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Table 2 Resources where adaptive designs increase use

From: Practical guidance for planning resources required to support publicly-funded adaptive clinical trials

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
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