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Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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60<br />

BRITISH COLUMBIA<br />

Neonatal Research Program<br />

Neonatology is an area of health care in which decisions can impact dramatically on the future quality<br />

of life of both patients <strong>and</strong> their families. To support this decision process, research is an integral part of<br />

the daily activities in the Program. A core group of health researchers are involved in individual activities<br />

that combine to create a comprehensive, complementary approach to minimizing the long-term<br />

effects of prematurity. The researchers have demonstrated expertise in: basic science (i.e., inflammation<br />

<strong>and</strong> oxidants), clinical research (i.e., r<strong>and</strong>omized controlled trials, neonatal brain imaging), health<br />

services research (i.e., ACoRN-community outreach) <strong>and</strong> population health (i.e., Neonatal Follow-up).<br />

Specific areas of clinical interest are: ventilation <strong>and</strong> critical care therapy, role of immunity <strong>and</strong> genetics<br />

in neonatal disease, nutrition, stress/pain, brain development <strong>and</strong> injury, <strong>and</strong> long-term neurodevelopment.<br />

The Program offers investigators:<br />

• Protocol, informed consent <strong>and</strong> budget review<br />

• Assistance with grant preparation/ submission<br />

• REB preparation <strong>and</strong> submission - including amendments, renewals <strong>and</strong> requests for acknowledgement<br />

• Set-up of study account <strong>and</strong> tracking financial expenses of study<br />

• Data collection, management <strong>and</strong> analysis<br />

• Liaising with pharmacy, laboratory, health records, neonatal intensive care unit (NICU) nursing or<br />

other groups as necessary to help with study initiation<br />

• Hiring <strong>and</strong> training of research staff<br />

• Review, preparation <strong>and</strong> submission of abstracts/manuscripts<br />

• Review/Development of sub-site clinical trial agreements<br />

• Access to the opportunity to conduct Phase I, II, III, <strong>and</strong> IV clinical trials <strong>and</strong> biomedical research<br />

within the NICU, which admits approximately 700 in-patients per year.<br />

The Program includes 13 Principal Investigators as listed below, <strong>and</strong> five Affiliated Investigators. Their<br />

details can be found in Appendix 6. Its structure is shown in Figure A5. It has no independent URL.<br />

Principal Investigators<br />

• Chessex, Philippe (Head)<br />

• Albersheim, Susan<br />

• Holsti, Liisa<br />

• Lavoie, Pascal<br />

• Lupton, Brian<br />

• Miller, Steven<br />

• Osiovich, Horacio<br />

• Sherlock, Rebecca<br />

• Singh, Avash<br />

• Smyth, John<br />

• Solimano, Alfonso<br />

• Synnes, Anne<br />

• Whitfield, Michael<br />

The following table shows all the research interests of each investigator in neonatology, not just clinical<br />

trials:<br />

Disease Focus Types of Studies Investigators<br />

Effects of nutrition, oxidants, <strong>and</strong> antioxidants Animal studies<br />

Chessex, Philippe<br />

on biological markers <strong>and</strong> clinical outcome R<strong>and</strong>omized clinical trials<br />

Ethics <strong>and</strong> decision-making in a vulnerable Qualitative research Albersheim, Susan<br />

population<br />

Stress/pain <strong>Clinical</strong> research Holsti, Liisa

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