My pharmacovigilance PhD journey

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How the topic was conceived

I started working in clinical research in the UK in 2004, directly after finishing my BSc in Applied Biology. After several years of work I decided it was time to continue my education and I registered for a part-time MSc in Clinical Research at Cardiff University. In 2011 I commenced my final year project investigating adverse drug reactions related to warfarin in my place of work (Guy’s and St Thomas’ NHS Foundation Trust). My project was successful and I was awarded the ‘academic prize for best student’ and I received my MSc with distinction. My MSc project supervisor asked me if I had considered studying towards a PhD and I had to admit I had not. My supervisor is an expert in benefit-risk assessment and had recognised that patients were often excluded from benefit-risk assessment discussions; which were often completed by pharmaceutical companies and regulators. As I worked at a hospital with access to patients, he felt this project could be well suited to me. After a little discussion he persuaded me to continue on as a part-time PhD student.

Turning the topic into a PhD

My interests are around early phase clinical research, in particular advanced therapy clinical trials (cell and gene therapy). We have implemented a robust quality system based on the UK Medicines & Healthcare products Regulatory Agency (MHRA) Phase I accreditation guidelines to support this work (https://www.gov.uk/guidance/mhra-phase-i-accreditation-scheme) at Guy’s and St Thomas’, my place of work. The accreditation process has a particular emphasis on ensuring participant safety through robust risk management, while ensuring quality data is produced. A proactive approach to risk assessment in combination with a reactive approach to incidents is essential for adequate risk management. Benefit-risk assessment is one element of this work, and involving patients directly in benefit-risk assessment during drug development is becoming increasingly important. My own PhD research is investigating the patient’s perspective in this regard; the level of risk that an individual is willing to accept may be higher or lower than what may be expected by regulators or pharmaceutical companies, depending on the degree of benefit delivered by their medication.

It took nearly 18 months of work to develop this topic into a PhD project: developing a method to incorporate patients in the benefit-risk assessment of medicines. My project would investigate current work in this area and would hopefully result in a method by which patients could contribute.  After some research, I identified that the most effective method for me to complete the project was to break it down into three main stages. The first stage would involve a questionnaire study to regulators and pharmaceutical companies and another to patient advocacy groups as a scoping exercise and to identify the views of key stakeholders. The next stage would involve interviews with representatives from the pharmaceutical industry and regulators and also the patient groups to collect much richer data. The final stage would involve focus groups with patients of different indications, resulting in the publication of a defined model which could be used routinely.

Supervision, funding and how the PhD has helped my career

I met my supervisor while studying for my MSc in Clinical Research and I was lucky enough to be fully funded by my employer, Guys and St Thomas Hospital Trust, through their training and education directorate. Undertaking the PhD has given me valuable experience in undertaking my own research and has also helped me develop a writing career, something I have always aspired to.