請解釋何謂隨機對照試驗(流行病學)?

請告訴我何謂randomized control trial, RCT 隨機對照實驗

RCT的定義及這樣的實驗設計的使用時機是什麼?

RCT的特色(優缺點)是什麼?

連結網站也可以,不要給我垃圾喔!

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  • j0426k
    Lv 6
    2 decades ago
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    Randomized Controlled Trials

    Description

    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. Applications will be examined for the relevance of the question posed, and the appropriateness of the methodology and of gender representation in the study design and selection of research subjects.

    Applications for dose finding studies, safety and efficacy studies and other non-randomized clinical studies must be made through the CIHR Operating Grants Program, and will be reviewed by the relevant content committee. (Please refer to the Partnerships Programs guidelines for those applications funded in part by Industrial Partners.) CIHR will not provide support for studies that are solely for the purpose of satisfying regulatory requirements.

    There are 4 competitions a year for this program with application deadlines for Full Applications of: September 1, November 1, February 15, and April 1. More information can be found in the detailed instructions

    Notes about CIHR deadlines

    Deadline dates indicate the latest acceptable date for a courier-stamped application.

    If the deadline date falls during a weekend or a holiday, the deadline will be the next working day.

    RCT Outline

    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. Renewal applications do not require a prior RCT Outline submission

    However, submission of an RCT Outline is 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.

    Full Application

    Applicants whose RCT Outline was recommended to proceed to a Full Application must register their intent to apply. Applicants must also register their intent to apply for all new or renewal Randomized Controlled Trial Grants. In both cases, registration must be made one month before the deadline date for the Full Application.

    Submission of Full Applications utilizes the standard CIHR application forms with specialized guidelines for the completion of the Research module. Guidelines and forms are available elsewhere on CIHR's website.

    CIHR will consider the provision of funds for feasibility testing, pilot projects, the expenses of monitoring committees and, when specially justified, for the coordination of major multi-centre trials

    CIHR will allow funds to be used to support non-Canadian centres when the trial is clearly a Canadian initiative and the majority of centres are located in Canada. In such cases, the applicants must justify the inclusion of foreign sites within the context of a RCT Outline application prior to the submission of a Full Application.

    Within the Randomized Controlled Trials Program, the review committee has the discretion to assign an "under continuing review (UCR)" rating to those applications where there is/are minor concern(s) or additional information/clarification is required to complete the review process. Following the peer review meeting, the relevant principal applicants are asked to respond to specific questions which are subsequently reviewed and assessed by the committee on an ad-hoc basis. Due to this process, announcement of the successful grants in this program may be delayed beyond the regular CIHR timelines.

    If you have any questions, please contact:

    Canadian Institutes of Health Research

    Room 97, 160 Elgin St.

    Address Locator 4809A

    Ottawa ON K1A 0W9

    Tel: (613) 957-6137, E-mail: ichikuru@cihr-irsc.gc.ca, or

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