Thoughtful, detailed planning significantly improves the likelihood that the study budget addresses all foreseeable conditions for timely implementation, conduct, and analysis of the clinical trial (study). Using reasonable projections during study preparation avoids and/or reduces budget add-ons and study timeline modification(s). Sponsors anticipating add-on or “out of scope” costs may include these expenses as part of the initial budget to avoid delays resulting from budget modifications and approvals necessary for implementation of said modification(s).
FACTORS TO CONSIDER
Primary to budget design and development, the sponsor conducts a detailed evaluation for study budget optimization. Increased spending during the design, development, and preparation stages potentially saves money during conduct and analysis. Study budget and budget justification must be appropriate for the aims and timeline of the clinical trial.
Costs are associated with the following:
1. STUDY STARTUP: Protocol/study document development; Site identification, recruitment, and selection/site pre-qualification visits; Study site number estimation; Protocol feasibility assessment; SOP development; Contract/budget negotiation; Essential document acquisition and review; Facilities review; Vendor and manufacturing site selection; Draft document IRB review; Essential staff determination; Study supplies/product arrangement; Regulatory documentation management; Study binder distribution; and, other preparatory tasks.
Sponsor resources utilized during the protocol development phase to create a scientifically valid design/good research methodology and user-friendly CRFs may avoid pitfalls and delays during the conduct of the study.
The protocol feasibility assessment will identify whether a specific site will be able to successfully accrue subjects and complete the trial, evaluate personnel qualifications and regulatory knowledge, determine whether the potential site has a commitment to research, is experienced in research in the therapeutic field under review, and has adequate time, staff, equipment and ancillary support systems to support research activities (e.g. an existing research infrastructure). Identifying good study sites increases the likelihood of successful study completion and may reduce potential problems and associated timeline delays/increased costs. Sites may provide input about whether study enrollment and data collection processes are realistic.
SOP development is integral to quality and a successful study. SOPs may be created/revised in-house (requiring staff time), provided by outside parties (e.g. SOP templates from FDA website), or obtained through consultant services for a fee.
Consultation with the FDA during study design and development provides input. A well written and solid protocol may have fewer modifications and delays, avoiding budgets increases.
2. INITIATION/MONITORING: Database creation/management; Training; Site initiation and...