By Gaurav Sharma, M.PHARM, PMP, C.SCI, FIBMS, MICR and Senior Vice President, Project Management, Oncology
Clinical development for oncology trials isn’t what it used to be. Just between 2013 and 2018, the number of oncology drugs in late-stage development grew by 63%.1 Newly launched drugs reached a record high in 2018, despite the overall success rate of fewer than 10% of all products entering development.
Although the landscape is competitive, companies that can position themselves strategically during preclinical explorations and throughout the development process can bolster their chances of achieving approval and market success. To do so, they must understand key elements of the “new” oncology research landscape:
- Diverse competition
- Increasingly complex trial design
- Targeted recruitment considerations
- Operational and regulatory requirements