Transforming Clinical Research in the United States Challenges and Opportunities: Workshop Summary (2010) / Chapter Skim
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4 Clinical Trials in Cardiovascular Disease
4 Clinical Trials in Cardiovascular Disease
Pages 29-38
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From page 29... ...
The importance of involving knowledgeable staff throughout a study was highlighted in a discussion of cardiovascular and depression clinical trials. Califf referred to the crucial role of a well-trained, intelligent data monitoring committee tasked with evaluating interim trial results.
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From page 30... ...
In the case of an academic institution conducting a clinical trial for a pharmaceutical company, the internal review processes of both organizations are involved. In addition to such internal requirements, myriad federal and state regulatory requirements affect the conduct of clinical trials.
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From page 31... ...
institutions is one reason industry sponsors look outside the United States to initiate studies. Institutional Review Board Approval Gaining IRB approval is a requirement of the clinical trial process.3 Lane's survey of intramural NIH investigators revealed that the top four barriers to clinical research are: • Ethical/IRB approval, • scientific review/protocol approval, • interaction with industry and issues with technology transfer, and • adequacy of resources.
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From page 32... ...
Because multiple IRB approvals are required for most large, multisite clinical trials, these inconsistencies in IRB determinations and standards across the country complicate and delay the process of conducting a clinical trial and can inhibit the ability of investigators to implement the same trial protocol across all study sites -- a critical factor for developing valid trial results. Informed Consent Informed consent refers to the process and documents associated with educating individuals on the details of a clinical trial and potentially gaining their consent to participate in the study.5 Obtaining informed consent from each subject in a clinical trial requires a significant amount of time.
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From page 33... ...
, commented that if clinical trials are subject to significant delays, the standard of care can move on in the absence of phase III data. Thus, obstacles and delays in clinical trials move health care further away from evidence-based practice.
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From page 34... ...
Among the problems they reported, many sites were not conducting critical study procedures correctly or entering all of the data required by the study protocol. According to Woodcock, poor understanding of the study protocol is a common problem in clinical trials and can lead to sloppy data collection and poor data quality.
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From page 35... ...
Thus, according to these survey results, patients' preconceived notions about trial participation could pose a barrier to clinical trial enrollment. Greenbaum noted that the socioeconomic status of patients plays a role in whether they decide to enroll in clinical trials.
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From page 36... ...
Canetta reported that the ability to recruit patients into a trial successfully is similar for the pharmaceutical industry and NCI. Regardless of the trial sponsor, recruitment of patients who meet the requirements of the protocol is difficult: in one study of 14 cancer centers approximately 50 percent of study sites failed to recruit a single patient (Durivage et al., 2009)
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From page 37... ...
Presentations summarized in this chapter described a number of different approaches to conducting clinical research in the area of cardiovascular disease and illuminated the overall evolution of clinical trials in this area as compared with other disease areas. This first of four chapters on clinical trials in disease-specific areas begins with a discussion of clinical research models for coronary syndromes.
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From page 38... ...
Robert Califf, Vice Chancellor for Clinical Research and Director of the Duke Translational Medicine Institute, reflected on the notable successes of the ACS field in translating basic science into early clinical trials, and then into definitive trials that evaluate outcomes related to key clinical questions. Once effective treatments have been identified and disseminated, the final step is measuring their uptake in hospitals and making the results publicly available, which improves adherence to the treatments.
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