My journey to a pharmacovigilance PhD

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How the topic was conceived

My pharmacovigilance-related PhD happened because of an observation that leant itself to this field. I worked in clinical trials, and began to wonder if conversations staff had with participants to collect adverse events influenced trial results. Theoretically a questioning method could impact drug labeling. Moreover, if trials use different questioning methods this could impede meta-analyses necessary to enhance detection of adverse drug reactions. I reflected on personal experiences I had as a community pharmacist where it was not unusual to ask someone if they had health problems or were taking a medicine and them answer ‘no’, then later reveal treatment for an underlying condition. It wasn’t always they forgot – they often expressed a response like “no I don’t take any medicines ….. just my asthma pump/blood pressure tablets”. So the health issue/medicine seemed perceived in a way that influenced the report. When I mused this now with friends and colleagues, other anecdotes emerged – like the mother who had several health issues but didn’t want to bother her GP so mentally selected a subset to mention.

Turning the topic into a PhD

I hypothesized there could be similar problems in research, where there is a significant reliance on information where the participant is the only source. My first idea was to nest an investigation into our antimalarial-antiretroviral drug interaction trial, and a similar one by collaborators in another country as comparison. We asked participants about their health and use of medicines through different questioning techniques, then interviewed them to uncover why some reported differentially.[1] To complement this I wanted to explore the range of questioning methods used in antimalarial trials (and why a particular method was chosen), and, aside from malaria, whether others had compared elicitation techniques. These questions leant themselves to a survey and Cochrane review.[2] [3] The last aspect was chosen largely for convenience. I was working on a World Health Organisation pregnancy registry, and had the opportunity to investigate if pregnant women had similar or different experiences to the trial populations as regards reporting.[4] So ultimately my thesis was concerned with understanding the conversations we have with research participants about their health and medicine use, and considering if there is room for improvement, and harmonisation, of these interactions within or between studies.

Supervision, funding and how the PhD has helped my career

Working in academia is advantageous for pursuing further education. My manager was happy to be my primary supervisor as the topic fitted our group’s interests. The questions I was asking, however, required a blend of pharmacoepidemiology, social science and anthropology, and I didn’t have grounding in the latter two. So I had to organise training and find co-supervisors in those fields - I searched my institution’s hand book and found part-time semester courses, and senior collaborators from two other institutions with those skills agreed to the role. This was pivotal to achieving the degree, as was my primary supervisor being instrumental in mentoring me to think through relevance of the findings to clinical trial safety data.

I think my experience shows that those working in a research support role can move into academia, but it is important to think deeply to identify a topic that really interests you and is relevant enough to the employer to support. I was fortunate the experimental work was costed within our grants and I qualified for a 75% staff fee reduction. The research conduct and paper writing could be done in work time, with most of the thinking (one does become obsessed) and thesis writing in my own time. So balancing a full time job with overseas travel, a young family and the PhD was challenging; it took me 5 years part-time. However, thanks to the participants, supervisors, colleagues and funders I end up interested in a niche topic with additional research skills, and plans to pursue this in future collaborative academic work.