Clinical trial requirements for clinical drug registration management

Drug clinical trials refer to the process of continuous exploration and verification of new drug effects, drug dosages, and adverse reactions for the purpose of drug market registration.

In order for a patient to participate in a clinical trial, what conditions need to be met in order to meet the requirements of a clinical trial? The admission criteria for clinical trials are designed by professionals

The physical condition of clinical trial participants must be checked before entering the group

For some cancer patients, after the first-line treatment fails, and evidence is needed to prove that the first-line treatment fails, they have the opportunity to participate in a clinical trial.

Drug clinical trial application : The drug review center shall organize pharmacy, medical and other technical personnel to review the accepted drug clinical trial application

Time limit requirements for clinical trials: drug clinical trials should be implemented within three years after approval

If the ethics committee is approved to carry out drug clinical trials, the sponsor shall formulate a corresponding drug clinical trial plan before conducting subsequent phased drug clinical trials, which shall be carried out after the review and approval of the ethics committee, and submit the corresponding drug clinical trials on the website of the Drug Evaluation Center Programs and supporting materials

Drug clinical trial registration and information disclosure platform.

A clinical trial corresponds to a trial protocol number, and only one record can be registered

The first registration, submission and publicity of each trial information must be completed before the first subject enters the group

Not all registered information will be disclosed to the public through the platform

Phase I clinical trials are mainly to study people's tolerance to new drugs and propose a preliminary, safe and effective dosing plan to guide the next phase of clinical trials

Phase II clinical trials are the preliminary evaluation phase of drug treatment effects

Phase III clinical trials are the stage of confirmation of the therapeutic effect

Phase IV clinical trials are the applied research phases conducted by the applicant after the new drug is marketed

Bioequivalence test (BE) refers to the use of bioavailability research methods, using pharmacokinetic parameters as indicators to compare the same or different dosage forms of the same drug, under the same test conditions, the absorption of its active ingredients The human body test whether the degree and speed are statistically different, the test subjects are healthy volunteers, generally 18-24 cases are required