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. Author manuscript; available in PMC: 2018 Sep 1.
Published in final edited form as: Crit Rev Oncol Hematol. 2017 Jun 24;117:30–37. doi: 10.1016/j.critrevonc.2017.06.008

Table 4.

Protocol Elements

PROTOCOL
ELEMENT		 PURPOSE INFORMATION
PROVIDED		 AFFECTED
DESIGN ELEMENT
Background

  • Provides summary of previous work

  • Justifies trial

  • Rationale for outcome estimates (patient population)

  • Rationale for anticipated treatment effect(s)

  • Phase

  • Number of arms

  • Randomization

  • Blinding

  • Interim analysis

  • Sample size

  • Trial duration
Objectives/Endpoints Defines objectives and endpoints

  • Type of intervention response

  • Response time point

  • Phase

  • Number of arms

  • Randomization

  • Sample size (methodology)

  • Trial duration (timing of response)
Eligibility (includes both inclusion and exclusion criteria) Sets criteria required for legitimate patient enrollment Specific parameters that result in inclusion or exclusion of patients to the trial Sample size (due to outcome estimate, adherence, withdrawal, drop-out)
Protocol Intervention(s) Describes how treatment(s) are delivered Treatment

  • Mode

  • Dose

  • Frequency

  • Duration

  • Blinding

  • Sample size (adherence, withdrawal, dropout)

  • Trial duration
Patient Follow-up Schedule Describes how patients will be followed after treatment Follow-up

  • Frequency

  • Duration

  • Sample size (loss to follow-up)

  • Trial duration (follow-up duration)
Analysis Plan Describes how all aspects of the data will be presented and analyzed

  • Rationale for analysis plan

  • Definition of primary and secondary analyses

  • Description of handling of missing data

  • Description of sensitivity analyses