Product Details

Sponsors look to collaborate on comparator drugs

New research suggests comparator drugs and co-therapies used in clinical studies comprise a larger proportion of clinical research budgets than previously thought—and contribute significantly to the rising cost of drug development.

Early adopters implement risk-based monitoring pilot programs

The drug development industry has begun to move forward in supporting risk-based monitoring models, yet sponsors and CROs remain uncertain about the best ways to implement this new approach and how regulatory agencies will respond. As a result, companies have launched experiments that, in the short term, will mean uncertainty and change across the clinical research enterprise.

Also in this issue:

• Preventing dual enrollment in early/late phase trials
• Being patient-centric involves focus, convenience
• Regulatory Update
• Month in Review
• FDA Actions
• Study Lead Opportunities
• New Drugs in the Pipeline