Unconsented linkage between dormant trials and administrative data: practical and regulatory implications

Main Article Content

Maximiliane Verfuerden
Mary Fewtrell
Kathy Kennedy
Alan Lucas
John Jerrim
Katie Harron
Ruth Gilbert


Half of all infants are fed formula milk. However, attrition biases evidence on the long-term safety of formula ingredients. We used unconsented linkage between administrative education and health records of young people who were randomised as infants to formula milks, to determine long-term safety and efficacy.

Objectives and Approach
We used record level data from a series of 9 historical randomised controlled trials (RCTs) conducted in 1982-2002 (n=3,500 participants), which are key to the evidence-base around formula-composition. All later follow-ups are biased by attrition leading to limited evidence around the long-term effects of formula ingredients on cognition and metabolic and cardiovascular health. We sought permissions from data providers and regulatory agencies for unconsented linkage to education and hospital records, as proxy measures for cognitive and health development. We discuss the steps that were implemented to safeguard the participants' privacy and achieve ethical and multi-institutional approval for this project.

Achieving provisional ethical approval took 41 days. Achieving agreement in principle to match trial data to individual level education records took 4 months and 2 weeks, while agreement to match trial data to individual level hospital records is still underway (5.5 months in February 2018). Delays in institutional approval were largely due to unharmonised data security certificates between the two government departments holding the health and education records. Digitising and cleaning all handwritten RCT participant identifiers prior to linkage took 9 months of full-time researcher time. Maintaining separation of identifiers and attribute data required specific secure haven provision. Results on the success of linkage between RCTs and education records will be presented at the conference.

While directly contributing to the evidence around infant-formula-composition, this project will also act as a proof-of-concept study. Unconsented linkage between dormant RCTs and administrative data could be a novel and cost-effective method to generate evidence on the long-term efficacy and safety of interventions.


Linked data are increasingly used in pharmacoepidemiology studies to enhance value beyond that which can be achieve from stand-alone pharmaceutical data. The complexity of pharmaceutical data can make any linked data analysis challenging and it is imperative that this is matched by the human capacity to perform this work.

Objectives and Approach

Research is needed to understand the state of the current pharmacoepidemiology workforce and to prioritise its capacity building needs. We aim to profile the Australian pharmacoepidemiology workforce to explore views, needs, priority areas and perspectives relevant to capacity building. Participants are the regular pharmacoepidemiology workforce (Group 1) and senior medicines stakeholders (Group 2). Following a literature review and consultation with a group of key informants, we developed survey and interview instruments for each group. We piloted the instruments in February 2018 and study data collection is planned for March 2018. We will use a mixed-methods approach to analyse the data.


We conducted a review of existing literature and identified workforce views, needs and priorities at four levels: personal, team, organisation and wider community. During the consultative process, the informants highlighted the multidisciplinary nature of the pharmacoepidemiology workforce including many with non-health related backgrounds. They also raised concerns about attracting applicants with suitable skills and experience, job satisfaction, career progression and workforce retention. We developed instruments to (i) further explore these issues, (ii) ascertain their experience with linked health data, (iii) determine their training needs, and, (iv) learn about their future intentions. We will present findings on issues pertinent to the Australian pharmacoepidemiology landscape and suggest priorities for building workforce capacity.


This study will provide empirical evidence to support and prioritise capacity building in the Australian pharmacoepidemiology workforce to improve their ability to work with linked data. The instruments that we developed and findings may be relevant to phamacoepidemiology workforce in other countries and other emerging fields that use linked data.

Article Details

How to Cite
Verfuerden, M., Fewtrell, M., Kennedy, K., Lucas, A., Jerrim, J., Harron, K. and Gilbert, R. (2018) “Unconsented linkage between dormant trials and administrative data: practical and regulatory implications”, International Journal of Population Data Science, 3(4). doi: 10.23889/ijpds.v3i4.731.

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