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Summary of Remarks
Harold Glass, Ph.D. Professor of Health Policy and Pharmaceutical Business "Pharmaceutical Clinical Trials"
September 13, 2006
The study of drug innovation and adoption is a vital part of health policy research. There are a number of important areas to consider regarding this topic, for example, the speed of drug development, the role of the clinical investigator in new drugs, and drug safety. One specific question that has been explored is “how do investigators prescribe after participation in a clinical trial?” This study found that the clinical investigator prescribed more of the trial drug, compared to other drugs in the same class, after the clinical trials were completed. In addition to this finding, this study raised ethical questions regarding the method of payment of clinical investigators; however, it also found that payment method had no relation to prescribing levels post-clinical study.
Additional studies have investigated clinical site performance in multi-national studies and lead to several interesting findings. First, those sites that are better at enrolling study participants start enrolling more quickly and therefore have more time to enroll. Successful sites also start enrolling immediately and use competitive enrollment, such as milestone payments to participants. Finally, the sites with investigators with more clinical and company experience do better in comparison to other sites.
There are many questions that need further investigation, particularly in regards to prescribing patterns, cost effectiveness of clinical trials, and drug safety. The use of drugs to manage various health needs will continue to increase and the drugs will become more aggressive. This consideration highlights the importance of monitoring drug side effects and continuing with drug research guided by clear, answerable questions.
Jennifer Pitonyak, MS, OTR/L
Ph.D. Health Policy Program
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