Clinical research - Perceptions, reality, and proposed solutions
Clinical research - Perceptions, reality, and proposed solutions
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DOI：
10.1001/jama.280.16.1427
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发表时间：
1998-10-28
影响因子：
120.7
通讯作者：
Nathan, DG
中科院分区：
文献类型：
--
作者：
Nathan, DG
背景。-申请美国国立卫生研究院(NIH)临床研究拨款的研究人员中，医生的比例从30年前的40%下降到今天的25%。目标-建议NIH政策变化，以鼓励医生研究人员从事临床研究事业，例如，以患者为中心的研究、流行病学和行为研究、结果研究和卫生服务研究。参与者-NIH主任临床研究小组由来自学术界和行业的14名医生组成，由主任挑选。从1995年7月到1997年11月，他们举行了多次闭门会议和5次公开会议。磋商进程。-除了专家意见和相关文献外，数据来源还包括NIH申请者的培训特点，这些申请者有没有得到资助。审议的议题包括临床研究的融资、未来临床研究人员的招聘、培训和留用、临床试验的进行和临床研究的同行审查，达成了共识，并针对小组成员撰写的一份临时报告达成了共识并提出了建议，该报告包含初步建议。结论-小组向NIH提出的最终建议包括：至少保持NIH临床研究经费的现有比例；继续为医学生提供临床研究的指导机会；通过提供教学课程促进临床研究培训，并向从专业培训计划中脱颖而出的新研究员提供临床研究机会，并为导师提供部分薪酬晚餐；重组审查以患者为导向的研究申请的研究部门，纳入更多医生；鼓励临床研究人员和基础科学家密切合作，促进学术临床研究人员与制药和生物技术公司同事之间的合作；以及在学术健康中心和NIH之间制定支持临床研究和临床研究培训的联合政策。
Context.-The proportion of investigators applying for clinical research grants from the National Institutes of Health (NIH) who are physicians has declined from 40% 30 years ago to 25% today.Objective.-To recommend NIH policy changes that might encourage physician investigators to undertake careers in clinical research, eg, patient-oriented research, epidemiologic and behavioral studies, outcomes research, and health services research.Participants.-The NIH Director's Panel on Clinical Research comprised 14 physicians from academia and industry, chosen by the director. They met in numerous closed sessions and in 5 public meetings from July 1995 to November 1997.Consensus Process.-In addition to expert opinion and pertinent literature, data sources included the training characteristics of applicants to NIH who were funded or not. Topics considered included financing of clinical research, recruitment, training, and retention of future clinical investigators, conduct of clinical trials, and peer review of clinical research, Consensus was reached and recommendations were made in response to an interim report, widely circulated to the biomedical community, written by members of the panel, which contained preliminary recommendations.Conclusions.-The panel's final recommendations to NIH included maintaining at least the present proportion of NIH funding for clinical research; continuing mentored opportunities in clinical research for medical students; promoting clinical research training by offering didactic courses and grant opportunities in clinical research to nascent investigators emerging from specialty training programs and providing partial salary supper: for mentors; restructuring study sections that review patient-oriented research applications to include more physicians; encouraging clinical investigators and basic scientists to work closely together and weld collaborations between academic clinical investigators and colleagues in pharmaceutical and biotechnology companies; and developing a joint policy between academic health centers and NIH for the support of clinical research and clinical research training.