Phase I studies: The role of publicly funded academic-healthcare partnerships
We read with interest the meta-analysis finding that phase I studies are very safe. [1] However, the accompanying editorial mentions both 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]
Following a major safety issue 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. Open to non-commercial facilities since 2013, there are now 4 publicly funded phase I accredited Clinical Research Facilities in the UK, including one university-hospital partnership (the Southampton NIHR Wellcome Trust Clinical Research Facility) funded by the National Institute for Health Research. This provides an environment for early phase studies embedded in the heart of an acute NHS hospital with all of the associated academic input from local university investigators. Phase I studies in patient populations as well as healthy volunteers are a critical 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 whilst allowing recruitment from the entire UK population.
1. Emanuel E, Bedarida G, Macci K, et al. Quantifying the risks of non-oncology phase I research in healthy volunteers: meta-analysis of phase I studies. BMJ 2015;350:h3271. doi:10.1136/bmj.h3271
2. Kimmelman J. The secret realm of phase I trials in healthy volunteers. BMJ 2015;350:h3444. doi:10.1136/bmj.h3444
3. Suntharalingam G, Perry MR, Ward S, et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 2006;355:1018-28
Competing interests:
NJB, HdG and DFG are Clinical Research Fellows and CJE and SNF the Directors of the Southampton NIHR Wellcome Trust Clinical Research Facility
09 July 2015
Nathan J Brendish
Clinical Research Fellow
Diane F Gbesemete, Hans de Graaf, Christopher J Edwards, Saul N Faust
Southampton NIHR Wellcome Trust Clinical Research Facility
University Hospital Southampton NHS Foundation Trust, Southampton General Hospital, Tremona Road, Southampton SO16 6YD, UK
Rapid Response:
Phase I studies: The role of publicly funded academic-healthcare partnerships
We read with interest the meta-analysis finding that phase I studies are very safe. [1] However, the accompanying editorial mentions both 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]
Following a major safety issue 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. Open to non-commercial facilities since 2013, there are now 4 publicly funded phase I accredited Clinical Research Facilities in the UK, including one university-hospital partnership (the Southampton NIHR Wellcome Trust Clinical Research Facility) funded by the National Institute for Health Research. This provides an environment for early phase studies embedded in the heart of an acute NHS hospital with all of the associated academic input from local university investigators. Phase I studies in patient populations as well as healthy volunteers are a critical 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 whilst allowing recruitment from the entire UK population.
1. Emanuel E, Bedarida G, Macci K, et al. Quantifying the risks of non-oncology phase I research in healthy volunteers: meta-analysis of phase I studies. BMJ 2015;350:h3271. doi:10.1136/bmj.h3271
2. Kimmelman J. The secret realm of phase I trials in healthy volunteers. BMJ 2015;350:h3444. doi:10.1136/bmj.h3444
3. Suntharalingam G, Perry MR, Ward S, et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 2006;355:1018-28
Competing interests: NJB, HdG and DFG are Clinical Research Fellows and CJE and SNF the Directors of the Southampton NIHR Wellcome Trust Clinical Research Facility