A Blueprint for Cancer Research in the Next Decade
Tremendous progress has been achieved over the 50 years since the American Society of Clinical Oncology was founded. Investment in cancer research has increased dramatically, spurring major increases in survival and a revolution in our biological understanding of cancer. Many of these advances are highlighted in the Cancer Progress Timeline.
But there is still an urgent need to accelerate the pace of clinical cancer research, the engine that drives progress against the disease. Nearly 500,000 people die from cancer in the United States each year, and the disease is projected to become the nation's leading killer in the years ahead. Worldwide, the burden of cancer is growing quickly.
A New Era of Clinical Research
Cancer science is undergoing 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. Cancer is increasingly defined – and treatments developed – according to molecular characteristics, not only location in the body. At the same time, new technologies – from fields such as nanotechnology, medical imaging and health information technology (HIT) – are leading to entirely new ways to develop therapies.
If the promise of these advances is fully realized, cancer patients will benefit from treatments that are more personalized, more efficient and more effective.
The Challenge: A System Unprepared for the Molecular Era
Our nation's clinical and translational research system is not fully equipped to deliver on the potential brought by recent scientific and technological advances:
Current drug development approaches are not equipped to capitalize on our new knowledge. Researchers have a limited understanding of which molecular pathways are most important to target and a lack of diagnostics to identify patients with these key molecular markers. Financial and regulatory barriers hinder companies' and researchers' ability to collaborate on new approaches.
Clinical trials – involving rigorous studies that test the safety and efficacy of new therapies in people – have not kept pace with personalized cancer medicine. Current trial designs lack the flexibility to provide quick answers about treatments tailored to specific groups of patients who are defined by their molecular characteristics. At the same time, clinical research efforts have been weakened by a labyrinth of regulatory requirements and years of under-funding.
The promise of health information technology is only beginning to be realized. Limited, uncoordinated and inconsistent use of HIT tools to date, including electronic health records and other, more advanced technologies, has inhibited efforts to accelerate research and improve patient care.
A Vision and Recommendations for the Future
In November 2011, ASCO released Accelerating Progress Against Cancer: ASCO's Blueprint for Transforming Clinical and Translational Cancer Research, presenting a vision for the next decade, in which cancer research and patient care become significantly more targeted, efficient and effective. The Blueprint includes real-world recommendations to policymakers and the cancer community in three key areas:
- Establish a new approach to therapeutic development, driven by our more thorough understanding of cancer biology and the advent of new technologies.
- Identify and prioritize the molecular targets that have the greatest promise to extend patients' lives.
- Incentivize collaboration that encourages researchers to pursue high-priority targeted therapies and diagnostics in combination.
- Ensure more aggressive and timely development of biomarkers and diagnostic tests to guide treatment decisions and speed research.
- Design smarter, faster clinical trials to provide evidence for effective treatments targeted to patients most likely to benefit.
- Prioritize trials with the greatest potential benefits for patients, or that address clear unmet needs. Also, shift away from trials that promise only marginal improvements in care.
- Develop common standards for flexible trial designs that allow researchers to demonstrate results with smaller populations, selected based on the molecular characteristics of their disease.
- Revitalize the National Cancer Institute's Clinical Trials Cooperative Group Program (see sidebar), including full implementation of the Institute of Medicine 2010 report, A National Clinical Trials System for the 21st Century.
- Harness advances in health information technology to seamlessly integrate clinical research and patient care.
- Use health information tools, including electronic health records and "rapid learning" systems like ASCO’s CancerLinQ, to enable the experiences of all patients to inform our understanding of the effectiveness and safety of treatments, and to help us focus on the most important research questions.
- Standardize electronic health records, harmonizing data fields and ensuring secure patient and provider access to information at any time.
- 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.
- Ensure that advances protect patient privacy, while enabling information sharing and intellectual property protections to support HIT innovation.