Improving value of clinical research - an evidence-based approach
Matthias Briel, Matthias Schwenkglenks, Christiane Pauli-Magnus, Belinda Von Niederhäusern
2017
unpublished
for their tremendous support at all stages of this thesis. It was a great pleasure to be supported by visionaries who are passionate and convinced in what they do. Both were highly supportive and allowed me to investigate, develop, and grow, both scientifically and personally, in an environment that endorsed trial, creativity, and error. At of the questions being asked, to how the research is designed, conducted, and reported [1, 2,[4][5][6][7]. Seventeen recommendations were addressed to five
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... ain stakeholders -funders, regulators, journals, academic institutions, and researchers. In the same year, Moors et al. [8] suggested a combination of reforms including technological and organizational changes, changes in the regulatory, patent, and reimbursement system, and social and/or political changes to make drug development more sustainable. Approach 2: High quality data High quality research relies on the collection of high quality data. Traditionally, this is done in the inpatient setting or through ambulatory visits to a study site. The widespread availability of new technologies has the potential of shifting some research activities, including enrollment, managing trial activity, reporting results, and safety oversight, away from study sites. Such "remote" research may encourage the participation of a more diverse group of patients in research with improved recruitment rates and at lower costs than those of conventional trials [1-3], and puts individuals, rather than investigative sites, at the center of the research process. However, issues around retention and data quality remain [10,[54][55][56][57][58][59]. Therefore, a combination with direct interactions with the research team may allow remote approaches to be optimally leveraged [8, 9]. While increasing interest and support from definitions, quantitative or qualitative analyses plans for main and secondary objectives, data management plans, monitoring plans, and the requirements plan for a mobile application (TOMACHI). I coordinated the different teams involved in each study including statisticians, data managers, monitors, study nurses, and app developers during the drafting process, and addition to my PhD work, I also had the fantastic opportunity to take over different roles at the CTU, e.g. as maternity cover. For example, I coordinated parts of the Diploma of Advance Studies course and supervised 12 students during their Diploma theses, and managed the roll-out of a pilot study investigating the feasibility of electronic general consent on clinical wards. I am deeply grateful for these diverse opportunities in a very supportive
doi:10.5451/unibas-006766889
fatcat:q75btfmf65fpdhhbu2twzjqfz4