Tagged: Tufts

Clinical Research Now: One Foot in the 21st Century, the Other in Ancient Greece

We do 21st century biology in our laboratories and then do clinical trials that Hippocrates would have been quite comfortable with.  – Roger Perlmutter, executive vice president of Merck and president of Merck Research Laboratories, in a panel discussion at the Forbes Healthcare Summit in October. Perlmutter’s characterization of current clinical trials rings true.  Much… Read more »

Are Your Clinical Operations Adaptive-Ready?

The Adoption and Impact of Adaptive Trial Designs, a new report from the Tufts Center for the Study of Drug Development, confirms something that I’ve been saying for years – you can’t use adaptive designs without highly efficient operations: Operating concerns – specifically delays and disruptions in trial execution, patient participation and distribution of clinical… Read more »

Enrollment as a Learning Problem

The Tufts Center for the Study of Drug Development’s January/February 2013 Impact Report has stirred comment and criticism. Paul Ivsin of Placebo Control dismisses the significance of learning that 48% of sites miss their enrollment targets; Ed Silverman at Pharmalot does the reverse.  The biggest takeaway from my perspective is this: “Study timelines typically extended… Read more »

Surviving the Big Squeeze in Biopharma Development

The biopharma industry finds itself in a squeeze that rivals the drama of the garbage-compactor scene in Star Wars. On one side, operational inefficiency keeps closing in. Outlook 2013 from the Tufts Center for the Study of Drug Development reminds us that new business models haven’t solved the industry’s efficiency problems. Another recent Tufts CSDD… Read more »