Considerations for Managing and Monitoring Your Immuno-Oncology Clinical Trial
Not every site is capable of performing an immunotherapy/immuno-oncology clinical trial. And not every CRO is capable of selecting and supporting the sites that ARE capable.
Immuno-oncology clinical trials are more popular than ever, with recent advances in technology and approvals marking it as the “future of cancer therapies” in the eyes of many researchers.
The History and Growth of Immuno-Oncology
Immuno-oncology involves the use of checkpoint inhibitors, cellular therapy, cancer vaccines, and other modalities to treat cancer. Starting in the early 2010s, the first wave of immuno-oncology trial approvals began. From 2014 to 2017, new trials within I-O grew nearly 140%, primarily with biomarker and checkpoint inhibitor studies.
From 2019 to 2020, the cancer cell therapy pipeline grew from 472 active agents to 1,483 active agents globally. Chimeric antigen receptor T (CAR-T) cell products had the greatest growth within this time period at approximately 77%.
Immuno-oncology Clinical Trial Site Selection
Not every site is capable of performing immuno-oncology clinical research. Identifying and working with sites that are highly specialized within immuno-therapies is critical to study success. At PharPoint, our detailed feasibility process ensures the sites selected for your studies are able to perform these tasks.
Understanding Study Nuances: Allogeneic vs. Autologous Therapies
If a CRO is selecting sites for an immuno-oncology clinical trial, it’s important that both the CRO team and sites selected have an understanding of the different obstacles encountered when managing and monitoring allogeneic vs. autologous therapies.
Autologous therapies typically have highly complicated logistical challenges to face, and require a CRO that’s up to the challenge and capable of mitigating risk and avoiding delays. As a CRO with I-O experience, PharPoint understands the lead time involved in developing autologous therapies, and has experience managing this at the subject, site, and tissue culturing level.
Allogeneic therapies, on the other hand, typically have a smaller logistical burden for CROs to manage. However, as these therapies have an increased complexity surrounding rejection, an understanding of the adverse events and clinical indicators that come with allogeneic therapies is critical.