Table 4 Common concepts requested in the 23 protocol guidelines with explicit methodology or institutional adoption (numbers in parentheses represent number of guidelines)*
From: Guidelines for randomized clinical trial protocol content: a systematic review
Concepts in >75% guidelines | Â |
General | Statistical analysis |
  Rationale/purpose (20) |   Statistical/analysis methods (general) (21) |
  Objectives (general) (18) |  |
Concepts in 51-75% of guidelines | Â |
General | Recruitment and eligibility (continued) |
  Trial sites/institutions/ location (12) |   Sample size + sample size/power calculation (17) |
  Background (general) (14) | Treatments and allocation |
Design |   Treatment/interventions (general) (14) |
  Study design type/description (17) | Assessments |
Recruitment and eligibility |   Outcomes/ endpoints (list) (15) |
  Eligibility criteria (16) |  |
Concepts in 26-50% of guidelines | Â |
General | Statistical analysis |
  Protocol/study title (9) |   Interim analysis description/general methods (7) |
  Principal investigator - name and address (9) |   Trial termination criteria/stopping rules (6) |
  Protocol summary (6) | Safety and monitoring |
  Prior research (literature review) (10) |   Assessment of safety - general (7) |
  Summary of known potential risks/benefits (6) |   Safety monitoring/procedures for unscheduled  events (9) |
Design |   SAE reporting procedures (to sponsor and regulatory |
  Statistical hypotheses (8) |   authorities) (8) |
  Study schematic/flow-chart (for example, periods, duration) (6) |   Data monitoring committee (role, composition, independence) (7) |
  Source population/recruitment source (7) |   Data management/record keeping (general) (9) |
Recruitment and eligibility |   Methods to ensure data quality/integrity (for example, monitoring, validation) (7) |
  Recruitment methods/subject selection (11) | Ethical considerations |
  Information for patients and consent/methods (8) |   Ethics (general heading) (6) |
  Eligible concomitant therapies (6) |   IRB review/approval/responsible IRBs (7) |
  Subject drop-out criteria (7) | Dissemination |
  Justification for sample size calculation (6) |   Publication policy (general) (6) |
Treatments and allocation |   Disseminating results/publication plan (general) (7) |
  Description of treatment (10) or comparators (8) | Other |
  Treatment duration (8) |   Trial management (general - personnel and administration) (9) |
  Allocation/randomization methods (general) (10) |   Budget (6) |
  Degree of blind (for example, double, who)/blinding methods (8) |   References/cited literature (10) |
Assessments |   Appendices (general) (6) |
  General (variables and data collection) (10) |   Copy of all questionnaires and data forms (8) |
  Primary endpoint(s)(7), Secondary endpoint(s) (6) (list) |  |
  Methods of assessment/required tests (11) |  |
  Timing of outcome assessment (7) |  |
  Follow-up procedures (7) |  |
Concepts in ≤ 25% of guidelines (n = 333; subset provided below) |  |
General | Treatments and allocation (continued) |
  Site investigators/collaborators - names and addresses (4) |   Reasons for degree of blinding (3) |
  Sponsor - name and address (5) | Assessments |
  Registration plans/registration number (4) |   Assessment of compliance (5) |
  Protocol identifying number (5) |   Validity/reliability of collection/measurements (1) |
  Funding source (3) | Statistical analysis |
  Rationale with reference to a systematic review (3) |   Description of planned subgroup analyses (2) |
Recruitment and eligibility | Other |
  Target population (5) |   Participant security/confidentiality (5) |
  Justification for special (for example, vulnerable) pop. (5) |   Study timetable (calendar (date) of events) (5) |
  Specific eligibility criteria - for example, health status  (2), co-enrolment in trials (2) |   Target duration for trial as a whole (5) |
Treatments and allocation |   Approximate time to complete enrolment (5) |
  Treatment dosage (5), route of admin. (5), justification (5) |   Dummy tables (3) |
  Form and location of treatment code (5) |   Curriculum vitae of investigators (5) |
  Allocation concealment (3), Implementation of randomization (1) |   Incentive to investigators/staff (1), participants (2) |
|  |    Conflict of interest (1) |
|  |   Consumer involvement (who and roles) (1) |