Goals / Definition
Clinical safety data and rationale for Phase 2 dose selection.
Clinical Development Plan initiated.
(*Clinical Development Plan is initiated prior to the FIH gate review and is updated & reviewed during development through to the DTF gate review.
CRITERIA
SAMPLE CONTENT REQUIREMENT
GUIDELINES FOR LEVEL OF DETAIL NEEDED
AT EACH GATE
▪ Clinical
development
plan updated
a) Overview of planned clinical activities:
• Study phase, objectives / research rationale
• Duration of the studies, number of subjects, recruitment criteria (e.g.,.
study arms, patient cohorts, comparators for non-inferiority trials, power
calculations etc.)
• Dosing & dosing modeling strategies
• Detailed rationale for Phase 2 dose range, and target clinical exposures
• Toxicology and toxicokinetic results to support doses and dosing duration
in Phase 2
• Drug combination assessment & plan
• Toxicology plan to support Phase 3
b) Clinical partners, proposed target countries, and study sites (based on criteria including
clinical expertise, sustainability, site capacity, and disease incidence / epidemiology studies,
etc.)
c) Definition of clinical endpoints (primary & secondary), methodology (clinical endpoint
assays, data collection plan, statistical methods, etc.), adverse event reporting, stopping
rules, etc.
d) Monitoring, data management, and biostatistics strategies
e) Post-marketed product surveillance / Phase 4 trial strategy
f) Mass product administration considerations (e.g., trial design, safety requirements, etc.)
g) Off-label use considerations
h) Trial size considerations for diseases with limited incidence rates
i) Potential risks and mitigation strategies
j) Timelines and budgets for clinical development
▪ Detailed Phase 2 clinical plan with
timeline including supporting CMC
and tox plans
▪ High-level / draft plan for Phase 3
▪ Updated risk identification and
mitigation needed for all
subsequent phases of
development
▪ Plans should reflect approaches to
accelerate decision making (e.g.,
adaptive designs, real-time data
analysis of clinical trials etc.)
▪ Phase 2 plan is modified during
Phase 1 trial as Phase 1 data
become available
▪ Clinical development plan extends
beyond DTF to accommodate the
time needed to report Phase 3
results and also cover additional
plans for pediatric studies and
post-market surveillance
CLINICAL DEVELOPMENT PLAN UPDATED
