Kenneth A. Getz

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Medical scientists and public health policy makers are increasingly concerned that the scientific discoveries of the past generation are failing to be translated efficiently into tangible human benefit. This concern has generated several initiatives, including the Clinical Research Roundtable at the Institute of Medicine, which first convened in June 2000.(More)
Although it is widely acknowledged that protocol design plays a crucial role in the success of clinical research studies, how protocols have changed over time and the impact of these changes on clinical trial performance have never been quantified. To measure protocol design trends, the Tufts Center for the Study of Drug Development analyzed data on 10,038(More)
The oversight of research involving human participants is widely believed to be inadequate. The U.S. Congress, national commissions, the Department of Health and Human Services, the Institute of Medicine, numerous professional societies, and others are proposing remedies based on the assumption that the main problems are researchers' conflict of interest,(More)
Background Studies indicate that the prevalence of multi-drug resistant infections, including hospital acquired and ventilator associated bacterial pneumonia (HABP/VABP), has been rising. There are many challenges associated with these disease conditions and the ability to develop new treatments. Additionally, HABP/VABP clinical trials are very costly to(More)
PURPOSE The Tufts Center for the Study of Drug Development conducted a study among practicing physicians and nurses (health care providers) across multiple specialties to assess their attitudes and experiences with referring patients into clinical trials and to supplement the body of scholarly research focused primarily on referral practices among(More)
The Food and Drug Administration's MedWatch system--a voluntary surveillance program--received 600,000 adverse event reports on marketed drugs and devices in 2011. The Food and Drug Administration credits the MedWatch system with improving awareness, and expediting early detection, of drug and device risks and in illuminating the adoption of medical(More)
INTRODUCTION The under-reporting of adverse drug events (ADEs) is an international health concern. A number of studies have assessed the root causes but, to our knowledge, little information exists relating under-reporting to practices and systems used for the recording and tracking of drug-related adverse event observations in ambulatory settings,(More)
PURPOSE Articles in peer-reviewed journals and the trade press presuppose that strategic outsourcing relationships have been formed to replace preexisting collaborative approaches with contract research organizations. They do not consider that large, fragmented pharmaceutical and biotechnology companies may be supporting competing and conflicting(More)