The FDA Clinical Trial Process: Effectuating Change in the Regulatory Framework Governing Clinical Trials to Account for the Historical Shift From "Traditional" to "New" Phase I Trials
Aldes, Jamie L
Health matrix (Cleveland, Ohio : 1991) 2008 Summer; 18(2): 463-500
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Safeguarding Clinical Trials. Efforts Are Underway to Modernize Clinical Trial Standards and Normalize Regulations to Facilitate International Collaboration. but as the European Union's Clinical Trials Directive Shows, a One-Size-Fits-All Regulatory Strategy May Be Easier to Conceive Than to Implement Unknown creator (2007-02)
Macaluso, Matthew; Krams, Michael; Preskorn, Sheldon H (2011-05)Phase I clinical trials have traditionally been focused on populations of normal healthy volunteers with the goal of determining the safety, tolerability, and pharmacokinetic profile of new investigational agents. As CNS ...
Involvement and (Potential) Influence of Care Providers in the Enlistment Phase of the Informed Consent Process: The Case of AIDS Clinical Trials Mueller, Mary-Rose (2004-01)This article draws on ethnographic field data collected during an investigation of the informed consent process and AIDS clinical trials. It describes the involvement of care providers (physicians, nurse practitioners, ...