Stem cell, gene therapy, mAb, TCR enhancers and small molecules, oncolytic viruses--immunotherapy holds great promise for innovative, less-invasive treatments to fight disease, with significant progress already made. 

“The industry has moved from a time where a very broad population of patients received the same treatment, to a scenario where treatments are customized and even individualized for each patient,” says Vice President, Strategic Development Oncology at Synteract Christopher Heckman. But CAR-T cell and cell therapy often pose a number of unique challenges. 

Given the current status of oncology care, finding the right patient has become even more challenging, as sponsors and CROs refine the patient pool using very granular criteria, says Heckman. (Synteract has developed a unique set of tools and experience to find these patients and truly leverage our patient profile paradigm in site and patient selection). 

Another important, yet difficult, aspect of ensuring success in these trials is the ability to anticipate challenges before they happen. Sponsors must consider potential issues around patient screening and selection, logistics, and other aspects of the trial--and be flexible throughout the process. 

Broader use of gene panel analysis and a globalization of data access are positive steps that are already starting to help. These help with screening and selection for indications where a number of mutations have actionable treatment (such as with ovarian and lung cancer). 

Additionally, in basket trials, cancer with differing histologies are pooled and the common element is a singular genetic mutation or protein alteration. The tumors of interest are grouped in baskets for the analysis. 

What issues do drug developers need to anticipate in complex oncology clinical trials? 

Discover three common operational considerations in immunotherapy clinical trials regardless of indication, along with Synteract’s experience in this space.