Expediting clinical trials in a pandemicBMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b4652 (Published 10 November 2009) Cite this as: BMJ 2009;339:b4652
- Andrew J Pollard, professor of paediatric infection and immunity1,
- Amanda Reiner1,
- Tessa John1,
- Elizabeth Sheasby2,
- Matthew Snape1,
- Saul Faust3,
- Andrew Collinson4,
- Adam Finn5,
- Paul T Heath6,
- Elizabeth Miller2
- 1Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford OX3 9DU
- 2Immunisation Department, Centre for Infection, Health Protection Agency, Colindale
- 3University of Southampton Wellcome Trust Clinical Research Facility, Southampton
- 4Royal Devon and Exeter NHS Foundation Trust, Exeter
- 5Bristol Children’s Vaccine Centre, University of Bristol, Bristol
- 6St George’s Vaccine Institute, University of London, London
In response to the urgent need for paediatric data comparing the two new variant A/H1N1 vaccines in the UK before the onset of a second wave of flu,1 and a call for proposals related to new variant A/H1N1 by the National Institute for Health Research (NIHR),2 we designed a clinical trial of immunogenicity and tolerability in children aged 6 months-12 years. We submitted a collaborative funding application to NIHR on 24 July 2009, receiving an award letter on 1 September. We redeployed trials staff, funded variously by the agencies given in this letter, to prepare submissions for ethical, regulatory, and NHS research and development approval.
Prioritisation of the review process and dialogue between investigators and senior staff in the reviewing agencies allowed rapid review and resolution of queries. Oxfordshire research ethics committee reviewed the application three days after submission, providing written approval 18 days later. Clinical trials authorisation was submitted to the Medicines and Healthcare Regulatory Agency (MHRA), including dossiers provided by the manufacturers, on 11 September, with written approval received after seven days; NHS research governance approval was received after 19 days. Two separate substantial amendments to the protocol were also reviewed and approved by both the ethics committee and MHRA within 48 hours.
The first vaccine was given on 26 September, and by the end of the first week almost 500 children had been enrolled, just over 4 weeks after the study’s initial submission for ethical and regulatory review. We expect to enrol almost 1000 children four weeks after giving the first dose of vaccine.
These efforts to start important H1N1 trials are unprecedented and show a welcome responsiveness. Despite the expedited process, the bureaucratic burden was undiminished. The capacity of trials staff funded by NIHR proved essential, supporting the need for NIHR to invest in the clinical trials infrastructure. Evaluation of these exceptional processes should help to improve timelines for setting up clinical trials beyond a pandemic threat.
Cite this as: BMJ 2009;339:b4652
Competing interests: All authors are involved in the delivery of clinical trials of vaccines on behalf of their institutions and believe that both commercial and non-commercial trials will benefit from improved timelines for review and set up of trials in the UK. Their employing institutions receive research funding for clinical trials from many pharmaceutical and vaccine manufacturers that might benefit from improved delivery of clinical research in the UK.