Traditional Phase II Oncology Trials Just Don't Cut It

Posted on Dec 30, 2009

A recent article (originally appearing in Oncology NEWS International Vol. 18 No. 12) discusses traditional Phase II trials for oncology and whether or not they should be phased out. The author writes that “shortages in funding, manpower, and willing patients have created the proverbial perfect storm in the current clinical trial system” – which puts even more pressure on drug developers to reevaluate traditional Phase II studies.

The article provides two opposing viewpoints: Dr. Richard S. Kaplan, an associate director of the National Cancer Research Network in the UK, argues that Phase II studies have not reliably met the challenges in oncology trials, while Dr. Alberto Sobrero, director of medical oncology at Ospedale San Martino in Genoa, Italy, points out that traditional Phase II trials have led to the development of useful drugs, and are worth keeping as long as certain caveats are taken into consideration.

Regardless of which side you are on, it is clear that steps need to be taken to improve the way Phase II oncology trials are designed and run. Sponsors just can’t afford traditional trials designed in the formative years of oncology, based on needs and assumptions that are no longer relevant.

Trial designs must be evaluated based on current best practices that take into account all available processes and technologies. It’s increasingly important for sponsors and CROs to take a hard look at adaptive design methodologies, randomization, response rate endpoints, trial size, and other factors to help eliminate waste and cut timelines while ensuring the highest level of patient safety.