September 2013 – The CenterWatch Monthly : PDF
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