Resource required | Examples of reasons of additional resource |
---|---|
Trial manager time | More complex protocol development More time to create patient information sheets Complexity of design Amendments Additional or more frequent meetings Data cleaning co-ordination for interim analysis Increased site communication and training Additional user testing of updated systems Increased co-ordination (i.e. timing of drug supply) Regulatory interactions Contract negotiations |
Statistician time | Simulations of design operating characteristics Protocol development (Interim) SAP development Interim analysis Trial Steering Committee/Data Monitoring Committee Report preparation More complex final analyses Additional “unblinded” statistician Additional quality control statistician Specification of system needs, user testing of systems |
Data manager/programmer/information specialist time | Increased set-up resource to prepare for planned adaptations and to build more complex databases/randomisation systems Increased time for complexity of data management plan Data cleaning for interim analysis Database lock for interim analyses Database amendments due to adaptations |
Staff with specialist expertise (e.g. senior statisticians/methodologists/trial manager) | Complexity of design Expertise required in adaptive designs Understanding consequences of adaptations |
Intervention costs | Extended timelines, and costs for changes in drug manufacture due to an adaptation (e.g. dose changes) Intervention-related data collection costs |
Non-staff CTU costs | Training Additional meeting costs Regulatory agency fees for amendments Additional travel costs if on-site monitoring is needed License fees for specialist software |
Other | Increase in timelines for adaptive designs due to planned breaks in recruitment due to interim analyses (not in all cases) Increase in resource to handle uncertainty |