Trial Design: Ensuring Efficiency & Effectiveness in ResearchKGI Professor of Practice in Clinical & Regulatory Affairs Search Seminar
Irina Kulinets, RAC, Six Sigma Black Belt, CQE
Clinical research is one of the most crucial and expensive stages of medical products development especially drugs. The clinical research and, specifically design of clinical trials needs to be carefully strategized.
Major challenges to current clinical research, such as dramatic reduction in the approval of new drugs by FDA, existing generic competition, impending loss of major patents, relatively thin pipeline, and stricter safety standards for new drug approvals (recent withdrawals and black-box warnings) can be addressed by carefully tailored strategy and design. Clinical studies should be thoughtfully planned to limit failures due to poor clinical design or strategy, enhancing the potential of faster bringing the product to the market.
The presentation discusses clinical research types and parameters, briefly stops on the protocol design features, and focuses on optimization measures for all phases of the clinical trials. It is followed by the examples of the appropriate various study designs that are effective and efficient.
Please bring your lunch - we'll provide cookies and drinks
Support for this Series provided by Simon and Virginia Ramo
|Where:||KGI Main Campus, Bldg. 535, Rm. 152|
|When:||October 21, 2010, 12:00 p.m. - 1:00 p.m.|