During an epi/pandemic of infectious disease (ID) high-stake public health and clinical management decisions are made often on the basis of little empirical evidence. Participant recruitment is a significant barrier to the conduct of epi/pandemic research.
This PhD research aims to provide high quality evidence on barriers and solutions to participant recruitment during ID epi/ pandemic. The experience of potential research participants, clinicians and regulators from UK recruitment sites of PREPARE (Platform for European Preparedness Against (RE-)Emerging Epidemics) observational and clinical trials will be assessed.
Findings will inform ethically appropriate and optimised recruitment in future epi/pandemic research.
The spread of IDs rank among the greatest threats to humans. Trends such as migration, travel and intensive farming enhance the likelihood of epi/pandemics occurring. While significant progress has been made in the public health response, this is in contrast to clinical research response where there has been little impact on developing evidence based clinical management strategies, and many interventions are unproven. WHO and ECDC evaluations on the 2009 influenza pandemic highlighted the need for research during future pandemics/epidemics.1,2
There are multiple barriers to conducting research during epidemics/pandemics including rapid set-up, and behavioural and ethical barriers to patient recruitment.
WHO EURO evaluation:
EDCD evaluations: http://ecdc.europa.eu/enhrealthtopics/pandemic_preparedness/pandemic_2009_
Research & methods
This work is linked to the FP7 PREPARE project ‘Platform for European Preparedness Against (RE-)Emerging Epidemics’ (2014-2019) on which both supervisors are co-applicants http://www.prepare-europe.eu/ . PREPARE includes 2 multi-centred European clinical influenza trials in hospitalised and community patients and a large observational study which will take place over the next three years. These studies are using different consent models, and participants will be recruited in primary and secondary care. Cardiff is one of a number of UK recruiting sites.
To assess the preferences and experience of potential research participants around participating in emergency ID research;
To validate findings with members of the public;
To seek stakeholder view (ethics board committee members and clinical trialists, clinicians) on the impact of these findings;
To produce evidence-based recommendations for policy makers, and researchers submitting ethics permissions applications to conduct epi/pandemic research.
This project will involve mixed methods to conduct a high quality survey of participants in epi/pandemic research. Potential research participants (patients or legal representatives) who have been approached to enrol in PREPARE studies at UK recruitment sites will be considered eligible for our study. We will purposively sample participants of PREPARE studies and non-participants. Approximately 20-30 interviews will be conducted in each of the three PREPARE studies to assess the views, experience and preferences of taking part (or not) in research. The interview topic guide will be focus on around the consent and enrolment of ID research trials during emergencies, and consent for use of clinical data and samples for research. Lay members and patient groups will contribute to the development to take into account the sensitive nature of the topic and settings. Interviews will be audio-recorded, transcribed, analysed thematically and a proportion of the data will be double coded. NVivo software will be used. If within the scope, this project may be extended to a second European country with a contrasting culture. A researcher (linked to PREPARE) would be appointed to conduct the interviews in the language of that country and translate documents as required. All analysis would take place in Cardiff. This qualitative work will inform the development of a survey data collection tool that will be used across PREPARE studies with larger numbers of patients. Survey methodology will be used to develop and validate the tool. It will be administered across the PREPARE studies, and possibly also across a number of different European sites. Survey findings will be presented to clinicians and regulators through strategic workshops to consider the impact of its findings and identify how they might influence policy on epi/pandemic research.
The results will be included in a report for the PREPARE project and will be made available to European researchers planning future pandemic/epidemic research in the UK, and policy makers.
Results will also be published in International peer-reviewed journals and presented at conferences. Results will be disseminated to key stakeholder groups.
All necessary approvals will be obtained prior to commencement.
CV and a covering letter should be sent in the first instance to [email protected]