Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research
DIANE Publishing, 2008 - 6 pages
Evaluates the Dept. of Health and Human Services┐ oversight of sponsor and investigator efforts to recruit human subjects for industry-sponsored clinical trials (CT). It focuses on industry-sponsored CT because in recent years industry sponsors have assumed a more prominent role in the search for new drugs. Sponsors and investigators are facing increasing difficulty finding enough subjects in a timely manner to bring drugs to market within their desired time-frame. This report explains the recruitment practices used in industry-sponsored CT for investigational drugs; identifies major concerns about them; and addresses the extent and type of oversight undertaken by institutional review boards and, the FDA, and the NIH.
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Academy of Neurology Academy of Pediatrics accessed December 1999 American Academy American College American Medical Association American Psychiatric Association appropriate recruitment practices authority to review Canadian Tri-Council Policy clinical trials Code of Ethics College of Physicians companion report Conduct for Research Confidentiality of Medical conflicts of interest Council of Canada Department of Health disclose disclosure Dual Investigator-Physician Role Emergency Physicians enrollment Ethical Conduct Federal oversight finder’s fees Health and Human Human Services Industry-Sponsored Clinical Research informed consent institutional review board Internal Medicine Position investigator’s involved in clinical IRB guidelines IRBs and medical IRBs and professional Medical Research Council Mercy Medical Center Ophthalmology Orthopaedic Surgeons Partners HealthCare System patient physician-investigators Position Statement potential conflict Pressures in Industry-Sponsored private medical records professional medical associations recommendations Recruiting Human Subjects recruitment guidelines Recruitment Incentives recruitment issues Research Involving Humans Research Subjects review certain recruiting subject recruitment Tri-Council Policy Statement UCLA University of Rochester Women’s