Transforming Clinical Research in the United States Challenges and Opportunities: Workshop Summary (2010) / Chapter Skim
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Appendix B Participant Biographies
Appendix B Participant Biographies
Pages 92-106
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From page 92... ...
The initiative, which includes stakeholders from government, industry, academia, patient advocacy groups, professional societies, and other organizations, has the goal of identifying practices whose broad adoption will increase the quality and efficiency of clinical trials.9 In clinical trials, most of the costs are associated with human time and effort, so unnecessary complexity can be both burdensome and expensive. In the United States, where labor costs are higher than in other parts of the world, unnecessarily complex clinical trial processes can put the United States at a disadvantage.
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From page 93... ...
to form communities of research and conduct clinical trials more effectively. SOURCE: Califf, 2009.
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From page 94... ...
Hébert explained that in the United Kingdom, national clinical research networks exist on six major themes, and each includes 7 to 10 local clinical investigator networks. The local networks serve primarily as recruiting centers for large, national trials.
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From page 95... ...
The Internet has been an especially useful tool for trials that require such direct communication with patients. Recruiting patients, communicating study details, and collecting data via the Internet will likely become increasingly useful for conducting clinical trials, according to Lauer.
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From page 96... ...
Historically, PBRNs have been underfunded, but the fact that physicians have joined these networks without the promise of core funding indicates that there is significant interest among practicing community-based clinicians in developing clinical questions and producing research results that can effectively improve everyday clinical practice. Patient advocacy and voluntary health organizations would have an important role in driving the effort to build a national research network.
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From page 97... ...
Creating unified standards for every human measure and the data systems to manage them would help in ensuring that the significant investment each human subject confers in agreeing to participate in a clinical trial results in the highest possible value to the clinical trial enterprise. Involving patients and patient advocates throughout the trial design and implementation process would also help improve clinical trials and the validity of the results they generate.
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From page 98... ...
Numerous gaps exist between the current health care system and the ultimate goal of a learning health care system. The group discussed, for instance, the need to correct public misconceptions about clinical trials and the overall value of clinical research.
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From page 99... ...
could be instrumental not only in improving patient awareness of clinical trial opportunities, but perhaps more importantly, in helping individuals understand the role of clinical research in improving health care. In addition, the clinical research enterprise should be founded on the enthusiasm of providers.
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From page 100... ...
While many individual aspects of the clinical trial process could be enhanced, she focused on the need for a transformational change in the way clinical research is conducted. She described a vision of a clinical research infrastructure in the United States akin to the national highway system or the national energy grid -- in other words, a large public works project designed to ensure that patients, clinicians, and academic researchers all have access to a system that links research and community practice, and facilitates universal participation in the generation of new clinical evidence and its subsequent adoption by physicians.
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From page 101... ...
Workshop participants discussed the many potential benefits of implementing such a vision and the transformational change it would introduce to the clinical research enterprise in the United States. Currently, industrysponsored clinical trials entail the recruitment of individual investigators and the ad hoc creation of a trial infrastructure around the selected investigators.
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From page 102... ...
The U.S. Congress and federal agencies administering health programs throughout the country constantly ask which health care products and procedures to pay for (i.e., what is reasonable and necessary)
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Speaker presentation at the Institute of Medicine Workshop on Transforming Clinical Research in the United States, October 7–8, 2009, Washington, DC.
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Speaker presentation at the Institute of Medicine Workshop on Transforming Clinical Research in the United States, October 7–8, 2009, Washington, DC. Lauer, M
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d. Speaker presentation at the Institute of Medicine Workshop on Transforming Clinical Research in the United States, October 7–8, 2009, Washington, DC.
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