Routine Medical Data in Clinical Trials

Routinely collected medical data - Use in clinical trials

  • Date: September 24, 2010
  • Venue: Royal Institute of British Architects


Medical records are increasingly becoming computerised and are potentially available for use in clinical trials. Over the next ten years there is likely to be a significant expansion in the use of such data in trials, both in the UK and internationally. This also provides the opportunity to conduct new types of low-budget trials that would otherwise not be feasible; both to study the safety and effectiveness of new interventions and to look at comparative effectiveness or comparative safety of commonly used but understudied treatments.

Workshop participants were provided with an overview of the opportunities available to use routinely collected medical data to aid in the design of, feasibility assessment for and conduct of clinical trials. In particular, participants:

  1. Became aware of opportunities in England, Scotland and Wales to access routinely collected medical data in support of clinical trials, including descriptions of current data sources, procedures for gaining approval to access data and strengths and limitations of existing datasets. They also learned about ongoing developments and their timeframe for implementation.
  2. Learned from trialists about their experiences in gaining permission for access and using routine data from primary care, secondary care and mortality registers in ongoing and completed trials. This included the use of data for study design, pre-screening for potentially eligible patients, baseline history, follow-up of prescriptions and study outcomes during the trial and for long-term follow-up beyond the end of the randomised component of a trial.
  3. Discussed unresolved methodological and practical problems when using routine health data in trials. These included quality issues around coding variability, and missing events.

Click on the links below to view the workshop presentations: