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Trial conduct methodology
Trial conduct methodology
Much current clinical trials methodology
(including some activities deemed necessary to fulfil regulatory
and Good Clinical Practice [GCP] requirements), is not based on
good evidence.
Therefore, in trial conduct methodology, we
aim to improve the quality, reliability, timeliness and
cost-effectiveness of trials through research into key aspects of
trial conduct, an area where very little prospective work has
previously been done.
Areas of trial conduct in need of research
Pre-accrual
- Optimising patient and public awareness and engagement
- Quality of informed consent; impact on patient accrual and
retention
- Site selection and training
- Protocol, CRF & database design
During accrual
- Monitoring and improving protocol compliance and data quality
and completeness
- Maximising retention of patients on treatment
Post-accrual
- Patient retention during follow-up
- Use of routinely-collected data for follow-up and outcome
assessment
- Presentation, publication and dissemination of results
Current research focus
activities
Attrition in randomised
controlled trials
Trial monitoring
Risk-adapted approaches to the management of clinical
trials
