The report comes 40 years after President Richard Nixon signed the National Cancer Act in December 1971. That landmark legislation led to major new U.S. investments in cancer research which spurred significant increases in survival and a revolution in our biological understanding of cancer. ASCO’s report is intended to guide researchers, cancer advocates and policymakers as they seek to build on that progress and address a projected increase in the nation’s cancer burden over the coming years.
“Advances in cancer prevention, detection and treatment have already extended the lives of millions of adults and children living with cancer – but the critical question is, ‘Where do we go from here?’” said ASCO President Michael P. Link, MD. “With the cancer burden growing rapidly around the globe, millions of future patients are depending on the answer. This report aims to set us on a path to deliver the new therapies that patients urgently need.”
The report was developed under the guidance of three ASCO members who served as executive editors: Mark G. Kris, MD, of Memorial Sloan-Kettering Cancer Center; Neal J. Meropol, MD, of University Hospitals Case Medical Center & Case Western Reserve University; and Eric P. Winer, MD, of the Dana-Farber Cancer Institute.
A research system unprepared for the molecular era
ASCO’s report highlights that cancer science is undergoing a period of revolutionary change. Thanks to a rapidly growing understanding of the biology of cancer, treatments can increasingly be targeted to the molecular “on-off” switches that drive uncontrolled growth of cancer cells. At the same time, new technologies – from fields such as computational chemistry, medical imaging, nanotechnology, health information technology and genetic engineering – are leading to entirely new ways to develop therapies.
However, the report argues that the U.S. cancer clinical research system is not fully equipped to deliver on the promise of these scientific and technological advances:
- Drug development is hampered by researchers’ limited understanding of which molecular pathways (consisting of genes and proteins, often with mutations) are most important to target; by a lack of diagnostics to identify patients who are likely to benefit; and by financial and regulatory barriers that hinder companies’ and researchers’ ability to collaborate on new approaches.
- Clinical trials have not kept pace with personalized cancer medicine. Trial designs lack the flexibility to provide quick answers about treatments tailored to specific, molecularly-defined groups of patients. At the same time, they are weakened by a labyrinth of regulatory requirements and years of under-funding.
- The promise of health information technology (HIT) is only beginning to be realized, because of limited, uncoordinated and inconsistent use of electronic health records (EHRs) and other HIT tools in research and patient care.
ASCO’s vision and recommendations for the future
ASCO’s Blueprint presents a vision for the next decade,in which cancer research and patient care become significantly more targeted, more efficient and more effective. To help achieve this vision, the report provides real-world recommendations to policymakers and the cancer community, including ASCO, in three key areas:
1. Establish a new approach to therapeutic development, driven by our more thorough understanding of cancer biology and the advent of new technologies.
o Identify and prioritize the molecular targets that have the greatest promise to improve survival
o Incentivize collaboration to encourage industry and researchers to pursue high-priority targeted therapies and diagnostics in combination
o Ensure more aggressive and timely development of biomarkers and diagnostic tests to guide treatment decisions and speed research
2. Design smarter, faster clinical trials to provide evidence for effective treatments targeted to patients most likely to benefit, sooner:
o Prioritize trials with the greatest potential benefits for patients, or that address clear unmet needs; shift away from trials that promise only marginal improvements in care
o Develop shared standards for flexible trial designs that allow researchers to demonstrate results with smaller populations defined by specific molecular characteristics
o Select trial participants primarily based on molecular characteristics, to ensure that only those who are most likely to benefit are included, and that patients aren’t excluded from trials because of health conditions that aren’t relevant
o Revitalize the National Cancer Institute's Clinical Trials Cooperative Group Program, which has been instrumental in much of the progress achieved against cancer to date. ASCO supports the continued efforts by the NCI, the Groups, and other stakeholders to fully implement recommendations issued by the Institute of Medicine in 2010 to revitalize this essential component of the nation’s cancer research system
3. Harness advances in health information technology to seamlessly integrate clinical research and patient care:
o Use HIT tools, including EHRs and “rapid learning” systems, to allow researchers to draw upon the wealth of real-world patient information that is now locked away in file cabinets and unconnected computer systems
o Standardize EHRs by defining functional requirements, harmonizing data fields and ensuring secure patient and provider access to information at any time
o Develop industry standards for working with, storing and capturing information from biospecimens (tissue and blood samples), which are essential to identifying and evaluating new therapeutic targets
o Ensure that advances in HIT protect patients and researchers by examining the need for revised standards for patient privacy, information sharing and intellectual property protections to support HIT innovation
Over the next three years, ASCO plans to work with partners throughout the research community to develop more detailed plans of action for each of the three areas covered in this report.
To read the Blueprint, please click here.