Medical Innovation

While 21^st-century scientific breakthroughs hold the potential for fundamental improvements in health, including much more personalized and prevention-oriented medicine, the process of turning these scientific insights into safe and effective treatments is long, costly, and uncertain. Between 1990 and 2005, 920 cancer compounds underwent clinical trials, yet only 32 were approved. The average development and approval timeline for those therapies was 9.1 years.

The problems of inefficient and uncertain development are not new problems, but they are more urgent in an era that should be defined by clinically meaningful advances in genomics, proteomics, and the promise of personalized treatments. With more effective ways to predict and demonstrate the safety and effectiveness of such targeted therapies, and with much greater capabilities to integrate and interpret complex data, greater productivity in the development process should be achievable.

Bringing Cancer Therapies into the 21^st Century
The Engelberg Center is to address the productivity challenge in cancer clinical research by working with stakeholders in academia, professional societies, the National Cancer Institute, FDA, product developers and the patient advocacy community. The goal is to identify specific, practical changes to the processes of research, product development, and regulatory approval.

Specific outcomes from this effort will include a decision tree establishing data collection standards for primary and secondary indications for new cancer therapies; an evidence-based and time-saving methodology for validating cancer progression endpoints in clinical trials; and a process for more efficient development and regulatory approval of biomarkers and diagnostic tests to guide cancer therapy.

Activities and Events
In September 2008, the Engelberg Center hosted the Conference on Clinical Cancer Research, with support from Friends of Cancer Research, the American Society of Clinical Oncology and the American Association for Cancer Research. Featuring keynote presentations by NCI Director Dr. John Niederhuber and FDA Commissioner Dr. Andrew von Eschenbach, the meeting was attended by over 150 thought leaders from throughout the cancer community. Four expert panels laid out issues and recommendations for specific and practical next steps in the area of data submission standards, clinical trial endpoints, development of cancer diagnostics, and a vision for the future of FDA. Each panel’s recommendations were summarized in an issue brief available at the conference web site, and multiple follow-on publications are planned. Following the conference, the Center has continued to facilitate and support the development and refinement of these recommendations.

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