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DUKE ANESTHESIOLOGY ALUMNUS | 22 DEPARTMENTAL INITIATIVES Global Perioperative Research Organization (GPRO) WHAT IS THE VALUE OF AN ACADEMIC RESEARCH ORGANIZATION? BY MARK NEWMAN CLINICAL TRIALS AND DRUG DEVELOPMENT The process of developing a new drug or device has increased in complexity and cost over the past several decades. Current estimates indicate that drugs that began production in 1995 will have an average development cost of $675 million, and projects that began production in 2001 will have average development costs ranging from $590 million to $880 million. However, the rewards can be very high, with the best-selling drugs generating over $4 billion in sales. Of note, perioperative drugs generate much lower sales, despite similar investments. Considering these facts, there is intense pressure for pharmaceutical companies to control the clinical trials necessary to obtain regulatory approval. The ability to implement and monitor these large-scale clinical trials is frequently beyond the scope or expertise of the pharmaceutical companies themselves. Out of these factors came the development of contract research organizations, commercial groups that work for the pharmaceutical companies and solicit sites to perform the studies, monitor the trials, and provide quality assurance. In concert with the pharmaceutical companies, they frequently control the actual data, analyses, and dissemination of the results. This last issue has led many in the medical establishment to question the appropriateness of this control. A group of senior medical editors from top-tier peer-reviewed journals have issued new conditions for publication whereby at least one author (e.g., the principal investigator) should indicate that she or he “had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.” One solution to this requirement is the increased utilization of academic research organizations.
DUKE ANESTHESIOLOGY ALUMNUS | 23 ACCESS TO THE DATA In their editorial, the editors cited as the impetus for their new criteria recent episodes in which the results of clinical trials were suppressed and in which none of the authors of the manuscripts had access to the original data. An academic research organization, by its very mission, requires access to the data. The editors acknowledge the pharmaceutical sponsors’ right to review and comment on the content of manuscripts but believe that the new requirement for access to data leading to publication in the most prestigious and influential medical journals would further support the peer-review process and insure that the most accurate data are available for the general medical community to base their practice. By requiring access to the data, an academic research organization can also serve an additional important function in generating further knowledge. Individuals frequently enroll in clinical trials for altruistic reasons of improving care in the future. For many clinical trials, once the primary manuscripts on efficacy and safety have been produced, the data are rarely utilized for further analyses, particularly unrelated to the primary intervention of interest. These large databases from multicenter clinical trials have great value in asking and potentially answering important questions related to other aspects of clinical care and would certainly provide information to help generate further hypotheses. An academic research organization can assist investigators in obtaining access to the data and help in performing these secondary analyses. GPRO In response to these needs, the International Anesthesia Research Society (IARS) has selected the Duke Clinical Research Institute (DCRI) and Duke Department of Anesthesiology to create the Global Perioperative Research Organization (GPRO), an Academic Research Organization. Dr. Mark Newman, chairman of the Department of Anesthesiology at Duke, will direct this organization with Dr. Lee Fleisher serving as co-medical director. Duke and Dr. Newman were selected based on their extensive experience in clinical research and ongoing NIH and the American Heart Association funding. Dr. Newman’s research focus was initially on perioperative outcomes in cardiac surgery but has expanded to non-cardiac surgery with welldeveloped sustained relationships with industry sponsors. Dr. Fleisher is the newly appointed chairman of the Department of Anesthesiology at the University of Pennsylvania. GPRO integrates the scientific thought leadership of the IARS and DCRI, as well as the operational capabilities of the DCRI, to develop and share knowledge that improves the care of patients around the world through innovative clinical research. The research focuses on the entire perioperative period, including pain management, critical care medicine, and long-term outcomes assessment. Through collaboration with the DCRI, GPRO has capabilities in site management, data management, statistics, and communications to conduct large multicenter clinical trials. GPRO can deliver added value through a combination of key thought leaders in the early development process and full coordinating center capabilities for clinical trials. There are many ways that a clinician can get involved with GPRO. We offer opportunities to participate in scientifically important research that provides patients with access to novel therapies, the support of experienced research professionals who understand the perspective and needs of site personnel, site-friendly CRFs and study materials, around-the-clock access to clinical support, and regulatory compliance expertise. We believe that GPRO, as an academic research organization, can leverage the intellectual resources of our investigators and specialty leaders to further the aforementioned goals. Furthermore, we can work closely with the pharmaceutical and manufacturing sponsors to insure that the scientific protocol appropriately addresses questions that will improve perioperative care. We welcome your comments as well as your participation in a GPRO trial so that you will also see the virtues of participation in an academic research organization, and the department’s continued commitment to advancing the care of the perioperative patient. Mark F. Newman, MD, is chairman and Merel H. Harmel Professor of Anesthesiology and professor of medicine. He is also medical director of GPRO. DUMC Box 3094 Durham, NC 27710 Office: (919) 681-6646 E-mail: newma005@mc.duke.edu
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