Implementing a National Cancer Clinical Trials System for the 21st Century Workshop Summary (2011) / Chapter Skim
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Implementing a National Cancer Clinical Trials System for the 21st Century
Implementing a National Cancer Clinical Trials System for the 21st Century
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conduct a consensus study of cancer clinical trials and the Cooperative Group Program and develop 1
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interactions between industry, the Food and Drug Administration, and the publicly funded cancer clinical trials system; and (4) the role of clinical 1 The Executive Summary from the Institute of Medicine consensus report appears in Appendix B of this workshop summary.
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Incorporate innovative science and trial design into cancer clinical trials 5. Support and use biorepositories 6.
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NCI Perspective and Current Activities Overview of the NCI Response Dr. James Doroshow, director of NCI's Division of Cancer Treatment and Diagnosis, opened the session with an account of that agency's multifaceted efforts to address the IOM consensus report.
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2 over the course of the next year that will call for a simultaneous external peer review of all parties, so as to "look at organizations one against another and try to facilitate the allocation of the resources that we have in the most appropriate way." The timeline for that initiative is shown in Box 2. The cancer clinical trials network is ripe for transformational, systemic change for the following reasons, Dr.
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organizational management a priority timelines for concept evaluation, protocol development, and trial activation Working with Groups on a single, harmonized approach to clinical trial management, including protocol authoring, case report forms, and standardized data collection and management
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should Administration (FDA) for early review of approved Cooperative lead a trans-agency effort to streamline Group Phase III treatment trials, allowing for 21-day review of a and harmonize government oversight concept if it has been identified as a licensing trial and regulation of cancer clinical trials Developed coordinated protocol development and review processes with Groups for Phase III trials developed under FDA Special Protocol Assessment (SPA)
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clauses for company and academic collaborations; accelerated clinical trials negotiations Assessing feasibility of developing standardized Material Transfer Agreements (MTAs) that cover intellectual property (IP)
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grants by the high-quality, standardized central National Institutes of Health (NIH) for National Specimen Banks biorepositories when samples are to include common operating procedures for samples collected from collected from patients in the course patients enrolled in Cooperative Group and other NCI-supported of Group trials and should implement trials and to reflect consolidation of the Group system new funding mechanisms and policies to support the management and use Working with Groups to develop a common review process and of those resources for retrospective procedures for requests for biospecimens banked from clinical trials correlative science Identified the need to develop shared information technology (IT)
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to develop the Cancer Trials Reporting Program database to provide accrual information related to all NCI-supported clinical trials
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recommendations; developing an extramural group to provide strategic input for clinical trials network, under CTAC guidance Revamped prioritization process for large Phase II and Phase III treatment and control trials by creating disease- and modality-specific steering committees to ensure that the most important trials are given highest priority. Note that facilitate trial implementation, rather than to direct the primary review identify critical clinical trials issues for future studies 11 continued
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TABLE 1 Continued 12 Goal Recommendation NCI Response as of March 2011 3: Improve prioritization, 9: NCI, Cooperative Groups, and Modernizing the clinical trials IT infrastructure by procuring a selection, support, and physicians should take steps to clinical trials data management system that can be used across the completion of cancer clinical increase the speed, volume, and NCI-supported Cooperative Group System trials diversity of patient accrual and to ensure high-quality performance at all Enhancing trial participant diversity through support for Minority sites participating in Group trials Based Community Clinical Oncology Programs, Patient Navigator Research Program, and other NCI programs Working with patient advocates in concept development and accrual planning, along with Cooperative Groups, disease steering committees, and Patient Advocate Steering Committee 10: NCI should allocate a larger NCI developed targeted initiatives that have increased portion of its research portfolio to reimbursement to sites from $2,000 to $5,000 per enrolled patient the Clinical Trials Cooperative Group for large Phase II studies; additional funding provided for select Program to ensure that the Program Phase III trials based on complexity, as well as for critical biomarker, has sufficient resources to achieve its imaging, and quality-of-life studies unique mission Without an increase in resources, changes in the funding model must be considered in the context of the number of new trials, the total accrual that can be sustained, and the need for supporting correlative science. The need to focus on high-accruing organizations (half of sites accrue approximately 80 percent of patients)
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work groups to assist in the development of approaches to reimbursement for genetic tests used to choose targeted therapy and for the use of helical computed tomography (CT) for lung cancer screening NOTE: ACOSOG, American College of Surgeons Oncology Group; ACRIN, American College of Radiology Imaging Network; CALGB, Cancer and Leukemia Group B; ECOG, Eastern Cooperative Oncology Group; NCCTG, North Central Cancer Treatment Group; NSABP, National Surgical Adjuvant Breast and Bowel Project; RTOG, Radiation Therapy Oncology Group.
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14 IMPLEMENTING A NATIONAL CANCER CLINICAL TRIALS SYSTEM BOX 2 Timeline for Implementing a New Funding Opportunity Announcement for the Cooperative Group Program December 2010–July 2011 Gather information/input from stakeholders and community for new FOA and Guidelines; develop Concept August 2011 NCI Divisional/Clinical and Translational Research Operations Committee Concept Review September 2011 NCI Scientific Program Leadership Concept Review November 2011 Board of Scientific Advisors Concept Review November 2011–March 2012 NCI Division of Extramural Activities Review of FOA and Guidelines Guidelines July 2012 New FOA Released/Published November 2012 Receipt of Competing Applications for new FOA February 2013 Review of Competing Applications by NCI Division of Extramural Activities May 2013 National Cancer Advisory Board Review After October 2013 Rollout of Awards in Fiscal Year 2014 SOURCE: See http://transformingtrials.cancer.gov/files/NCI-Presentation to-Cooperative-Group-Chairs.pdf.
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This structure would have the advantage of being fully integrated, free of operational overlap, and potentially easier to harmonize with respect to biomarker studies and IT, he said; however, he added, NCI ultimately favored a smaller network of Groups, as suggested in the IOM consensus report -- and specifically, as previously noted, a network comprised of four adult Groups and a single pediatric Group. Compared to a single national Group, the small network of Groups provides for greater competition among ideas, makes data management more feasible and less costly, and better facilitates involvement by a broad range of investigators, volunteers, and philanthropic organizations, Dr.
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Therefore, NCI is actively engaged in revising its funding model for cancer clinical trials, Dr. Doroshow reported.
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Grants.5 Another important feature of this model is the existence of an oversight body to guide NCI's management of the clinical trials system, which he characterized as "something that we have woefully lacked." The remainder of Dr. Doroshow's presentation focused on measures NCI has taken in recent years as they relate to specific goals and recommendations of the IOM consensus report, as summarized in Table 1.
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. "Developing a national clinical trials network is an ongoing process," Dr.
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"Under the CCOP Research Base, the scope of the research has grown over the last 20 years," she said; highlights of this expansion included the launch of large, significant, cancer prevention trials and the accumulation of a growing portfolio of cancer control studies focused on methods for early detection and improvements in quality of life, continuing care, and palliative care. She emphasized that cancer prevention and quality-of-life trials require different strategies and produce different types of data than cancer treatment trials and that these differences need to be addressed in attempts to harmonize and standardize data collection and management in cancer clinical trials, as recommended in the IOM consensus report.
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. However, she added, these circumstances also make it more difficult to involve investigators that are not routinely part of the treatment clinical trials program.
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Minasian observed that the Minority-Based CCOP program has been instrumental in accruing minority patients onto cancer clinical trials. The Minority-Based CCOPs account for about a third of the minority accrual onto NCI clinical trials, and about 60 percent of patients accrued through Minority-Based CCOP programs are members of a minority group, she reported.
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. Together, these results suggest the need for improved and enhanced outreach to physicians, so that they engage and accrue more patients to cancer clinical trials, she concluded.
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Buckner noted the collection of tumor and normal tissue samples from hundreds of thousands of cancer patients and those at risk for cancer; these biospecimens are linked to clinical outcomes and treatment protocols, as well as to follow-up data and laboratory observations. Examples of the latter include such high-impact translational research as the prospective clinical trial (TAILORx9)
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As shown in Table 2, nearly half of the funds necessary to conduct such trials have been provided from volunteer hours and from sources apart from NCI. Several recent operational accomplishments by the Cooperative Groups echo the IOM consensus report recommendations, Dr.
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"Academic and community investigators should be rewarded in their grant awards for participating in collaborative research," he said; therefore, grant guidelines and terms of awards should have specific language outlining the rewards for contributing to collaborative science. Coordinated review and support of translational science must occur in order to better integrate the aims of clinical trials and correlative science, Dr.
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Robert Gray of the Dana-Farber Cancer Institute, who leads the Eastern Cooperative Oncology Group Statistical Center, considered the role of statistical centers in a changing Cooperative Group System and their contribution toward meeting goals and recommendations stated in the IOM consensus report. In approaching these challenges, Group statisticians adhered to two basic principles, he said: (1)
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Dr. Gray identified several areas in which the statistical centers have addressed the IOM consensus report goals and recommendations.
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A remote data entry system, originally developed by the legacy Pediatric Oncology Group, was adapted in order to handle the larger volume of studies undertaken by COG. "What transpired as a result of the consolidation was the world's largest childhood cancer research organization, which still encompasses more than 200 pediatric cancer programs in North America, Australia and New Zealand, Switzerland, and the Netherlands," Dr.
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translational science. Organizational and administrative advances included establishment of the NCI Pediatric Central IRB, which has in turn reduced time lines for opening studies; participation in an international collaboration for osteosarcoma; development of an interoperable infrastructure for clinical research between COG and the Pediatric Blood and Marrow Transplant Consortium and the Bone Marrow Transplant Clinical Trials Network of the National Heart, Lung, and Blood Institute (NHLBI)
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Richard Schilsky of the University of Chicago opened the discussion by soliciting brief statements from panel participants regarding their organizations' specific plans to address the IOM consensus report recommendations.
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Sharon Murphy, IOM scholar-in-residence, noted that the IOM consensus report did not recommend a specific number of consolidated Cooperative Groups, and wondered why five, not four, adult groups might not be possible. "I think what we have seen is a rather hasty rush to the altar and some arranged marriages, and this was not what the IOM suggested," she observed.
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Monica Bertagnolli, of CALGB, reiterated the message in the IOM consensus report that these "siloed" institutions need to work together. That NCI has begun to mandate collaboration through peer review is healthy and beneficial to the overall scientific agenda, she said.
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In the meantime, Drs. Buckner and Bertagnolli emphasized, significant collaboration is already under way, as evidenced by numerous joint grants involving combinations of Cooperative Groups, Cancer Centers, and SPOREs.
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Further discussion of such partnerships occurred in the Panel III discussion on interactions between industry, the FDA, and the publicly funded cancer clinical trials system (see "Partnership Between Industry and the Cooperative Groups")
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information and content and trials and translational research to interrogate as the beginning of the hypothesis generation." The scientific development process should reside in the Group committees, in conjunction with Cancer Centers, SPOREs, and other colleagues, he insisted; steering committees should review, rather than generate, trials. Since Cooperative Groups, SPOREs, and Cancer Centers compete for the same pot of money, steering committees should be established to review the entire cancer research portfolio, not just the Cooperative Groups, Dr.
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Bertagnolli replied. "We cannot forget that our work will greatly suffer if we stifle innovation." PANEL II: PAYORS Because the IOM consensus report included recommendations directed toward health care insurers and others who set health care payment policies, the second session of the workshop focused on the relationship between clinical health care professionals and the payors who cover all or part of the costs of patient care within cancer clinical trials.
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He said that traditionally, the company always excluded things 18 The National Comprehensive Cancer Network®, a not-for-profit alliance of 21 of the world's leading Cancer Centers, develops information for stakeholders in the health care delivery system. NCCN serves as an arbiter of cancer care by creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision makers.
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He added that most cancer clinical trials involve combinations of multiple drugs and dosages, and Aetna pays for any and all such treatments within the guidelines of its clinical policy bulletins or within its coverage guidelines. This policy encourages patients to enter clinical trials, typically Phase III trials, for treatments otherwise considered to be experimental.
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About 80 percent of the clinical trials Kaiser Permanente performs are Phase III, and the remainder are Phase II, Dr. Levine reported.
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20 for a Phase I trial, he added. Demonstrating Utility to Payors In addition to supporting the costs of conducting cancer clinical trials, payors ultimately must compensate companies that develop cancer treatments, Dr.
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Biomarkers' "adolescence" makes them ripe for study, he said, and he advocated integrating them into future cancer clinical trials. "There is enough there to say that we think there is some promise in this kid," Dr.
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. Analysis of Cancer Clinical Trials Coverage Dr.
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all commercial health insurance plans offering group or individual coverage, health plans offered through the Federal Employee Health Benefits Program, employer-sponsored plans that self-insure and operate under the Employee Retirement Income Security Act (ERISA) , and state self-insured plans to pay for the routine patient care costs associated with participation in high-quality clinical trials (Phases I to IV)
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Adapted and reprinted by permission from the American Association for Cancer Research: Klamerus et al., The Impact of Insurance on Access to Cancer Clinical Trials at a Comprehensive Cancer Center, CCR Focus, 2010, 16(24) , page 5999.
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SOURCE: Klamerus et al., 2010. Adapted and reprinted by permission from the American Association for Cancer Research: Klamerus et al., The Impact of Insurance on Access to Cancer Clinical Trials at a Comprehensive Cancer Center, CCR Focus, 2010, 16(24)
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"In a Phase I clinical trial, almost by definition, the drug is not approved, and we are not charging for it and we are not charging research costs associated with studying that drug's pharmacokinetics, pharmacodynamics, et cetera," he explained. However, he added, "within a Phase III clinical trial, it may be that we are comparing two arms involving existing drugs that are actually potentially billable to insurance, in which case they might be asked to pay for those." Turning to the issue of treatment of complications, which many payors cover for patients enrolled in clinical trials, Dr.
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Ronald Go, of Gundersen Lutheran Health System, suggested that the rarity of off-label cancer treatments in Europe results in faster accruals for clinical trials there compared to the United States.
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Based on his experience in community oncology, Dr. Go suggested to the Cooperative Group chairs that they examine all test criteria currently in place for cancer clinical trials.
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Hagerty explained. Level I consists of the American Medical Association CPT, or common procedural terminology, codes; these cover services and procedures furnished by physicians and other health care professionals, but do not include codes for medical items and services that are billed by other suppliers.
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"I can't imagine us not paying for it," he concluded. PANEL III: INTERACTIONS BETWEEN INDUSTRY, THE FDA, AND THE PUBLICLY FUNDED CANCER CLINICAL TRIALS SYSTEM The workshop's third session examined how private and public sectors and government agencies currently interact within the cancer clinical trials system and explored how these relationships could influence, and be influenced by, implementation of recommendations in the IOM consensus report.
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However, the IOM consensus report identified some challenges in this relationship and proposed ways to address them, Dr. Steinberg noted.
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Steven Shak, of Genomic Health, Incorporated, reminded workshop participants that many important advancements in cancer drug development and patient care have been made possible by diagnostics developed as a result of Cooperative Group studies. For example, the potential value of biomarkers to clinical practice was recognized several decades ago, with the finding by Cooperative Group researchers that targeting the estrogen receptor would provide value to a subgroup of breast cancer patients; similarly, the development of tests to identify breast cancer patients who are likely to respond to Herceptin stemmed from trials conducted by NSABP and NCCTG.
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Noting that the IOM consensus report highlighted prospects for incorporating translational research on biomarkers into cancer clinical trials, Dr. Hohneker reported that most companies are formulating policies that support comprehensive tumor tissue banking, particularly among small populations defined by disease target or tumor type.
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, noted that the increased commitment of the pharmaceutical industry's resources to the field of oncology over the past two decades, along with the international expansion of cancer clinical trials, raises several key needs. First, he said, it is important to recognize that FDA is no longer the sole regulatory authority for cancer clinical trials.
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For example, he asked, should part of the monitoring of the trial be done by the sponsor if it is going to be submitted to a regula tory authority? "I think there deserves to be at least some discussion of some of the other roles that the pharmaceutical industry can play in this arena," he said.
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Becker stated. For the purposes of cancer clinical trials, biomarkers are considered to be devices if they are used to manage patient care, according to Dr.
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. There are possibilities for mitigating or lightening the regulatory load on biomarkers used in cancer clinical trials, Dr.
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OHRP is also working to simplify the process of obtaining informed consent from patients participating in clinical trials -- a need noted in the
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Many stakeholders would say that the part of the cancer clinical trials system most in need of improvement is consent, he observed. "Consent forms are long and complicated and could benefit from some simplification," he explained.
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However, the necessity for NCI review stands as a significant barrier to mutually beneficial collaborations between industry and the Cooperative Groups, he said; the IOM consensus report addressed this concern with its recommendation to streamline and harmonize government oversight and regulation of cancer clinical trials. He therefore asked the panel's industry representatives, "If that recommendation or something like it were to be implemented, would that actually enhance, do you think, the potential for collaboration between the pharmaceutical industry and the Cooperative Groups, at least in circumstances where the Group was the IND holder for the drug under study?
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Therefore, he concluded, a robust cancer clinical trials system is one of appropriately managed flexibility that takes advantage of diversity and different strengths among its component institutions. The pharmaceutical industry faces another key deterrent, in addition to lengthy time lines, to forging public-private partnerships with the Coopera
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The object of such a discussion should be to clarify exactly what is required to prepare a trial for regulatory submission, he said. The designation of a clinical trial as "registrational" simply indicates that if the trial is positive, it will be submitted to the FDA, Dr.
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Hohneker replied. He made note of a recent conference hosted by the Brookings Institution, Friends of Cancer Research, and ASCO, which recommended minimum data standards and guidelines for determining how much data would have to be collected in a clinical trial (Abrams et al., 2009)
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Defining a clinical trial protocol encourages stakeholders to specify its objectives and the prospective hypotheses to be tested, in order to design data collection to accomplish those goals, Dr. Shak observed.
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It requires a proactive, focused set of visionary people to really define them and get everybody else to come along with them." It's somewhat easier to establish a common source of authority with regard to clinical trials than to define standards, Mr. de Vries continued.
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Murphy noted that the need for common data systems for the Cooperative Groups had been recognized for years, but is far from realization, and that without such a common base, the hoped-for efficiencies of consolidation of the Groups could not be achieved. "If we can't have significant progress in achieving these standards and interoperability and data capture forms and clinical trials management systems, where are we?
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By contrast, he said, most systems that are developed today, outside of the world of clinical trials, are created through a much more agile approach, which evolves with time and provides incremental value every time its standards are improved. In fact, Dr.
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Hohneker agreed and noted that pharmaceutical companies have faced similar challenges during frequent recent mergers. "We are all looking at developing standard case report forms .
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Graham Cancer Center, discussed the IOM consensus report's findings and recommendations from the point of view of the Community Clinical Oncology Program. Figure 3 shows the distribution of the 63 CCOP and Minority CCOP sites across the United States and in Puerto Rico, as of June 2010.
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Dr. Grubbs remarked that CCOP physicians would like to see more patient advocates participate in cancer clinical trial design and recruitment.
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Research Foster Research on Risk Assessment and Risk Modeling for Cancer Prevention and Early Detection Explore Funding Mechanisms for Correlative Studies in Association with CPC studies Foster Relationships with Basic Science Researchers Foster Training for Investigators in CPC 2. Maximize Community Resources to Conduct Complex Clinical Trials (Treatment & CPC)
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for MB-CCOPs Incorporate Patient Navigation Foster Development of Mentorship 5. Build on CCOP or MB-CCOP Success to Improve Ability of Community Groups to Accrue Patients Develop Best Practices Develop Process to Rapidly Identify Clinical Trials with Accrual Issues NOTE: Underlined elements are common to the IOM consensus report.
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Grubbs observed. He listed the reasons he and other CCOP physicians participate in the cancer clinical trials system and how their contributions could be further encouraged and
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Grubbs noted, there is a limit to how much time and expense CCOP physicians can contribute to the cancer clinical trials system. "Time and expense versus best patient care options: this is an issue we are going to have to deal with," he said.
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Thomas concluded her remarks by summarizing a "tremendous set of opportunities" afforded by the proposed re-invigoration of the Cooperative Groups, as described in the IOM consensus report. These included the following: Cooperative Groups; of resources on low-accruing trials and to emphasize scientific advancement; 35 See http://cancer.case.edu/notices/files/CooperativeGroupWhitePaper.pdf.
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, California, a recipient of the NCI Community Cancer Centers Program (NCCCP) grant, where she is cancer research manager.
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Community hospital physicians should be included in the planning of clinical trials and incentivized to participate in them, she said. Links between academic and community hospitals should be strengthened, she added; this could be achieved by requiring NCI Comprehensive Cancer Centers to work with the community hospitals in order to obtain funding and to use some of their grant money to fund their community hospital partners.
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At the same time, Mr. Katz expressed concern that management of the Cooperative Group revitalization "lacks the rigor that is the glory of our trials." Drawing an analogy between a clinical trial protocol and the Cooperative Group reorganization plans, he asserted that the latter effort fails to fulfill the criteria used to judge the quality of a clinical trial.
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. we take steps that are irreversible." Comparing the IOM consensus report to a molecule that could, in theory, cure all cancers, he observed that such a drug would never be distributed solely on the basis of its potential.
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These advocates -- who are passionate and more than willing to dedicate their time to advancing cancer research -- want to be part of the discussion of revitalizing cancer clinical trials, she observed. "They have so much to offer," she said.
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,38 Dr. Caligiuri noted that Cancer Centers provide faculty, staff, infrastructure for early 38 The Association of American Cancer Institutes comprises 95 leading cancer research centers in the United States.
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One participant emphasized Dr. Grubbs' earlier point that participating in the Cooperative Groups enables community physicians to collaborate with their academic counterparts, noting that academic Cancer Centers have been encouraged to apply for joint grants to increase accruals of minorities to surgical clinical trials.
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For example, she said, "in pancreatic cancer, there have been 10 years of negative clinical trials, but we only have those because the Cooperative Group pushed to get them done. Many of those studies wouldn't have been done and completed if it weren't for the Cooperative Group." She explained that all the Groups that study gastrointestinal cancers convene twice a year to examine their collective clinical trials portfolio, which offers the possibility of judging the quality of the portfolio that emerges from that process, rather than the number of accruals or number of 39 See http://en.wikipedia.org/wiki/Pareto_principle.
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James Dignam, of the University of Chicago and RTOG, asserted that the 40 percent trial failure rate due to low accrual in cancer clinical trials, which was cited in the IOM consensus report (Cheng et al., 2009; Schroen et al., 2009) , is not the most accurate measurement available.
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An institution that enrolls lots of people in clinical trials, but does not belong to a particular Group, should nonetheless have access to that Group's trials, Mr. Katz responded.
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Schilsky noted that an analysis presented at the March 2011 CTAC meeting determined that annual funding for the entire NCI clinical trials portfolio amounts to nearly $1 billion, of which approximately $250 million supports the Cooperative Groups and the CCOPs. "Where is the other $750 million going?
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"Surely everybody here would agree that it's vitally important to this country that we have a publicly funded clinical trials system," he began. "It's really only a question of how much we invest in it and what it looks like, to make it optimally functional." He noted several ways to improve the current clinical trials system as expressed by workshop participants: new treatments; and As emphasized in the IOM consensus report and reflected in workshop discussions among diverse stakeholders, everyone can do something to improve the cancer clinical trials system, Dr.
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Schilsky added. Many leaders in clinical cancer research "grew up, made their reputations, and learned how to do clinical trials in the Cooperative Group Program," he said.
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89 IMPLEMENTING A NATIONAL CANCER CLINICAL TRIALS SYSTEM sale changes to the system." Anticipating another such workshop in 2012, Dr. Schilsky said he looked forward to seeing how the new Cooperative Group alliances have been forged and how the cancer clinical trials system was changing as a result of these actions.
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