What are the number of clinical trial cases? What information is required for the ethics of the drug

I consulted with the Central Security Office, and the case allocation for each indication is statistically significant.

The project leader and principal investigator of the clinical trial institution submit an application for ethical review of biomedical research. The Secretary of the Ethics Committee shall accept the application and notify the application number in writing, or inform the application of the deficiencies that need to be supplemented, as well as the deadline for submission of additional materials in relation to the date of review. Materials include:

Application form (signed and dated by the applicant).

A summary of the preclinical research data of the application project, including review data, pharmaceutical research data, pharmacology and toxicology research data, a summary of the clinical experience of the project so far, as well as reference quality standards and clinical research literature.

The clinical study protocol, including a statement and signature page of the principal investigator of each trial site agreeing to follow the GCP principles and trial protocol, indicating the date of the version.

Summary of the clinical study protocol, including a description of the process for obtaining and demonstrating informed consent; A description of any compensation given to the subject as a result of participation in the study (including transportation expenses, testing nutrition costs, compensation for lost work, and medical care); insurance coverage for the subject; A description of the cost, compensation, and/or compensation arrangements for damages suffered by the subject as a result of participating in the clinical trial. Indicate the date of the edition.

Investigator's Handbook.

Study medical records and or case report forms.

Subject diary cards and other questionnaire forms.

Study profile and informed consent form provided to the subject, indicating the date of the version.

Materials used to recruit subjects (including notices, advertisements).

Professional history of the principal investigator of each trial center (up-to-date, signed and dated).

All previous significant decisions (including negative conclusions or modifications to the protocol) of the proposed research project (whether at the same location or elsewhere) and a description of the modification of the protocol. Justification for previous negative conclusions should be provided.

Copies equal to the number of participants in the above items must be provided, and the application materials should be in Chinese.

Hope it works for you

Ask the clinical trial organization of the hospital where the clinical trial is doing it, and ask for a list of ethical materials to be submitted.

From a test point of view, it doesn't make much difference.

Phase III and Mediator are both registered trials.

The mediator may be exempt from testing or require a very simple test.

The phase III requirements for chemical drugs are relatively strict and the cost is high.

Phase IV is generally open, and the design is not as strict as that of Phase III, but if the sample size is large, of course, it is also very expensive, such as thousands of cases.

In principle, the renewal varieties of the insurance are required to refer to the clinical requirements of phase 3, and the ratio is 3:1, but there is another one that meets the statistical requirements, as long as the composite statistical requirements are not necessarily 60 pairs, but can also be a 2:1 ratio.

The four indications can be boiled down to 1-2 syndromes, and a syndrome of traditional Chinese medicine often includes several diseases of Western medicine, such as chronic obstructive pulmonary disease, if not, you have to choose the second one to do enough 60 cases, or choose the third one, to do enough 50 cases each. The ratio is 2:1

The requirements for the renewal of the insurance are not very strict, and it is generally very good to do the above. You can also ask for advice from a statistical expert.

Clinical guidelines need to be flexible, not immutable dogma.

If the same control drug is selected, it cannot be carried out at the same time, but another problem is that there is a deadline for the renewal of the insurance policy, and I believe that both manufacturers have schedule requirements.