Routinely collected medical data- Use in clinical trials
Date: September 24, 2010
Venue: Royal Institute of British
Architects
Summary
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:
- 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.
- 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.
- 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:
Record
Linkage in Clinical Trials
Potential for Linkage in Trials in England
Data linkage in
Wales
Record Linkage in Scotland
NHS "e-Labs"
Use of National Cancer Data Registry
Using routine medical data in a cardiovascular safety trial
ePCRN to TRANSFoRm
Using
routine data in large-scale trials