2020. 2. 29. 04:30ㆍ카테고리 없음
As displayed in the Federal Register notice on August 29, 2018, FDA is conducting a Complex Innovative Trial Design (CID) Pilot Meeting Program to support the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs. The CID Pilot Meeting Program fulfills a performance goal agreed to under PDUFA VI, included as part of the FDA Reauthorization Act of 2017.This pilot meeting program offers sponsors whose meeting requests are granted the opportunity for increased interaction with FDA staff to discuss their proposed CID approach.Meetings will be conducted by FDA’s (CDER) and (CBER) during fiscal years 2019 to 2022. To promote innovation in this area, trial designs developed through the pilot meeting program may be presented by FDA (e.g., in a guidance or public workshop) as case studies, including trial designs for medical products that have not yet been approved by FDA.New! (PDF - 438KB).
CID Pilot Meeting ProgramQuarterly meeting request submission deadlinesMarch 31June 30Sept. 31Applicants will be notified of eligibility to proceed to disclosure discussions approximately 45 days after submission deadlines.Under the CID pilot meeting program, FDA will accept two primary meeting requests and two alternates per quarter. For each meeting request granted as part of the pilot, FDA will conduct an initial meeting and a follow-up meeting on the same CID and medical product within a span of approximately 120 days. FDA welcomes submissions related to any eligible CID. However, given that FDA expects to grant up to two meeting requests per quarter as part of the pilot program, FDA will select requests based on:. Innovative features of the trial design, particularly whether the innovation may provide advantages over alternative approaches. Initial priority will be given to trial designs for which (1) analytically derived properties (e.g., type I error) may not be feasible and (2) simulations are necessary to determine operating characteristics.
Therapeutic need (i.e., therapies being developed for use in disease areas where there are no or limited treatments). Sponsors may request to participate in the program on a rolling basis through June 30, 2022. Only those requests received by the last day of each quarter of the fiscal year will be considered for the following quarter. Meeting-granted and -denied decisions and notifications will be made within 45 days after the quarterly closing date.Meeting requests should be submitted electronically to the relevant application (i.e., pre-IND, IND) with “CID Pilot Program Meeting Request for CDER” (CDER applications) or “CID Pilot Program Meeting Request for CBER” (CBER applications) in the subject line. Please review the information about.
Within 45 days after the quarterly closing date, FDA will review the meeting requests, select up to four meeting requests each quarter (two primary and two alternates) to proceed to disclosure discussions, and notify sponsors of their status. Before FDA grants the initial meeting under the CID pilot meeting program, FDA and the sponsor must discuss and agree on the information that FDA may include in public case studies. The specific information to be disclosed will depend on the content of each meeting request and associated CID.
FDA intends to focus on information that is beneficial to advancing the use of CIDs, and those elements relevant to the understanding of the CID and its potential use in a clinical trial intended to support regulatory approval. Sponsors whose meeting requests are granted as part of the pilot program should submit a meeting information package electronically no later than 30 days before the initial meeting and no later than 90 days before the follow-up meeting.What is the Complex Innovative Trial Design (CID) Pilot Meeting Program?
Response: Officially launched with the publication of a Federal Register Notice in August 2018, the CID Pilot Meeting Program is a U.S. Food and Drug Administration (FDA)-led pilot meeting program which supports the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs. Under the sixth iteration of the Prescription Drugs User Fee Amendments (PDUFA VI), FDA agreed to conduct a pilot meeting program for highly innovative trial designs for which analytically derived properties may not be feasible, and simulations are necessary to determine trial operating characteristics (e.g.
Type 1 error).This program offers sponsors who are selected an opportunity for increased engagement with FDA experts from the Center for Drug Evaluation and Research (CDER) and/or Center for Biologics Evaluation and Research (CBER) to discuss CID and analyses in medical product development. The pilot program period will be conducted through September 30, 2022. What is Type I error?Response: Clinical trials are conducted to provide evidence that a medical product is both safe and effective. The FDA’s evaluation of clinical trials often includes an assessment of the type I error, which is the probability of falsely concluding that a medical product has an effect when it does not.
How can CIDs streamline the drug development process?Response: CIDs and analyses can help streamline the drug development process by increasing the efficiency of clinical trials. For example, clinical trials with adaptive designs may allow for a greater chance of detecting a drug effect at a given expected sample size by allowing for dropping a less effective treatment arm. Other adaptive designs may allow for stopping a trial early if there is persuasive evidence that the drug is highly effective. Has the FDA approved any drugs using CIDs?Response: A CID was used in the Partnership for Research on Ebola Virus in Liberia II trial to test potential Ebola therapies under a single protocol; this trial was stopped as the Ebola outbreak waned, and no drugs were approved using data from this trial.
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The few examples of CIDs being used in trials intended to support regulatory decision making is one of the motivations behind creating the pilot meeting program. When is FDA accepting proposals (meeting requests) for the CID pilot meeting program?Response: To apply for the CID pilot, sponsors should submit a meeting request to the CID Pilot Meeting Program. The FDA began accepting meeting requests with the publication of the Federal Register Notice on August 30, 2018. Meeting requests received by the end of each quarter (e.g.
March 31, June 30, September 30, December 31) will be screened for eligibility and reviewed in the following quarter. Within 45 days after the quarter closing date, FDA will notify the sponsor whether their request will proceed to disclosure discussions or is denied.