major issue for… Read more »

Adaptive (Risk-Based) Monitoring

A group of senior executives from a company we work with today mentioned hearing pitches for adaptive monitoring from some of the big CROs they work with.  “Nothing there, but I did get the sense that these guys want to sell us a big project,” was the consensus.  We hear similar comments frequently, often during… Read more »