6 Reasons Early Phase Oncology Trials Fail

Only 15% of oncology drugs that get started in clinical trials reach phase III studies, and the likelihood of approval (LOA) for any new anticancer drug entering clinical trials is just over 5%.1 This is not only expensive but also frustrating and discouraging for all involved. Furthermore, it creates a deterrent to sites and patients who might be willing to participate if the odds of success were greater.

WHY IS THE SUCCESS RATE SO DISMAL? WHAT CAN YOU DO FROM THE START TO AVOID A FAILED EARLY-PHASE STUDY?

The world of oncology clinical trials is changing. Anticancer therapies hitting the realm of clinical research increasingly include molecularly targeted agents (MTAs) – small molecule inhibitors, monoclonal antibodies, and immunotherapies – which, up until two decades ago, were largely just part of the dream of precision medicine. Unfortunately, these new classes of therapies fail prior to approval at alarmingly high rates, in part due to the fact that the entire history of early-phase oncology trials has evolved around the proper study of a different class of drugs: cytotoxic agents. But there’s clearly more to the story.

New therapies for cancer face an uphill battle. Unlike many studies of drugs for chronic diseases and acute illnesses, cancer drugs must typically demonstrate a substantial impact on progression-free survival in a group of patients who desperately need an effective treatment. Side effects and quality of life, together with surrogate efficacy end points, create a daunting array of data to juggle and factors to consider. This pressure can make it even more challenging to select a contract research organization (CRO) to help bring your drug from preclinical studies to post-approval success.

By proactively working to avoid the common roadblocks in early-phase oncology trials – and bringing in trial planning and administration experts to lay out an optimal strategy for your drug development program – you can give your drug the best possible chance at success.