Implementation of timeline reforms speeds initiation of National Cancer Institute-sponsored trials
| Autor: | James H. Doroshow, Ray A. Petryshyn, Kate J. Dipiazza, Jeffrey S. Abrams, Gini F. Fleming, Gabriel N. Hortobagyi, Andrea Denicoff, Patricia R. Schettino, Martha Kruhm, Laurence A. Baker, Shanda Finnigan, Nancy I. Soto, Margaret M. Mooney, Steven H. Friedman, Edward L. Korn, Brian L. Zuckerman, Ralph M. Meyer, Sherry S. Ansher, Mike Montello, D. Lawrence Wickerham, James C. Yao, R. Rita Misra, Oren Grad, Jan C. Buckner, Sheila A. Prindiville, Robert T. O'Donnell, Erin Souhan, James A. Zwiebel, Bruce J. Giantonio, Judith A. Hautala, Daniel M. Sullivan |
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| Rok vydání: | 2013 |
| Předmět: |
Cancer Research
medicine.medical_specialty Time Factors Guidelines as Topic Article Patient safety Clinical Trials Phase II as Topic Cancer Therapy Evaluation Program medicine Humans Multicenter Studies as Topic Medical physics Pharmaceutical industry Clinical Trials as Topic Clinical Trials Phase I as Topic business.industry Investigational New Drug Timeline Institutional review board National Cancer Institute (U.S.) United States Clinical trial Oncology Drug development Clinical Trials Phase III as Topic business |
| Zdroj: | Journal of the National Cancer Institute. 105(13) |
| ISSN: | 1460-2105 |
| Popis: | The Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI) has long sponsored an oncology drug development effort whose size and scope is unique among National Institutes of Health institutes. NCI’s program complements commercial pharmaceutical plans by expanding research opportunities and by filling gaps in drug development that are unmet by the private sector. When new agents are ready for the clinic, NCI forms partnerships with either industry or academic institutions to bring their new molecules to NCI-sponsored clinical trial networks. NCI’s role in these studies may include filing an investigational new drug (IND) application with the US Food and Drug Administration, distributing experimental agents to trial sites, reviewing the experimental protocol, and monitoring adverse event reports on NCI IND agents to assure patient safety. Investigators in NCI-supported networks are responsible for proposing ideas, developing protocols, and conducting the trials, including data management, analysis, and publication. Both early phase I–II trials and later phase III randomized, controlled trials are conducted in NCI-supported Comprehensive Cancer Centers, other academic medical centers, community practices, and NCI-sponsored cooperative groups and consortia across the country. Although fully acknowledging that NCI-sponsored trials have made many important contributions to oncology practice, several recent independent reviews (1,2) expressed concern over the inordinately long time required for implementing these studies because of the multilayered, sequential review processes. Overly long development can render trials outdated by the time they are available for patient enrollment and can considerably delay bringing new treatments to patients in need (1). If delays in activating trials were not addressed, the reviews (1–4) warned that the overall NCI clinical trials effort could be severely compromised (1–4). These concerns led the NCI to reassess how its clinical trials were developed, reviewed, and implemented. Sponsors, government regulators, funders, patient advocates, and investigators all have responsibilities that traditionally have led to multiple, iterative review processes before a trial is launched (5). Recognizing that new approaches were urgently required, NCI formed an Operational Efficiency Working Group (OEWG) in 2008 that included all the critical stakeholders involved in the protocol development and approval process for NCI-supported trials. The March 23, 2010 OEWG report, “Compressing the Timeline for Cancer Clinical Trial Activation,” provided comprehensive strategies to decrease the time required to activate NCI-sponsored clinical studies (3). Although this effort took nearly 2 years to complete, it resulted in a broad-based, strategically driven plan that involves all the critical stakeholders in the cancer clinical trials community. One essential OEWG recommendation was the establishment of both target timelines and absolute deadlines for trials as they transit from submission of an idea to trial activation (trial activation is defined as “open to patient enrollment at one or more institutions”). The target timeline was intended to represent an optimal scenario where each step in the process was achieved with great efficiency and resulted in very rapid protocol implementation (Figure 1). The absolute deadline is the maximum number of (calendar) days a trial is allotted from submission of a proposal to trial activation. For phase I–II studies and phase III studies, the target timelines are 7 months and 10 months, whereas the absolute deadlines were set at 18 and 24 months, respectively. Trials that do not activate before the absolute deadline are automatically disapproved. The target timeline, however, is the primary goal that NCI staff and the extramural investigators strive to achieve. It was agreed that target timelines for early- and late-phase studies needed to be aggressive and required a major improvement over past performance. OEWG members representing the pharmaceutical industry felt that these target timelines should be consistent with expectations in industry-sponsored studies. Figure 1. Key steps in the National Cancer Institute (NCI) clinical trial review process. FDA = US Food and Drug Administration; IRB = institutional review board; LOI = letter of intent. |
| Databáze: | OpenAIRE |
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