Interventional
- Randomise Into Database Epidemiology
- Genetic studies
- Prospective data collections
R
andomise Into Database Epidemiology
Combine the power of standard computerised data collection with key aspects of clinical trial methodology in order to conduct highly cost-effective randomised studies of treatments in everyday normal care. After randomisation, the relevant clinical data is collected through the GPRD database.
Observational data used in classic case control or cohort studies is the most often used methodology for ascertaining safety and effectiveness of medicines. Such studies can however suffer because of residual confounding whereby there are factors that cannot be controlled for in the analysis. New products are particularly prone to such confounding as they are subject to channelling into certain types of patients- those in whom the prior drug lacked effectiveness, the disease has progressed or who had drug intolerance. As a consequence any non-randomised comparison between old and new is subject to confounding and may not give a fair or true comparison.
- Recruitment of very large numbers possible
- High quality recording ensured
- Sheer simplicity
- Rapid start up
- Highly cost effective
- Regulatory requirements enabled
Genetic studies
Large sample sizes possible
Intermediate data can be collected
Linkage with data of known high quality
GPRD has over 300 practices, with access to over 2 million patients that are willing to collect blood or other samples suitable for genetic research. The samples would be provided against a unique study identifier as would the associated longitudinal phenotypic data. The quality and validity of GPRD data has been extensively documented as is required for such research. Additional data can also be collected at the time the sample is taken.
Prospective data collection
Patient recorded outcomes and diaries
Quality of life measures
Additional GP/nurse data collections
The GPRD relationship with its GP partners is such that we can arrange to collect data additional to that collected in normal everyday care and or data specifically from patients. This is a tailored service and can be conducted using electronic collection, paper or diaries.
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