RCT Evaluation Criteria and Headings
A randomized controlled trial (RCT) is an experiment in which investigators randomly assign eligible human research participants or other units of study (e.g., classrooms, clinics, playgrounds) into groups to receive or not receive one or more interventions that are being compared. The results are analyzed by comparing outcomes in the groups.
Please refer to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS-2), Chapter 11 for important information including key requirements and recommendations for conducting trials.
Of note, irrespective of the suggested peer review committee, evaluation of all applications containing an RCT as a major component will need to consider the specific RCT evaluation criteria below. In addition, such applications containing an RCT as a major component must also be structured according to the specific headings below.
Applications considered to contain RCT as a major component include:
- Applications exclusively containing an RCT (or multiple RCTs)
- Studies including multiple aims where the main focus is an RCT (such as a combination of development or pre-clinical work, with a trial or a trial, with some follow-up work)
- Any application where the majority of the budget resources are directed towards an RCT component
Applications not considered to contain RCT as a major component include:
- Applications with multiple aims, with a small RCT being only one of those aims
- Studies where the possibility of a small RCT is discussed, but is centered around animal-work
- Studies where no randomization is occurring (participants may have been previously randomized, but no new randomization is being done in the context of the work proposed)
- Studies about RCTs, but that do not contain an RCT component (e.g. translational work following a completed RCT)
- Systematic reviews of RCTs which do not include an RCT component
- Any non-randomized clinical trial
The peer review committees will take into account the following key questions when assessing each section of the application containing an RCT as a major component.
Section 1 - The need for a trial
Has the importance of the issue been adequately explained in terms of:
- Present and future resource implications for Canadian healthcare and the economy in general.
- Are the hypotheses to be tested and/or the study objectives specified and described clearly?
- Is the trial addressing the right question(s)?
- Is this the right time to conduct the trial with respect to current knowledge of the intervention and current use of existing technologies?
- Are the reasons for the study and the changes that might be implemented as a result of the study adequately explained?
- What evidence is available to inform the need for and design of this trial (e.g.: systematic reviews)?
- Is the proposed research compatible with the extent of the available knowledge, nationally and internationally?
- What impact will the results have on practice or our understanding of the proposed intervention or underlying condition?
- Will the results of the trial be generalizable beyond the immediate research setting of the trial in a way that will maximize the impact of the results?
Section 2 - The proposed trial
- Is the study design appropriate to answer the research questions posed?
- Has sufficient account been taken within the study design of the issues of generalizability and representativeness?
- What is the justification for the hypothesis underlying the power calculations?
- Are the outcomes, and their measures, clearly described and appropriate to the scientific hypothesis?
- Has the trial population been defined adequately in relation to the target population so that the results will have meaning?
- Have the measures been validated specifically for the target population(s)?
- Is the control group appropriate?
- How will sources of bias be avoided or taken account of?
Section 3 - Trial management
- Does the proposed team of investigators have the necessary range of disciplines and experience necessary to carry out the study?
- Does the trial team include people with experience in successfully running large multi-center trials?
- Has adequate statistical advice been sought and incorporated?
- Has adequate advice been sought and incorporated on other health services research issues if they are to be addressed?
- How will the trial be coordinated?
- What are the roles of members of the trial team?
Other Important Issues
CIHR does not require that health economic measures be included as outcomes in all its trials. However, it does require a clear and informed justification of why these measures are to be either included or excluded.
Quality of Life
CIHR does not require that quality of life measures be included as outcomes in all its trials. However, it does require a clear and informed justification of why these measures are to be either included or excluded.
Consumer Involvement in Trial Development
CIHR encourages the involvement of consumers and patient advocate groups with the aim of better trial design and greater acceptability of both trials and its findings.
Biological samples for future genetic analysis
The potential value of RCTs as a source of well-characterized samples for future genetic analysis is being increasingly recognized and proposals for collection of this type of sample within a trial are welcomed. However, applicants should carefully consider the balance between the potential value of the samples and the impact on recruitment and logistics of the trial.
Please discuss the nature of and need for international collaboration.
Patient Information Sheet
A draft patient information sheet and consent form should be appended.
If relevant, discuss the involvement of any proposed partner(s).
Irrespective of the suggested peer review committee, all applications containing an RCT as a major component must be structured according to the headings provided below.
Applications should include only the main headings by title, while the subheadings may be referred to only by number.
An entry is required under every heading and subheading.
Please note that failure to comply with these requirements can negatively impact the evaluation of your application.
1. The Need for a Trial
1.1 What is the problem to be addressed?
1.2 What is/are the principal research question(s) to be addressed?
1.3 Why is a trial needed now? E.g. Provide evidence from the literature. Furthermore, give references to any relevant systematic review(s)1 and discuss the need for your trial in the light of the(se) review(s). If you believe that no relevant previous trials have been done, give details of your search strategy for existing trials.
1.4 How will the results of this trial be used? (E.g. contribute to knowledge translation, such as improving understanding, informing decision making and treatment guidelines, etc.)
1.5 Are there any risks to the safety of participants involved in the trial? Please describe.
2. The Proposed Trial
2.1 What is the proposed trial design? E.g. Open-label, double or single blinded, etc.
2.2 What are the planned trial interventions? Both experimental and control.
2.3 What are the proposed practical arrangements for allocating participants to trial groups? E.g. Randomization method. If stratification or minimization are to be used, give reasons and factors to be included.
2.4 What are the proposed methods for protecting against sources of bias? E.g. Blinding or masking. If blinding is not possible please explain why and give details of alternative methods proposed, or implications for interpretation of the trial's results.
2.5 What are the planned inclusion/exclusion criteria?
2.6 What is the proposed duration of treatment period?
2.7 What is the proposed frequency and duration of follow up?
2.8 What are the proposed primary and secondary outcome measures?
2.9 How will the outcome measures be measured at follow up?
2.10 What is the proposed sample size and what is the justification for the assumptions underlying the power calculations? Include both control and treatment groups, a brief description of the power calculations detailing the outcome measures on which these have been based, and give event rates, means and medians etc. as appropriate.
(N.B. It is important to give the justification for the size of the difference that the trial is powered to detect. Does the sample size calculation take into account the anticipated rates of non-compliance and loss to follow-up given below?)
2.11 If applicable, are health service research issues be addressed? Justify inclusion/exclusion of health economics and quality of life measures. If these measures are to be included full details should be given including power calculations.
2.12 What is the planned recruitment rate? How will the recruitment be organized? Over what time period will recruitment take place? What evidence is there that the planned recruitment rate is achievable?
2.13 Are there likely to be any problems with compliance? On what evidence are the compliance figures based?
2.14 What is the likely rate of loss to follow up? On what evidence is the loss to follow-up rate based?
2.15 How many centers will be involved?
2.16 What is the proposed type of analyses?
2.17 What is the proposed frequency of analyses?
2.18 Are there any planned subgroup analyses?
2.19 Has any pilot study been carried out using this design?
3. Trial Management
3.1 What are the arrangements for day to day management of the trial? E.g. Randomization, data handling, and who will be responsible for coordination.
3.2 What will be the role of each principal applicant and co-applicant proposed?
3.3 Describe the trial steering committee and if relevant the data safety and monitoring committee.
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- Footnote 1
For definition of a systematic review, see Oxman AD. Checklist for review articles. Bmj 1994; 309:648-51.
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