Transforming Clinical Research in the United States Challenges and Opportunities: Workshop Summary (2010) / Chapter Skim
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8 Building a Robust Clinical Trials Infrastructure
8 Building a Robust Clinical Trials Infrastructure
Pages 68-80
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From page 68... ...
All phase III treatment trials sponsored by NCI's Clinical Trials Cooperative Group Program are evaluated, prioritized, and approved by those committees. Standardization and promotion of common tools.
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From page 69... ...
NCI is reviewing strategies for im proving the speed with which trials are initiated and conducted and is focusing on two key areas: • Bottlenecks in trial development -- A recent study (Dilts et al., 2009) found that for NCI-sponsored phase III clinical trials, the time from concept submission to trial activation by a cooperative group re quired a median of 602 days.
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From page 70... ...
Efforts are currently under way to bring the company's timeline for internal review down to 5 months by aligning review cycles with various internal functions. The time to activate a clinical trial protocol varies across institutions and clinical trial sponsors.
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From page 71... ...
Jay Skyler, Chairman of the Type 1 Diabetes TrialNet, explained that individuals are born with a genetic predisposition to type 1. Autoimmune, genetic, and environmental factors are believed to play a role in the immune system's attack on insulin-producing beta cells and the development of this form of the disease (NDIC, 2008)
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From page 72... ...
In addition, a significant amount of money is flowing during the trial design process, and contracts and negotiations surrounding these financial transfers can affect general progress on trial development. Fradkin explained that the RFA process for identifying diabetes trial investigators has advantages that include the diverse expertise that is brought to bear in the trial design phase and the rigorous, iterative process of site selection, which has resulted in highly robust multicenter clinical trials that have transformed diabetes therapy.
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From page 73... ...
Thus, disadvantages of the RFA process are its length, uncertainty regarding the feasibility of the trial design, and the undetermined budget. NIDDK recently tried a new approach to conducting diabetes clinical trials -- the investigator-initiated planning grant.
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From page 74... ...
For example, different type 2 diabetes patients have different combinations of insulin resistance and decreased beta cell function. When these heterogeneous manifestations of the disease are combined into a single group based on a given glycemic level for the purposes of a clinical trial, the opportunity to identify patients who benefit from a particular therapeutic approach can be lost.
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From page 75... ...
Given NIDDK's track record in conducting paradigm-shifting diabetes trials in diverse populations, conducting clinical trials in the Medicare population could offer an opportunity for cost savings. NIH would pay the research costs, CMS would pay the costs of providing clinical care, and the trial results would have the benefit of being conducted in a real-life health care setting.
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From page 76... ...
To complete the process, the TrialNet Chairman's Office, the Coordinating Center, center directors, and trial coordinators implement the protocol and carry out the study. According to Skyler, his experience in conducting clinical trials in type 1 diabetes suggests, first, that clinical decisions should be based not on 1 Additional information on TrialNet can be found at http://www.diabetestrialnet.org/index.
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From page 77... ...
ADOPT was a landmark clinical trial that changed first-line treatment decisions in favor of drugs that maintain glucose control to a greater degree. It was also unique for the pharmaceutical industry to engage in a comparative effectiveness study that explored issues beyond whether a drug can lower glucose.
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From page 78... ...
Any problems could be dealt with quickly through the network of committees overseeing the trial. Managing a relatively complex organizational structure by means of a 25-member Steering Committee and the Protocol Oversight Program, NIDDK was able to maintain tight control over the conduct of the trial and ensure compliance with the trial protocol.
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From page 79... ...
) and an industry-sponsored randomized controlled trial (A Diabetes Progression Outcomes Trial [ADOPT]
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From page 80... ...
OVERCOMING REGULATORY CHALLENGES In addition to the challenges discussed in Chapter 3, Carla Greenbaum, Director of the Benaroya Research Institute Diabetes Program and Clinical Research Center, reflected on her experience conducting clinical trials
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