RPCI Selected by NCI to Take Leadership Role in Clinical Research on New Cancer Treatments

$3 million Lead Academic Participating Site (LAPS) grant to fast-track phase III research

BUFFALO, N.Y. — Roswell Park Cancer Institute (RPCI) was chosen by the National Cancer Institute (NCI) to serve as a Lead Academic Participating Site (LAPS), providing scientific leadership for the development and conduct of clinical trials within the NCI’s new National Clinical Trials Network(NCTN). The NCTN was created to speed the late-phase clinical trials that are necessary to establish new therapeutic agents as cancer treatments for the 1.6 million Americans diagnosed with cancer each year.

As one of 30 LAPS institutions, RPCI will provide scientific leadership in the development and conduct of clinical trials. RPCI receives a five-year, $3.08 million grant for this work and for increased patient-accrual costs.

The previous structure of the NCI’s national clinical trials program, which brought together nine adult Cooperative Groups, was deemed to be inefficient. The new NCTN consolidates the nine groups studying adult cancers into four, and one large group will continue to focus on childhood cancers. In addition, the NCTN aims to achieve four crucial goals suggested in a 2010 report from the Institute of Medicine:

• Speeding the design, launch and conduct of clinical trials
• Optimizing scientific innovations
• Prioritizing research endeavors
• Expanding participation of patients and physicians

In particular, the NCTN aims to streamline the late-phase clinical research necessary to assess and validate new treatments for use in larger numbers of patients. The that end, the NCTN has created:

• A single, common data-management system to be used all clinical studies, easing data sharing and analysis
• One NCI Central Institutional Review Board to cover all studies
• Integrated tumor specimen banks and informatics systems

RPCI’s efforts will be led by four Roswell Park faculty leaders: Ellis Levine, MD, Professor of Oncology in the Department of Medicine; Alex Adjei, MD, PhD, Senior Vice President of Clinical Research and Katherine Anne Gioia Chair in Cancer Medicine; Shashikant Lele, MD, Clinical Chief of Gynecologic Oncology; and Anurag Singh, MD, Professor of Oncology and Director of Clinical Radiation Research within the Department of Radiation Medicine.

“Through RPCI’s participation in the NCTN, the population of Western New York has access to new approaches to cancer care that would not otherwise be available to them,” says Dr. Levine, “potentially improving quality of life for patients and their families.”

Another important benefit of this new national structure will be seen in the ability to conduct clinical research involving rare cancers, studies in which accruing enough patients to yield meaningful results has always been a challenge. Furthermore, as more cancers are molecularly defined and classified into smaller subsets, the new network enables scientists to conduct trials on specific cancers, specific populations or particular methods.