Information for Investigators - How much will my trial cost?

How much will my trial cost?

Every trial is different and we work with investigators to understand what each trial will require so that appropriate funding applications can be submitted.   Factors that will influence cost  are:

• Type of study – CTIMP, non CTIMP, device trial
• Duration of each stage of the trial – set-up, recruiting, patient treatment, patient follow-up, data analysis and reporting.
• Number of patients/participants
• Number of study sites and types (e.g. PICs and treatment centres, hub and spoke models, locations and countries)
• Number of products to be sourced and/or coordinated (e.g. study drugs/IMPs, contrast agents, blood or biopsy sample packs)
• Screening and eligibility requirements e.g. simple one stage entry vs two stage recruitment where initial screening tests are required to confirm eligibility for a main study.
• Complexity of the design (e.g. single cohort receiving the same intervention vs multi arm multi stage dose escalation then expansion)
• Phase of trial (e.g. a First In Human study with a new product vs a phase 2 using a well-established and well-documented IMP).
• Number of biological samples per patient to be collected, shipped and tracked
• Volume and frequency of data to be collected per patient, schedule for data cleaning and reporting (e.g. single final report vs frequent dose escalation decisions or requiring interim analyses)
• Number of data sources and types (e.g. CRF data, laboratory, imaging, routine NHS data)
• Number of third parties to be managed: e.g. laboratories, IMP suppliers (manufacturer/packaging/labelling/QP/distribution)
• Stakeholder and reporting requirements
• Data management and monitoring requirements (based on risk assessment)
• Relationship with IMP providers – what reporting do they need and when (e.g. SAEs, SUSARs, DSURs)
• What interim reporting or analyses may be required by the design, funders or stakeholders.
• Source(s) of funding (with pricing as per Oxford University policies)