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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

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