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 author (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 ...
Decision-Making Process in Patients Before Entering Phase III Cancer Clinical Trials: A Pilot Study Huizinga, Gea A.; Sleijfer, Dirk Th.; van de Wiel, Harry B.M.; van der Graaf, Winette T.A. (1999-04)The present study was performed to gain insight into the decision-making process that patients go through when asked to participate in a cancer clinical trial. Fourteen cancer patients entered a pilot study concerning ...