Oncology trials have always presented special challenges given the trial designs and often complex inclusion exclusion criteria. As biotechs are developing more specialized novel therapies for oncology patients, whether a targeted therapy or an immuno-oncology therapy, it is common that the development program requires a highly specific population to meet the regulatory goals. This may be due to an attempt to use the Accelerated Approval pathway or to achieve Breakthrough Designation for unmet medical needs, with even greater scrutiny of the ongoing program.
This discussion addresses the following:
- Trial design challenges for specific oncology populations - Get the protocol right
- Country and Site Selection considerations for the recruitment of challenging oncology studies
- Facilitating patient recruitment across the study
- Supporting the sites
- Supporting the patients and caregivers