Trial Duration Estimator
Estimates the total duration of a clinical trial based on enrollment parameters, required sample size, follow-up period, and expected dropout rate.
Formula
Step 1 — Adjusted Sample Size:
nadjusted = n / (1 − dropout_rate)
Step 2 — Enrollment Duration:
Tenrollment = nadjusted / enrollment_rate
Step 3 — Total Trial Duration:
Ttotal = Tstartup + Tenrollment + Tfollow-up + Tcloseout
Where all time units are in months.
Assumptions & References
- Enrollment rate is assumed to be constant throughout the enrollment period.
- Dropout is assumed to be uniformly distributed across participants; the sample size is inflated upfront to compensate.
- Follow-up begins for each participant immediately after enrollment and is added as a single block after the last participant is enrolled (conservative estimate).
- Startup covers site activation, IRB approval, and protocol finalization; closeout covers data lock and reporting.
- Formula based on standard clinical trial planning methodology: Friedman, Furberg & DeMets — Fundamentals of Clinical Trials, 5th ed.
- For multi-site trials, the effective enrollment rate should be the sum of all site-level rates.
- This estimator does not account for interim analyses, adaptive designs, or seasonal enrollment variation.