Funding cuts continue to be a threat

ASCO marked significant progress toward modernizing clinical cancer research as outlined during the Opening Press Briefing of the Society’s 49th Annual Meeting this past June, in Chicago, but warned that advances against cancer could stagnate as a result of recent cuts to U.S. biomedical research funding.

At ASCO’s 2013 Annual Meeting, the Society released “Progress Report: Implementation of ASCO’s Blueprint for Transforming Clinical and Translational Cancer Research,” which looks at the gains made toward achieving goals set forth in its landmark 2011 report, “Blueprint for Transforming Clinical and Translational Cancer Research.” The Progress Report and Blueprint are available online.

“Our federally funded clinical trials system has achieved remarkable advances that have improved survival and quality of life for millions of people with cancer, but this progress is occurring under the cloud of federal budget slashing,” said ASCO Immediate Past President Sandra M. Swain, MD, FACP. “Draconian cuts to biomedical research will slow our progress at the moment of greatest scientific potential and increasing worldwide need.”

Funding for the U.S. National Institutes of Health (NIH) is at its lowest level since 2001 (adjusted for inflation), a drastic reduction in the nation’s historical commitment to biomedical research. ASCO called on Congress to maintain a strong commitment to federally funded research with a recommended NIH budget of $32 billion for fiscal year 2014.

Achieving the Blueprint’s vision
In November 2011, ASCO’s Blueprint laid out a roadmap for the clinical research system to capitalize on the new understanding of cancer biology. Since issuing the Blueprint, ASCO has worked with partners to drive its recommendations forward. Other major stakeholders, including the National Cancer Institute (NCI) and U.S. Food and Drug Administration (FDA) have launched initiatives that will contribute to achieving the Blueprint’s vision.

Examples include:

• ASCO’s efforts to develop recommendations on clinically meaningful outcomes for clinical trials to help ensure that clinical trials for new cancer therapies are designed to achieve meaningful improvements in patient survival and quality of life
• FDA’s “Breakthrough Therapy”initiative to prioritize and streamline development of highly promising new therapies
• NCI’s actions to strengthen the Cooperative Group Program, which will revitalize federally funded clinical research
• ASCO’s completed CancerLinQ™ prototype, the first step toward fulfilling the Society’s commitment to develop a rapid learning system for cancer care

In addition, ASCO has developed an icon to denote when federally funded research was used for a project; this icon will be used on press materials and other publications and at Society meetings to draw attention to the importance of public research funding. ASCO is sharing the icon with other organizations to encourage its use.

Experts emphasize initiatives,need for funding
At the press briefing, Richard Pazdur, MD, Director of the FDA Office of Hematology and Oncology Drug Products, said that the agency’s new “Breakthrough Therapy” initiative allows for closer interaction with drug sponsors earlier in the development process. Under a law passed in 2012, the agency can designate some experimental drugs as “breakthroughs” based on preliminary evidence that the drug may provide a substantial improvement in treating serious diseases. One goal of the program is to speed FDA review times for drugapplications; another is to address manufacturing issues that may hold up drug availability.

Monica M. Bertagnolli, MD, Group Chair of the Alliance for Clinical Trials in Oncology (an NCI-supported clinical trials cooperative group) also spoke at the press briefing and emphasized the importance of publicly funded cancer clinical research, which only receives approximately $243 million per year from NCI.

“Our only goal is to maximize benefit to patients and society,” Dr. Bertagnolli said. Publicly funded groups compare effective and promising regimens with each other, optimize multimodality treatments, develop therapies forrare cancers, and conduct researchon prevention strategies and cancer survivorship.

“Even before the funding cuts brought on by sequestration, funding deficits have significantly limited our ability to conduct potentially transformative clinical research,” Dr. Bertagnolli said. Data for Cancer and Leukemia Group B demonstrate that as the group’s NCI funding fell by 12% from 2003 to 2011, so did publications and the number of new clinical trials and patients enrolled.

The cooperative groups have undergone a much-needed restructuringand are poised to make best use of public funds, Dr. Bertagnolli said. Thespeed of trial activation has dramatically increased, and NCI has committed to increase payments to study sites. Sustained funding will be critical tothe success of the new National Clinical Trials Network, she added.