What is Required for Continued Progress Against Cancer?
Cancer Progress Report 2013: Contents
In this section you will learn:
In addition to providing sustained increases in funding for biomedical research, we can accelerate the pace of progress against cancer by:
advancing regulatory science and policy;
increasing patient participation in clinical trials;
enhancing the cycle of research through the adoption of electronic health records;
improving the quality and consistency of biospecimen resources; and
cultivating a highly skilled diverse research workforce.
This report celebrates the extraordinary contributions to preventing, detecting, diagnosing, and treating cancer made by biomedical research. It also provides a window into a future in which cancer care will be transformed by the discoveries made in laboratories throughout the world. To fulfill the promise of these discoveries we must make cancer research a national priority. This includes investing in the talent, tools, and infrastructure that drive innovation, as well as advancing policies that enable researchers to develop a more comprehensive understanding of cancer and to translate that knowledge for the benefit of patients.
Increased funding for cancer research from the federal government and other sources is clearly required if we are to continue to pursue a comprehensive understanding of the biology of cancer (see
Funding Cancer Research and Biomedical Science Drives Progress). But how we conduct the research matters. Innovative efforts in strategic areas are needed if we are to become more efficient and productive, and here we highlight some of these opportunities.
Advancing Regulatory Science and Policy
As cancer research advances, so must the tools, standards, and techniques for assessing the safety and efficacy of all new products used to prevent, detect, diagnose, and treat cancer. This is particularly important in the realm of precision medicine, where research and development methods are continuously being refined to incorporate advances in basic and clinical research.
For example, it will be necessary to develop improved approaches to identifying, qualifying, and validating biomarkers (see
Figure 18), particularly since their use is becoming increasingly important for developing effective diagnostic tools and therapies and making treatment decisions. Likewise, advances in clinical trial design are needed if we are to test drugs more rapidly and efficiently. This is particularly important for the evaluation of molecularly targeted drugs that attack cancers by honing in directly on the genetic and molecular abnormalities that drive them (see sidebar on
Molecularly Informed Clinical Trials). To advance regulatory science and policy, the FDA must have the resources to recruit and retain highly qualified staff, as well as develop new tools and techniques. They must also have the means to fully engage with the broader scientific community in discussion about areas of scientific progress so that the work of this important agency will benefit from the latest advances in the field. Likewise, these interactions also benefit the broader scientific community by providing it with a better understanding of regulatory policies, facilitating the translation of discoveries into new and improved therapies.
Engaging Patients in Clinical Research
Clinical studies, particularly clinical trials, are a key component of cancer research (see sidebar on
The Virtuous Cycle of Biomedical Research) because they enable researchers to demonstrate that therapies showing promise in the laboratory are safe and effective for use in people. Typically, researchers conduct randomized clinical trials wherein experimental interventions are tested against the current standard of cancer care in patients and, in some cases, healthy volunteers. Although patient participation in these studies is critical, fewer than 5 percent of adult cancer patients participate in a clinical trial (173). An even smaller fraction of patients from specific subgroups, like the elderly, women, racial and ethnic minorities, and people living in rural areas, participate in clinical trials, which leads to a lack of understanding of whether a drug is safe and effective in these populations. Low participation can slow the progress of clinical trials and delay the development of new therapies.
If we are to speed the translation of cancer research discoveries into new treatments, it is essential that all stakeholders work together to overcome the obstacles that discourage people from participating in clinical research studies. These obstacles may include a lack of information about the clinical research process, lack of awareness of studies for which patients are eligible, concerns about adverse side effects, the cost and quality of care, and a mistrust of the research establishment. Logistical challenges such as lack of transportation to and from distant trial sites may also make it difficult for otherwise willing volunteers to participate. To overcome these obstacles it will be important to improve outreach to patients, researchers, health care providers, policymakers, and the general public with the goal of providing accurate information about the clinical research process and the value of public participation in research. These groups must also work together to identify and implement solutions to the barriers that hamper research participation.
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Integrating Research and Patient Care
Cancer research is conducted in many places and in many ways (see sidebar on
The Virtuous Cycle of Biomedical Research), from studying cells in dishes in laboratories to testing new drugs through clinical trials. Regardless of the form that it takes, research involves generating, compiling, and analyzing information. The adoption of electronic health records (EHRs) is making it possible to gather data about what works best and for whom during the routine care of patients in everyday clinical settings. In this way, research and clinical care are increasingly becoming integrated. When fully implemented, a national EHR system will enable researchers to use data gathered in the clinic to answer pressing scientific questions and generate new research hypotheses. It will also help clinicians to deliver higher quality and more rapid care that is consistent with the latest research findings. To make this vision a reality, it is important to continue to promote the development of infrastructure and standards that enable the capture, aggregation, and analysis of information important to patients, clinicians, and researchers alike. Further, policies need to be developed and implemented to protect participant privacy and respect their informed consent regardless of how the information is collected or used.
Improving Biospecimen Repositories
Much of our current understanding of cancer biology comes from studying tumor samples and other “biospecimens” that have been provided by patients. Such specimens will continue to be a critical component of cancer research and biomedical science. Unfortunately, many of the biospecimens available today are not suitable for use in research for a variety of reasons. Chief among these are an absence of standards in the collection, preparation, and/or storage of biospecimens, and an insufficient amount of accompanying clinical data. Studies using poor-quality biospecimens may yield inconclusive or erroneous results. Therefore, improving the quality and consistency of biospecimen resources is a top priority in cancer research. The research community must establish and adopt universal standards for collecting, annotating, cataloguing, and storing biospecimens, and the policies and infrastructure must be developed to enable more researchers to access these samples and the data generated through their use.
Cultivating a Highly Skilled and Diverse Cancer Research Workforce
Continued progress against cancer depends on cultivating a highly skilled and diverse research workforce. Unfortunately, the lack of funding is jeopardizing our ability to attract students to research and driving established investigators out of the field (see
Funding Cancer Research and Biomedical Science Drives Progress). The current research environment poses difficulties for all scientists, but the challenges are particularly acute for young investigators (174).
It is especially difficult to recruit and retain scientists from historically underrepresented groups. A report by the NIH shows that while individuals identifying as Latino or Hispanic comprised 16.3 percent of the U.S. population in 2010, they accounted for a mere 3.5 percent of NIH principal investigators (175). Likewise, African-Americans, who made up 12.6 percent of the U.S. population in 2010, comprised only 1.1 percent of NIH-funded principal investigators. Although the reasons for these disparities are complex and multifaceted, one thing is clear: Innovation is driven by diversity of perspectives. By harnessing the scientific potential of people from all backgrounds and communities, we can foster a wider range of scientific ideas and accelerate the pace of progress against cancer.
In addition to providing the resources to recruit and retain talent to science, we must equip our workforce with the knowledge and skills to be able to conduct 21st century cancer research. This means continuing to provide world-class training in basic, translational, and clinical research; ensuring trainees have access to cutting-edge tools and techniques; ensuring all researchers can participate in the latest scientific meetings and conferences; and cultivating the skills they will need to succeed in the interdisciplinary research teams that have become commonplace. Researchers across the entire biomedical research enterprise must also have access to professional development resources and support, including access to effective mentors, training in laboratory management, opportunities to hone their grant and manuscript writing skills, and exposure to the breadth of career opportunities in the relevant sciences.
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Progress Report 2013 Contents