Thesis (M.S.)--University of Wisconsin--Madison, 1962. / Typescript. eContent provider-neutral record in process. Description based on print version record. Includes bibliographical references (leaves 219-230).

No description available.

Pharmaceutical R&D is time-consuming, extremely costly and involves great uncertainty. Although there is a broad range of literature on statistical issues in clinical trials, there is not much that focuses directly on the modelling of pre-clinical research. This thesis investigates models and associated software for improving decisionmaking in this area, building on earlier work by the same research group. We introduce a class of adaptive policies called forwards induction policies for candidate drug selection, and show that these are optimal, with a straightforward solution algorithm, within a restricted setting, and are usually close to optimal more generally. We also introduce an adaptive probabilities model that allows the incorporation of learning from a project’s progress into the planning process. Real options analysis in the evaluation of project value is discussed. Specifically, we consider the option value of investing in clinical trials once a candidate drug emerges from pre-clinical research. Simulation algorithms are developed to investigate the probability distributions of the total reward, total cost, profitability index and the required future resource allocations of a pharmaceutical project under a given allocation plan. The ability to simulate outcome distributionsmeans that we can also compare the riskiness of different projects and portfolios of projects.

No description available.

This dissertation explores the bioethical construction of pregnancy as site of risk and argues that pregnancy is best characterised as sitting in a constant state of tension, as simultaneously healthy-normal-natural and risky. This tension and how it is acknowledged or ignored is a significant factor in many ethical issues centered upon pregnancy. Using a genealogical analysis, this study identifies features of the social discourse around pregnancy that impede clinical research during pregnancy despite both policy changes and educational campaigns emphasising the benefits and importance of such research. The first major finding of the project is the identification of stigma about pregnancy and pharmaceuticals arising out of the mid twentieth century pharmaceutical scandals. This stigma continues to distort the perception of risk during pregnancy, such that the risk of inaction during pregnancy is significantly undervalued and the risk of actions—particularly pharmaceutical interventions—is overestimated. This is related to both the exclusion of pregnant women from pharmaceutical research, and an accompanying tendency towards medical over-intervention in childbirth. The second major finding is how narratives of health and risk construct pregnancy as women’s initiation into ‘responsible motherhood’ and the corresponding surveillance, pressures and expectations that align with the narrative. Pregnant women’s desire to act in their child’s best interest and the knowledge that not only acting or choosing ‘wrong’ may harm their child, make women less inclined to both take risks and/or act outside of conventional norm. This thesis recommends that successful, stakeholder education needs to widen to include a broader range of issues including the effect of stigma upon risk perception, the broader bias towards inaction, and the normative strength of social narratives of good mothering and maternal responsibility. / Thesis / Doctor of Philosophy (PhD) / This dissertation explores the idea of pregnancy as site of risk. It argues that pregnancy is best characterised as a state that is simultaneously healthy and at risk. The tension between these two ways of understanding pregnancy is central to many ethical issues related to pregnancy. This study identifies ideas about pregnancy that impede clinical research during pregnancy. The first major finding of the project is the identification of stigma about pregnancy and pharmaceuticals arising out of the mid twentieth century pharmaceutical scandals. The second major finding is how ideas of health and risk construct pregnancy as women’s initiation into ‘responsible motherhood’ and the corresponding surveillance, pressures and expectations that align with the narrative. This thesis recommends that stakeholder education needs to include a broader range of issues including the effect of stigma, the bias towards inaction, and the role of social narratives of good mothering and maternal responsibility.

Medical Academia Conflict of Interest Policy and Potential Impact on Research Funding by Michael K. Maahs MPA, Troy University, 1993 BA, Ripon College, 1990 Dissertation Submitted in Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy Public Policy and Administration Walden University July 2015 The partnership between medical academia and the pharmaceutical industry has been scrutinized for issues associated with research bias. As a result of this scrutiny, the Institute of Medicine (IOM) issued policy recommendations in 2009 directing academia to adopt comprehensive conflict of interest (COI) policies. During the same time, a slowdown of funded research into academia occurred, and it is not clear whether the IOM recommendations contributed to this problem. The purpose of this case study was to determine the extent to which compliance with the IOM policy resulted in a reduction in funded research. The Advocacy Coalition Framework (ACF) was the theoretical lens used for study. COI policy statements (n = 15) were analyzed from American Association of Medical Colleges member schools that engage in medical research. In addition, in-depth interviews were conducted with 4 medical academic researchers. Data were inductively coded and organized around key themes. Key findings indicated that medical academia is compliant with IOM recommendations and COI policies did not appear to have a direct effect on research placement by industry. Interestingly, a possible explanation for reductions in industry funding relate to inefficient institutional review board processes. Additionally, the ACF construct was validated via an observed complex and slowly evolving COI policy process. The positive social change implications of this study include recommendations to academia to continue to monitor and report on COI and explore efficiency improvements related to IRB oversight in order to support important pharmaceutical research that ultimately improves the health and wellbeing of people.

The partnership between medical academia and the pharmaceutical industry has been scrutinized for issues associated with research bias. As a result of this scrutiny, the Institute of Medicine (IOM) issued policy recommendations in 2009 directing academia to adopt comprehensive conflict of interest (COI) policies. During the same time, a slowdown of funded research into academia occurred, and it is not clear whether the IOM recommendations contributed to this problem. The purpose of this case study was to determine the extent to which compliance with the IOM policy resulted in a reduction in funded research. The Advocacy Coalition Framework (ACF) was the theoretical lens used for study. COI policy statements (n = 15) were analyzed from American Association of Medical Colleges member schools that engage in medical research. In addition, in-depth interviews were conducted with 4 medical academic researchers. Data were inductively coded and organized around key themes. Key findings indicated that medical academia is compliant with IOM recommendations and COI policies did not appear to have a direct effect on research placement by industry. Interestingly, a possible explanation for reductions in industry funding relate to inefficient institutional review board processes. Additionally, the ACF construct was validated via an observed complex and slowly evolving COI policy process. The positive social change implications of this study include recommendations to academia to continue to monitor and report on COI and explore efficiency improvements related to IRB oversight in order to support important pharmaceutical research that ultimately improves the health and wellbeing of people.

This paper details collaboration in elective global health Advanced Pharmacy Practice Experiences (APPEs) between six schools of pharmacy, four in the United States (U.S.) and two in Uganda. This collaboration was initiated to build capacity within Uganda to advance pharmacy practice by strengthening pharmaceutical care education and research, and to provide benefits in the global and public health education and research for U.S. students and each partner University. Makerere University and Mbarara University of Science and Technology in Uganda sought out collaborations to improve pharmacy education in Uganda and alleviate shortages in faculty they have experienced in expanding pharmacy training. In response to this need, Wilkes University, Binghamton University, the University of Minnesota, and East Tennessee State University developed faculty-led APPEs to help model and teach the principles of clinical pharmaceutical care. These faculty-led APPEs occur in various Ugandan locations throughout the year and incorporate Ugandan and U.S. students as co-learners. Ugandan and U.S. faculty act as co-facilitators of didactic, experiential, and research learning experiences. APPE activities include modeling the provision of pharmaceutical care, interprofessional patient care on inpatient wards, joint didactic lectures and case presentations, skills laboratory sessions, and research components. Developed to serve the needs of both the U.S. and Ugandan partners, the elective global health APPEs to Uganda have grown to be sustainable, mutually beneficial collaborations between the six schools of pharmacy and the Ugandan partners. Formal and informal communications between all of the entities involved have helped support continuity of these programs. We recommend such initiatives to other countries and institutions desiring to improve training for pharmaceutical care to advance pharmacy practice.

abstract: With new trends in drug development and testing, it must be determined whether the current state of balance of ethos (the moral norm) and regula (the legal framework) can successfully protect patients while keeping the door to scientific innovation open. The rise of the Clinician Investigator (CI) in both academic and private research introduces a challenge to the protection of subjects in the conflicting dual role of physician and scientist. Despite the constant evolution of regulation and ethical standards, questions about the roles' combined effectiveness in relation to this challenge persist. Carl Elliot describes the suicide of a patient-subject enrolled in an industry-funded physician-run anti-psychotic pharmaceutical drug trial in a 2010 Mother Jones article. Elliot provides a personal account of discrepancies seen in the ethical principles of beneficence, respect for subjects and justice. Through analysis of the problems presented in the case as a model for potential dangers in clinical research, the effectiveness of ethics and law in protecting human subjects is examined. While the lag between ethical standard and regulation has historically shown to cause similar issues, the misconception of current regulation and ethical standards may be contributing to the decrease in subject protections. After IRB approval of subject protections in the research protocol, CIs have been shown to downgrade their responsibility to maintaining ethos through the course of the trial. And, despite their experience in patient-centered ethos as a physician, CIs may be inclined to substitute these values for the ethos of a researcher, with the goal to avoid therapeutic misconception. Maintaining personal responsibility for subjects beyond regulatory structure, and promoting the welfare of the subjects in regards to the ethical standard of research investigators, will provide added security for subjects and decrease opportunity for exploitation in future research. / Dissertation/Thesis / M.S. Biology 2012

Dans quelles conditions s’invente un médicament ? Mue par une démarche pluridisciplinaire, de l'anthropologie de la communication aux Science Studies, cette thèse étudie les stratégies et pratiques communicationnelles mobilisées par l’industrie pharmaceutique et les laboratoires de recherche publics lors de l’invention d’un médicament, dans la phase de recherche qui précède les études cliniques. Ce médicament est une nanoparticule, issue des nanotechnologies, destinée à des applications thérapeutiques (contre le cancer) et diagnostiques (imagerie médicale). Les écosystèmes des réseaux d’innovation sont décrits par une étude ethnographique minutieuse, avec la mise en perspective des interactions multiples qui s’y déroulent.La première partie analyse deux dimensions du contexte général : les discours liés à la recherche pharmaceutique et aux nanotechnologies. Le premier chapitre dissèque les mythes que diffuse l'industrie pharmaceutique à travers ses éléments communicationnels, dont l’origine est la reconfiguration des mécanismes d’innovation des grands groupes. Le second chapitre retrace de manière critique l'histoire des nanotechnologies, dégage les con-troverses à leurs propos et analyse les discours radiophoniques qui leurs sont consacrés. La seconde partie explore trois facettes du local : des chercheurs multi-disciplinaires (chimistes, physiciens, biologistes, médecins), engagés dans la recherche du médicament, travaillent dans des laboratoires publics et privés. Le premier chapitre présente leurs spécificités et observe comment leurs collaborations façonnent des réseaux amorphes. Le second chapitre met en exergue la place centrale de l’oralité, à partir de la synthèse des molécules (i.e. nanoparticules) par les chimistes-physiciens jusqu’à l'expérimentation animale par les médecins-biologistes. Le troisième chapitre analyse comment les chercheurs et leurs concurrents communiquent leurs résultats à travers différents canaux communicationnels (colloque, public de visiteurs, investisseurs et médias). / In which conditions is a drug invented? Driven by a multidisciplinary approach, from Anthropology of Communication to Science Studies, this thesis explores strategies and communication practices mobilized by the pharmaceutical industry and public research laboratories in the invention of a drug in research’s phase that precedes clinical studies. This drug is a nanoparticle based on nanotechnology, for therapeutic applications (against cancer) and diagnostic (medical imaging). Ecosystems of innovation networks are described by a careful ethnographic study with highlighting of multiple interactions that take place there.The first part analyzes two dimensions of global context: the discourse related to pharmaceutical research and nanotechnology. The first chapter dissects the myths that diffuse the pharmaceutical industry through its communicative elements whose origin is the reconfiguration of Big Pharma’s innovation mechanisms. The second chapter summarizes critically the history of nanotechnology, emerging controversies about their analyzes and their radio speeches are devoted.The second part explores three dimensions of local context: multi-disciplinary scientists (chemists, physi-cists, biologists, medical doctors), engaged in drug research, who work in public and private laboratories. The first chapter presents their characteristics and how their collaborations result in amorphous networks. The second chapter highlights the centrality of oral language, from the synthesis of molecules (ie nanoparticles) by chemists, physicists to animal testing by physicians biologists. The third chapter discusses how researchers and their competitors communicate their results through different communicative channels (conferences, public visitors, investors and media).