Helen is a Senior Clinical Research Associate Respiratory Research, Department of Clinical Sciences at Liverpool School of Tropical Medicine.
Helen has 15 years research experience including regulatory Clinical Trials of Investigational Medicinal Products (CTIMP) in both paediatrics and adults, also, a trial Genetic Modification of Organisms (GMO) regulated by Department for Environment Food and Rural Affairs (DEFRA).
Helen’s recent portfolio of studies includes:
- Experimental Human Pneumococcal Challenge (EHPC) Model (inoculation of healthy volunteers and bronchoscopy),
- COVID -19 Oxford Vaccine Trials (as Co-Principal Investigator)
- COVID – SAFER Study monitoring antibodies in health workers.
- GMO attenuated pneumococcal strains (Co-Investigator)
- Respiratory Syncytial Virus Surveillance (Co-Principal Investigator)
- Pharmacokinetics and pharmacodynamics of neonatal and infants administered the antibiotic ciprofloxacin for sepsis in critical care.
This portfolio of challenging studies were successfully completed on time and to target. The EHPC team safely challenged over 1800 participants with live bacteria in over 30 clinical studies at the Accelerator Research Clinic. The other studies involved extensive collaboration with NHS Hospitals Nd Primary Care.
As Chief of Operations and Co-Principal Investigator for the Oxford Astra Zeneca Vaccine trial during the covid-19 pandemic at LSTM we achieved the highest recruitment nationally. We set up the trial as a site within 3 weeks, recruited 600 participants within a month and continued to lead two further trials of mixed vaccine schedules. Despite the challenges of these urgent public health prioritisation studies an inspection by the MHRA inspection they reported no critical or major findings at LSTM.
Helen has actively contributed to the MHRA Risk Adaptive Approach as a member of the steering group to promote a more proportionate approach to the Regulatory Framework. This included publishing a model for Risk Adaptation in a pharmacokinetic clinical trial of neonates and infants then further blogs on the MHRA web site. Helen jointly presented this with the MHRA Inspectorate to the FDA and EMA. As requested by the Institute of Clinical Research Helen authored a chapter on paediatric consent for the Handbook of Clinical and Healthcare Research.
Helen obtained a PhD in Pharmacokinetics of Ciprofloxacin in Neonates and Infants with suspected Gram-Negative Sepsis with University of Liverpool Faculty of Medicine. This included conducting a pharmacokinetic clinical trial of sixty neonates and infants in critical care; a pharmacodynamic study comparing the outcome of neonates with confirmed Gram-negative sepsis compared to the Minimum Inhibitory Concentration (MIC) of Ciprofloxacin. The thesis included a study comparison of buccal with serum samples for DNA extraction.
Selected News and Media
Recognition by the NIHR Clinical Research Network – Research Response to the Pandemic 27th May 2021
BBC Radio Merseyside 14th April 2021 COVID-19 vaccine trial, COM COV II.
Granada Reports 8th March 2021 The Liverpool scientists at the forefront of the fight against Covid
Granada Reports 14th April 2021 Covid: 'Mix and match' vaccine trial at Liverpool School of Tropical Medicine expanded to include Moderna and Novavax
Granada Reports 11th February 2021 The Liverpool Scientists at the forefront of the fight against COVID
Liverpool Echo 24th July 2020 Leading the way with vaccine trials COVID -19
Liverpool Echo May 2020 End of the pandemic' in sight as 500 Mersey health staff test new coronavirus vaccine