Multi-Center Phase III Clinical Trials and NCI Cooperative Groups Workshop Summary (2009) / Chapter Skim
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Session 1A: Organization of the NCI Clinical Trials System
Session 1A: Organization of the NCI Clinical Trials System
Pages 5-26
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From page 5... ...
. The NCI's CTEP currently supports about 250 Phase I clinical trials, 400 Phase II clinical trials, and between 100 and 150 Phase III clinical trials.
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and the minority CCOP to feed into the cooperative group trials. These CCOPs make up a large network of community-based physicians, including those based in populations with sizable numbers of minorities, which receive financial support from the NCI so that their patients can participate in cooperative group or other NCI-supported clinical trials. CCOPs provide accrual to protocols, which is the enrollment of qualified patients into clinical trials, and some data management and quality control, while affiliate cooperative groups or cancer centers are responsible for developing protocols, data management and analysis, and providing quality assurance.
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It also has a clinical trials infrastructure that is available at any time to test new therapeutic strategies as well as a flexible research agenda that can respond to changing scientific opportunities and new discoveries. Also unique to the Cooperative Group Program is the volunteerism on the part of researchers who support it.
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. Between 1998 and 2007 the number of Phase III cooperative group
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Dr. Abrams described a number of improvements the NCI has made to its Phase III clinical trials programs over the past 10 years, which have made them more efficient and brought them up to date with the current state of the science.
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In addition to creating CTSU to make participation in cooperative group trials more user-friendly and cost-effective, the NCI has also put together state-of-the-art scientific meetings and established diseasespecific steering committees comprised of experts, cooperative group and CCOP members, patient advocates, and community representatives. The steering committees determine the best questions to be addressed by the cooperative group's Phase III trials and the best ways to design those trials.
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He also suggested adding quality assurance representatives to each Phase III clinical trial done in the cooperative groups, in addition to the traditional study co-chairs.
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The centralized, integrated support that Mayo Clinic provides to the NCCTG is extensive and includes: • cientific leadership, with experts in therapeutic interventions, labo s ratory correlative studies, statistics, epidemiology, and quality of life supporting the design, implementation, and analysis of clinical trials; • dministrative support, including grant preparation and manage a ment, budgeting, contracting and legal support, accounting, com munications, and publications; • tatistics and data management, including safety monitoring, data s analysis, statistical design of studies, data collection, quality assur ance and control, and abstract and manuscript preparation; and • perations support, including regulatory support, protocol develop o ment, information technology, site and meeting management, data collection, and quality assurance and control.
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All these review processes ensure that the cooperative group's clinical trials are high quality and scientifically rigorous, Dr. Buckner said, but they also cause protocol development times to be entirely too long.
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Radiation Therapy Oncology Group The next speaker, Dr. Walter Curran, professor and chair of the Department of Radiation Oncology of Emory University School of Medicine, chief medical officer of the Emory Winship Cancer Institute, and chair of the Radiation Therapy Oncology Group (RTOG)
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This group consists of patient advocates and various experts who evaluate every trial concerning its ability to accrue and the likely difficulties of running the trial. BOX 3 Radiation Therapy Oncology Group's Scientific Core Committees • Advanced Technology Integration • Health Services Research and Outcomes • Translational Research Program • Biospecimen Resource • Pathology • Medical Oncology • Medical Physics • Surgical Oncology SOURCE: Curran presentation (July 1, 2008)
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Among the innovations being tested are the use of image-guided radiation therapy and functional imaging to improve the physical targeting of tumors, the combination of targeted chemotherapies with radiation therapy, and the use of molecular biomarkers such as the epidermal growth factor receptor to target radiation therapy or identify those patients most likely to benefit from such therapy. RTOG also conducts translational and analytic research with its unique and interlinked clinical biophysical, biologic, and outcomes databases that enable powerful biostatistical and medical informatics approaches.
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His detailed analysis found that it takes about 810 steps to open a Phase III cooperative group clinical trial, with 68 of those steps having an opportunity for looping that would involve additional revision and review steps. As many as 38 separate groups or individuals can be involved in a study before it receives its first patients, Dr.
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The median time it takes to open a Phase III cooperative group clinical trial currently is 2.5 years, but that time can vary from 1.25 years to almost 7 years, Dr. Dilts reported (Dilts and Sandler, 2006; Dilts et al., 2006, 2008)
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In the remainder of his talk, Dr. Dilts discussed ways to remedy the inefficiencies that cause long development times for clinical trials and affect their success in meeting minimum patient accrual levels.
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Joseph Aisner, professor of medicine, chief medical officer, and director of the Thoracic Oncology Program at the New Jersey Cancer Institute, raised his concern that streamlining the number of clinical trials will adversely affect research on rare or pediatric tumors, where there are now three protocols activated institutionally for every patient accrued.
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D Anderson Cancer Center, raised the possibility that there was a link between the high costs of running clinical trials and low accrual rates.
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Dilts said. Also discussed was whether increased government involvement in cooperative group trials is causing unnecessary delays in clinical trial start-up times.
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Of increasing importance is the bigger question of who will pay for the study. The NCI pays only for some expenses involved in running a clinical trial and often does not pay for research-related tests that health insurers are also not likely to reimburse.
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Schilsky's presentation, Dr. Scott Ramsey, full member of the Cancer Prevention Program in the Division of Public Health Science at the Fred Hutchinson Cancer Research Center, suggested that when evaluating clinical trial protocols, in addition to considering the scientific merit and operational complexity of the study, that a third category he called "clinical relevance" also be considered.
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Califf noted that Duke University seldom uses central IRBs for its clinical trials but instead often uses commercial IRBs, which "just do the job without all the rigamarole we typically have inside the academic centers." He continued, "I think the facilitated IRB is a much better approach, because if you turn over everything to one central IRB and if it does a stupid thing, the entire machine is shut down, whereas beaming people in by teleconference, etc., gives everybody the benefit of expert review without totally giving up local control." During a later presentation, Dr. Renzo Canetta, vice president of oncology global clinical research at Bristol–Myers Squibb, concurred that "the central IRB is not the magic solution in terms of time saved.
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From page 26... ...
Markman pointed out that federally funded research falls under the regulation of the Office for Human Research Protections (OHRP) , but non-federally funded research, such as clinical trials sponsored by industry, does not fall under OHRP's mandate.
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