Experts meet to challenge approaches of testing and developing cancer treatments

Workshop hosted by Georgetown University Center for Drug Development Sciences

Despite advances in recent decades, cancer remains a leading killer around the world, and effective therapies still elude many patients who need them. Comparing drug development practices in other therapeutic areas, national leaders in oncology and drug development and regulatory scientists will debate and identify improvements to intensify and accelerate clinical evaluation of novel oncology therapies.

“Although cancer shares characteristics of other life-threatening chronic diseases, it is often called a ‘different’ disease and thereby can follow different clinical trial protocols,” said Dr. Carl Peck, workshop co-chairman and director of Georgetown’s Center for Drug Development Science (CDDS). “Different or not, proportionate to the large number of new oncology drugs being tested, fewer cancer drugs are being approved than in similar diseases – this calls for critical assessment of cancer development methods in comparison with other approaches.”

At the workshop, case studies from other therapeutic areas such as asthma and arthritis will be presented to show successful models of drug development. Workshop participants will participate in breakout groups to discuss employment of scientific clinical trial designs and better use of biomarkers and predictive diagnostic techniques in developing oncology agents. Other breakout groups will consider predictive diagnostic techniques, combination oncology therapies, and oncology trial infrastructure issues. The goal of the workshop is to develop concrete action items for change.

Workshop co-chairman Mark Ratain, MD of the University of Chicago said “We owe it to our patients to improve the system, with strong consideration of departure from traditions. Other specialties have long utilized adequately sized phase 2 trials that are randomized to compare different doses or standard treatments. Furthermore, in the post-genome era, we should routinely evaluate genetic markers to identify which patients are most likely to benefit.”

Deborah Collyar, President of Patient Advocates in Research, a national patient advocacy network, emphasized that “it’s time to stop treating people with ‘one maximum tolerated dose for all’ and start replacing it with targeted, individualized doses that benefit each cancer patient – it is time to do whatever it takes to redesign the system for targeted therapy.”

“We know there is no quick fix to improving testing of new drugs for the complex diseases comprising all cancers,” Peck and Ratain agreed. “That said, the scientific community has an obligation to be self-critical and be willing to adjust current practices if they are not working. Our goal today is to kick-start the debate on how to radically improve future oncology drug development.”

The CDDS has recently sponsored similar workshops that challenge traditional approaches in drug development that are perceived to be slow, inefficient, and in need of scientific and process improvements. Workshops held last year debated and reported ways for confirmatory evidence to support a single clinical trial as a basis for drug approval and use of advanced modeling and simulation techniques in drug development approval. To underscore the Center’s championship of better dose finding in drug development, CDDS recently published a study that showed more than 20% of the drugs approved in the United States are released a dosage level that is later discovered to be too high, resulting in the subsequent lowering of the recommended dosage level.

The mission of Georgetown’s Center For Drug Development Science is to establish clinical drug development science as a rigorous academic discipline for advancing new scientific methodologies, to contribute to the education of scientists engaged in clinical evaluation of drugs, and to provide solutions to real-world drug development problems. For more information, visit http://cdds.georgetown.edu.