Change to Competition Deadline Schedule for Randomized Controlled Trials Program
In light of budget limitations and in recognition of the number of full applications expected for submission to the RCT program during 2006-2007, CIHR has taken the operational decision to hold only 2 competitions for full applications to the RCT Program in 2006-2007. Full applications will only be accepted for the September 1, 2006 (Registration deadline: August 1, 2006) and February 15, 2007 (Registration deadline: January 15, 2007 ) competitions.
To ensure that high quality applications continue to be developed for funding as Full applications in future years, RCT Outline applications will continue to be accepted at the usual deadline dates of August 1, 2006; October 1, 2006; January 15, 2007 and March 1, 2007.
For more information, please consult the Funding News and Developments section.
A randomized controlled trial (RCT) is an experiment in which investigators randomly assign eligible subjects (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 analysed by comparing outcomes in the groups. CIHR recognizes the importance of randomized controlled trials as a tool to provide high quality evidence on the efficacy and effectiveness of interventions in health. This includes, but is not limited to the following types of interventions: Behavioral, Knowledge Translation, Complementary and Alternative Healthcare, Devices, Diagnostic, Educational, Health Services, Lifestyle, Medical Management Strategies, Pharmaceutical, Population Health, Preventative, Psychosocial, Surgical, Other therapeutic procedures. It also recognizes the complexity of designing, co-ordinating and monitoring trials and the importance of incorporating their results into practice. The CIHR Randomized Controlled Trials procedures are aimed at ensuring that public money is spent on well-managed trials of only the highest scientific quality, are safe for participants and are ethically sound. The procedures are designed to help those involved in the design and management of trials and to assist those who are involved in deciding which trials should be funded through the peer review process. Detailed instructions can be found here.
The guidelines and procedures for application to the Randomized Controlled Trials Program have been tailored to examine two sets of questions:
1. Is there a real need for the trial?
2. Is the study team, design, methodology and trial management robust?
Table 1 RCT Outline
| RCT Outline | |
| Deadline Dates | Aug 1 Oct 1 Jan 15 Mar 1 |
| Research Module | Routing slip, page 1, page 2a, page 3, pages 5-7, page 9, page 11(a,b) if applicable, page 12 (Research proposal numbered page 12a-12m. Use headings for RCT Outline). Appendices are not permitted. |
| Applicant consent form | Nominated Principal Applicant to complete and sign |
| Signature Page of Research Module (Page 2a) |
|
| CV Module |
Draft versions of the CV modules will NOT be accepted. It is the responsibility of the Nominated Principal Investigator to ensure that all CV modules submitted with the application are the validated versions |
| Operating Budget Module | For industry-partnered RCTs ONLY. |
| Industrial Partnership Module | For industry-partnered RCTs ONLY. |
| Number of copies Required | original and 8 copies (of each module) or original and 9 copies for industry-partnered RCTs. |
An RCT Outline is a letter of intent which is peer reviewed by the Randomized Controlled Trials committee. The results of the review assist CIHR and the applicants in identifying those ideas that are likely to be competitive, and to provide constructive feedback for a Full Application or subsequent proposals. Studies that are recommended to proceed to a Full Application are not, of course, guaranteed eventual support.
First-time applicants to the Randomized Controlled Trials program or applicants who have never held a CIHR RCT Program grant as Principal Investigator must submit an RCT Outline. Principal Applicants who have held, or hold an RCT or Clinical Trial grant are not required to submit an RCT Outline, although it is encouraged.
Submission of an RCT Outline is also required for all Randomized Controlled Trials in which the total budget is $2 million or greater, AND/OR the annual budget is $500,000 or more, AND/OR the duration is greater than 5 years AND/OR international collaboration is proposed OR an industry-partnered application is proposed. Full Applications for industry-partnered projects OR projects fulfilling any of the above-mentioned conditions will be accepted only if they have been successful at the RCT Outline stage.
The RCT Outline submission utilizes the standard CIHR application modules with specialized instructions for their completion (see Table 1).
RCT Outlines must be submitted by the deadlines given in Table 1. Results will be available approximately 5 months later. Decisions will be announced officially about one month after that. Thus, the earliest possible date for applicants with successful RCT Outlines to register their intent to submit a Full Application is approximately 6 months following the submission of the RCT Outline. The latest date to register their intent to submit a Full Application is one year from the notification of a successful RCT Outline. The usual Full Application deadlines would then apply.
Please structure your RCT Outline using the headings provided below. This enables the applicant to provide the information required for peer review. Make an entry under every heading. Failure to use the headings will result in the administrative withdrawal of your Outline 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? Evidence from the literature - see 1.4 below, professional and consumer consensus and pilot studies should be cited if available.
1.4 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.
1.5 How will the results of this trial be used? E.g. Inform decision-making/improve understanding.
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 minimisation are to be used, give reasons and factors to be included.
2.4 What are the proposed methods for protecting against other 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 trials 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? 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. What is the justification for the size of 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; see sections 2.12 and 2.13?
2.11 What is the planned recruitment rate? How will recruitment be organised? Over what time period will recruitment take place? What evidence is there that the planned recruitment rate is achievable?
2.12 Are there likely to be any problems with compliance? On what evidence are the compliance figures based?
2.13 What is the likely rate of loss to follow-up? On what evidence is the loss to follow-up rate based?
2.14 Give details of the planned analyses.
2.15 Are there any planned subgroup analyses?
2.16 What is the proposed frequency of analyses? (Including any interim analyses.)
2.17 Will the trial address any economic issues? (This is not a requirement. However, please justify the inclusion/exclusion of any health economic studies and give details of any study proposed.)
2.18 What is the estimated cost and duration of the trial?
3. DETAILS OF TRIAL TEAM
3.1 Trial management. Briefly describe the role of each applicant proposed. Please indicate whether a Data Safety and Monitoring Committee will be established and describe its composition.
3.2 International Collaboration (if applicable). Please discuss the nature of and need for any international collaboration.
3.3 Participating centres. Please list the proposed participating centres.
4. OTHER FUNDING SOURCES
Provide name(s) and dollar figure(s) for funding being sought from other potential funders, including industry.
If you have any questions, please contact:
Canadian Institutes of Health Research
Room 97, 160 Elgin Street
Address Locator 4809A
Ottawa ON K1A 0W9
Tel: (613) 957-6137, E-mail: ichikuru@cihr-irsc.gc.ca, or
Tel: (613) 941-0718, E-mail: ischweitzer@cihr-irsc.gc.ca, or
Tel: (613) 957-8668, E-mail: gvallee@cihr-irsc.gc.ca, or
Tel: (613) 941-4438, E-mail: tgasparini@cihr-irsc.gc.ca
Fax: (613) 954-1800
Table 2 Full Application
| Registration for a Full Application | Full Application | |
| Deadline Dates | Aug 1 Oct 1 Jan 15 Mar 1 |
Sept 1 Nov 1 Feb 15 Apr 1 |
| Research Module | Routing slip, pages 1, 2a, 3, 5-7, 9 |
Routing slip, page 1(all signatures required), pages 2a, 3-7, page 9, pages 10 &11(a,b) if applicable, page 12(Research proposal numbered 12a-12m. Use headings for Full Application), research proposal appendices (35 page maximum). Research module Appendix 1, 2 & 2a, as needed. |
| Applicant consent form | Nominated Principal Applicant to complete and sign | Nominated Principal Applicant to complete and sign |
| Signature Page of Research Module (Page 2a) |
|
Original signatures from Nominated Principal Applicant and any other Principal Applicants and Co-Applicants. |
| CV Module |
|
Full CV Module for Nominated Principal Applicant and any other Principal Applicants and Co-Applicants, properly signed by each. Draft versions of the CV modules will NOT be accepted. It is the responsibility of the Nominated Principal Investigator to ensure that all CV modules submitted with the application are the validated versions |
| Operating Budget Module | N/A | All Pages. |
| Industrial Partnership Module | N/A | Full Industrial Partnership Module with proper signatures. |
| Number of copies Required | 1 original and 2 copies (of each module). | 1 original and 8 copies of each module (9 copies for industry-partnered applications). |
Please structure your Full Application using the headings provided below. Make an entry under every heading. Failure to use the headings will result in the administrative withdrawal of your full 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? Evidence from the literature - see 1.4 below, professional and consumer consensus and pilot studies should be cited if available.
1.4 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.
1.5 How will the results of this trial be used? E.g. Inform decision making/improve understanding.
1.6 Describe any risks to the safety of participants involved in the trial.
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 Will 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.
2.11 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?
2.12 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 centres 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.
If you have any questions, please contact:
Canadian Institutes of Health Research
Room 97, 160 Elgin Street
Address Locator 4809A
Ottawa ON K1A 0W9
Tel: (613) 957-6137, E-mail: ichikuru@cihr-irsc.gc.ca, or
Tel: (613) 941-0718, E-mail: ischweitzer@cihr-irsc.gc.ca, or
Tel: (613) 957-8668, E-mail: gvallee@cihr-irsc.gc.ca, or
Tel: (613) 941-4438, E-mail: tgasparini@cihr-irsc.gc.ca
Fax: (613) 954-1800
1 For definition of a systematic review, see Oxman AD. Checklist for review articles. BMJ 1994; 309:648-51.
