Objectives
Measure the cost-effectiveness of disease modifying therapies (DMTs) in slowing the rate of progression of patients in relapsing–remitting MS (RRMS), or in secondary-progressive MS (SPMS) characterised by relapses as the dominant cause of increasing disability. Monitor their progression using the expanded disability status scale (EDSS); Compare their rates of progression with those of patients in a ‘natural history’ cohort; calculate the cost-effectiveness of the DMTs using a model developed by ScHARR for the Department of Health Routine data collection on this cohort will continue for at least 10 years.
Scope
5,200 patients in 70 sites in the UK addressing PM; On-Site Monitoring; Data Management; Data Entry; PACE DM- EDC and iVAL; PACE Biostatistics & Programming
Challenges
This was a ‘Rescue’ study, inherited from an academic contractor. Study had been running for 3 years and data already collected which was yet to be quality-controlled. The database being utilised was not suitable for clinical data. Sites were not being paid for their participation in the Scheme, therefore motivation and resource issues were a consideration.
Solutions
- All data re-entered into a validated database
- Monitors specially trained to provide additional support to sites in addition to standard quality control checks
- PAREXEL provided an in depth understanding of sponsor objectives and current issues, and flexible data management and site management solutions
Outcome
Study running to planned timelines with significant improvements in quality of data and support to sites.