Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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60 BRITISH COLUMBIA Neonatal Research Program Neonatology is an area of health care in which decisions can impact dramatically on the future quality of life of both patients and their families. To support this decision process, research is an integral part of the daily activities in the Program. A core group of health researchers are involved in individual activities that combine to create a comprehensive, complementary approach to minimizing the long-term effects of prematurity. The researchers have demonstrated expertise in: basic science (i.e., inflammation and oxidants), clinical research (i.e., randomized controlled trials, neonatal brain imaging), health services research (i.e., ACoRN-community outreach) and population health (i.e., Neonatal Follow-up). Specific areas of clinical interest are: ventilation and critical care therapy, role of immunity and genetics in neonatal disease, nutrition, stress/pain, brain development and injury, and long-term neurodevelopment. The Program offers investigators: • Protocol, informed consent and budget review • Assistance with grant preparation/ submission • REB preparation and submission - including amendments, renewals and requests for acknowledgement • Set-up of study account and tracking financial expenses of study • Data collection, management and analysis • Liaising with pharmacy, laboratory, health records, neonatal intensive care unit (NICU) nursing or other groups as necessary to help with study initiation • Hiring and training of research staff • Review, preparation and submission of abstracts/manuscripts • Review/Development of sub-site clinical trial agreements • Access to the opportunity to conduct Phase I, II, III, and IV clinical trials and biomedical research within the NICU, which admits approximately 700 in-patients per year. The Program includes 13 Principal Investigators as listed below, and five Affiliated Investigators. Their details can be found in Appendix 6. Its structure is shown in Figure A5. It has no independent URL. Principal Investigators • Chessex, Philippe (Head) • Albersheim, Susan • Holsti, Liisa • Lavoie, Pascal • Lupton, Brian • Miller, Steven • Osiovich, Horacio • Sherlock, Rebecca • Singh, Avash • Smyth, John • Solimano, Alfonso • Synnes, Anne • Whitfield, Michael The following table shows all the research interests of each investigator in neonatology, not just clinical trials: Disease Focus Types of Studies Investigators Effects of nutrition, oxidants, and antioxidants Animal studies Chessex, Philippe on biological markers and clinical outcome Randomized clinical trials Ethics and decision-making in a vulnerable Qualitative research Albersheim, Susan population Stress/pain Clinical research Holsti, Liisa
CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP 61 Disease Focus Types of Studies Investigators Role of immunity and genetics in neonatal Basic science Lavoie, Pascal disease Clinical research Quality Improvement Lupton, Brian Brain development and injury Clinical research Miller, Steven Advanced MRI technologies Critical care therapies Clinical research Osiovich, Horacio Neonatal ventilation Epidemiology Sherlock, Rebecca Randomized clinical trials Critical care therapies Pharmaceutical trials Singh, Avash Critical care therapies Clinical research Smyth, John Ventilation and critical care therapies Education & knowledge translation Solimano, Alfonso Long-term neurodevelopmental outcome Knowledge translation Long term follow-up KT methodologies Synnes, Anne Long-term neurodevelopmental outcome Long term follow-up Whitfield, Michael FIGURE A5. Neonatal Research Program Division Head: Chessex, Philippe Principal Investigators Research Manager: Jennifer Claydon Lead Research Coordinators Data Abstractors Lab Manager Science Writer Study Nurses/ Research Assistants Student/ Lab Assistant Staffing of the Neonatal Research Program is as follows: Study Nurses/ Research Assistants Data Abstractors Pharmacy Staff Laboratory Staff Admin. Coordinators 1 3 12 1 2 0 4* 2** * 1 Manager, 1 assistant, 2 co-op students. ** 1 Manager, 1 science writer.
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