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Phase I studies: the role of publicly funded academic-healthcare partnerships

Phase I studies: the role of publicly funded academic-healthcare partnerships
Phase I studies: the role of publicly funded academic-healthcare partnerships
Emanuel and colleagues’ meta-analysis found that phase I studies are very safe.1 However, the accompanying editorial mentioned that phase I studies are a “secret realm” and that “most studies are conducted outside academic medical centres at private facilities run by pharmaceutical companies or contract research organisations.”2

After a major safety problem at a commercial phase I facility in 2006,3 the UK Medicines and Healthcare products Regulatory Agency (MHRA) introduced an accreditation scheme to enhance phase I safety standards in the UK. There are now four publicly funded phase I accredited clinical research facilities in the UK that have been open to non-commercial facilities since 2013. These include one university-hospital partnership (the Southampton National Institute for Health Research (NIHR) Wellcome Trust Clinical Research Facility) funded by the National Institute for Health Research. This provides an environment for early phase studies within the heart of an acute NHS hospital along with academic input from local university investigators. Phase I studies in patient populations and healthy volunteers are a crucial part of drug development. The UK Department of Health NIHR experimental medicine infrastructure has created a setting that delivers industry and publicly funded phase I trials while allowing recruitment from the entire UK population.
0959-8138
Brendish, Nathan J.
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Gbesemete, Diane F.
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de Graaf, Hans
447e78ed-346f-45bb-9238-fce2118d5559
Edwards, Christopher J.
dcb27fec-75ea-4575-a844-3588bcf14106
Faust, Saul N.
f97df780-9f9b-418e-b349-7adf63e150c1
Brendish, Nathan J.
1c73d43e-79fb-4c3a-88bc-08207d3c3ba8
Gbesemete, Diane F.
17afda02-c7ee-4711-9c1e-8ced94a77fd5
de Graaf, Hans
447e78ed-346f-45bb-9238-fce2118d5559
Edwards, Christopher J.
dcb27fec-75ea-4575-a844-3588bcf14106
Faust, Saul N.
f97df780-9f9b-418e-b349-7adf63e150c1

Brendish, Nathan J., Gbesemete, Diane F., de Graaf, Hans, Edwards, Christopher J. and Faust, Saul N. (2015) Phase I studies: the role of publicly funded academic-healthcare partnerships. British Medical Journal. (doi:10.1136/bmj.h3889). (PMID:26202793)

Record type: Article

Abstract

Emanuel and colleagues’ meta-analysis found that phase I studies are very safe.1 However, the accompanying editorial mentioned that phase I studies are a “secret realm” and that “most studies are conducted outside academic medical centres at private facilities run by pharmaceutical companies or contract research organisations.”2

After a major safety problem at a commercial phase I facility in 2006,3 the UK Medicines and Healthcare products Regulatory Agency (MHRA) introduced an accreditation scheme to enhance phase I safety standards in the UK. There are now four publicly funded phase I accredited clinical research facilities in the UK that have been open to non-commercial facilities since 2013. These include one university-hospital partnership (the Southampton National Institute for Health Research (NIHR) Wellcome Trust Clinical Research Facility) funded by the National Institute for Health Research. This provides an environment for early phase studies within the heart of an acute NHS hospital along with academic input from local university investigators. Phase I studies in patient populations and healthy volunteers are a crucial part of drug development. The UK Department of Health NIHR experimental medicine infrastructure has created a setting that delivers industry and publicly funded phase I trials while allowing recruitment from the entire UK population.

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Published date: 22 July 2015
Organisations: Clinical & Experimental Sciences

Identifiers

Local EPrints ID: 380713
URI: https://eprints.soton.ac.uk/id/eprint/380713
ISSN: 0959-8138
PURE UUID: 571f50e5-6bd3-491b-89d7-a1ebc1f7b745
ORCID for Saul N. Faust: ORCID iD orcid.org/0000-0003-3410-7642

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Date deposited: 03 Sep 2015 14:16
Last modified: 20 Jul 2019 00:54

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