【Clinical】What components should a study protocol include?

刊登日期:2019-11-08  |  點閱次數 : 507 次 

The following components are suggested to be covered in a study protocol:

  1. Study title
  2. Study rationale and Background
    1. (1) Name and description of the study drug, a summary of findings from nonclinical and relevant clinical studies
    2. (2) Background information of the disease, current standard of care, and the prognosis
    3. (3) Assessment of known/potential risks and benefits
    4. (4) Summarized literature that are relevant to the trial
  3. Study objectives and Study endpoints
  4. Study design
    A description of the study design should include:
    1. (1) Phase of the study
    2. (2) A description of the design to be conducted (e.g., randomized, double-blinded, placebo-controlled, parallel design) and study procedures with corresponding figures and charts
    3. (3) Primary efficacy endpoint and Secondary efficacy endpoints
    4. (4) Methods to be used to minimize bias (e.g., randomization and blinding procedures)
      *Note: It should be specified how study participants will be assigned to study groups, without compromising the blinding.
      Plans for the maintenance of appropriate blinding and measures to prevent unblinding for the study should also be discussed.
    5. (5) The dosage and administration of study drug and control drug. Provide a justification for the route of administration and dosing regimen of the study intervention and control product.
    6. (6) The time will take for each individual participant (Participant duration)
  5. Inclusion/Exclusion criteria
    *Note: A woman of childbearing potential is eligible to participate if she is not pregnant, not breastfeeding, and agrees to follow contraceptive guidance.
    Contraception requirements/guidance (e.g., methods and duration of contraception) should be specified in the protocol. In general, these women or subjects that cannot follow this contraceptive guidance should be excluded.
  6. Study intervention
    1. (1) Include dosage, route of administration, dosing interval, and personnel who provides the intervention. If it is a blind study design, specify how the blinding will be maintained. If applicable, the protocol should state the conditions under which a dose change will be made, particularly in regard to toxicity or special population
    2. (2) Study intervention compliance
  7. Concomitant therapy/medications
    1. (1) Concomitant therapy/medications permitted
    2. (2) Concomitant therapy/medications forbidden
  8. Temporary discontinuation study intervention / Permanent discontinuation/Withdrawal criteria
  9. Study assessment and procedure
    1. (1) Efficacy assessments
      1. Specification of the efficacy parameters
      2. List and describe all study procedures and evaluations to support the determination of efficacy, including methods and time frame to record and analyze the efficacy parameters
    2. (2) Safety assessments
      1. Specification of the safety parameters (e.g., physical examination, vital signs, electrocardiograms, radiographic assessments, laboratory testing, assessment of adverse events)
      2. List and describe all study procedures and evaluations to support the safety, including methods and time frame to record and analyze the safety parameters
    3. (3) Adverse events and Serious adverse events
      1. Definition of Adverse events (AE) and Serious adverse events (SAE). All AEs will be assessed and classified using a protocol defined grading system (including standards of severity grading and relationship to study intervention). Specify time period for evaluation and frequency for event assessment and follow-up.
      2. Principles of safety reporting
  10. Statistics
    1. (1) Primary hypothesis, specifying the type of comparison (e.g., superiority, non-inferiority, equivalence) or others (e.g., descriptive)
      *Note: If it is a non-inferiority/equivalence design, provide a reasonable judgment for the margin selected.
    2. (2) Sample size determination with rationale
    3. (3) Analysis sets for efficacy and safety
      Intention-to-treat (ITT) Analysis Dataset, Per-Protocol Analysis Dataset, Safety Analysis Dataset
    4. (4) Method of statistical analysis for the primary efficacy endpoint and the secondary endpoints
    5. (5) Method of handling missing values
    6. (6) Planned interim analyses (if any). Describe the types of statistical interim analyses and stopping criteria (if any) that are proposed, including their timing and rationality.
    7. (7) If multiplicity is present, the method of controlling Type I error should be specified.
  11. Study flow chart; Schedule of activities



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