How to write a clinical trial protocol

Medical device clinical trial program should be to maximize the protection of the rights and interests of the subjects, safety and health as the primary principle, should be responsible for the clinical trial of the medical institutions and implementers in accordance with the prescribed format (Annex 2) *** with the design of the development of the ethical committee approved by the implementation of the report; if there is a modification, it must be agreed by the Ethics Committee.

The market has not yet appeared in the third type of implantation or borrowed from the theory of Chinese medicine made of medical devices, clinical trial program should be filed with the medical device technical review body.

Adverse events of similar medical devices already on the market, or the efficacy of medical devices is not clear, the State Food and Drug Administration can develop a unified clinical trial program provisions.

To carry out clinical trials of such medical devices, implementers, medical institutions and clinical trial staff should implement the provisions of the unified clinical trial program.

Medical device clinical trial program should be specific to the characteristics of the product under test, to determine the number of clinical trials, duration and clinical evaluation criteria, so that the test results are statistically significant.

Medical device clinical trial program should prove the theoretical principles of the test product, the basic structure, performance and other elements of the basic situation and the safety and effectiveness of the test product.

Medical device clinical validation program should prove that the main structure, performance and other elements of the test product and the marketed products are substantially equivalent, whether the same safety, effectiveness.

The medical device clinical trial program should include the following:

(a) the title of the clinical trial;

(b) the purpose, background and content of the clinical trial;

(c) the clinical evaluation criteria;

(d) the risk and benefit analysis of the clinical trial;

(e) the name of the clinical trial personnel, position, title and department of employment;

(vi) overall design, including analysis of the likelihood of success or failure;

(vii) duration of the clinical trial and the rationale for its determination;

(viii) the number of cases of the clinical trial for each disease and the rationale for its determination;

(ix) the scope of the selection of the subjects, the number of subjects, and the rationale for the selection, and, if necessary, the setup of the control group;

(j) therapeutic products should have a clear indication or scope of application;

(k) the evaluation method of clinical performance and statistical treatment;

(l) side effect prediction and measures that should be taken;

(m) the subjects of the "Informed Consent";

(xiv) the responsibilities of all parties.

The medical institution and the implementer sign the clinical trial program agreed by both parties, and sign the clinical trial contract.

Medical device clinical trials should be conducted in more than two (including two) medical institutions.