What Is Clinical Trial Monitoring?

In order to guide the clinical trials of in vitro diagnostic reagents, in accordance with the "Administrative Measures for the Registration of In vitro Diagnostic Reagents" (Order of the State Food and Drug Administration No. 5), the State Food and Drug Administration has formulated the "Technical Guiding Principles for Clinical Tests of In vitro Diagnostic Reagents" ". ^[1]

Guidelines for clinical testing of in vitro diagnostic reagents

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In order to guide the clinical trials of in vitro diagnostic reagents, in accordance with the "Administrative Measures for the Registration of In vitro Diagnostic Reagents" (Order of the State Food and Drug Administration No. 5), the State Food and Drug Administration has formulated the "Technical Guiding Principles for Clinical Tests of In vitro Diagnostic Reagents" ". ^[1]

Clinical tests of in vitro diagnostic reagents (including comparative research tests with products already on the market) refer to the systematic study of the clinical performance of in vitro diagnostic reagents in the corresponding clinical environment.

Applicants should formulate a clinical trial plan that can prove their clinical performance according to the expected clinical use of the product, the prevalence of related diseases, and statistical requirements on the premise that the clinical unit that meets the requirements meets the minimum sample size requirements for clinical trials. Maximize control of test errors, improve test quality, and conduct scientific and reasonable analysis of test results. A clinical trial report is a summary of the clinical trial process and results. It is an important basis for evaluating the effectiveness and safety of a product to be marketed. It is one of the important documents required for product registration.

This guideline only provides general requirements for clinical trials of in vitro diagnostic reagents. Due to the characteristics of rapid development of in vitro diagnostic reagent products, large professional span, and different clinical intended uses, the clinical trial methods and contents of different clinical intended products are different. Applicants should formulate a reasonable clinical trial plan based on product characteristics and clinical intended use. The State Food and Drug Administration will also revise these guidelines in due course according to the needs of the development of in vitro diagnostic reagents. ^[1]

(I) Basic requirements

1. Clinical trials must comply with the ethical guidelines of the Helsinki Declaration and must be approved by the ethics committee of the clinical trial institution. The researcher should consider the clinical trial samples, such as blood, amniotic fluid, pleural fluid, ascites, interstitial fluid, pleural effusion, tissue sections, bone marrow, etc., or the risk of the test results to the subject. Subject's informed consent. For exceptions, if it is objectively impossible to obtain the subject's informed consent or the clinical trial has little risk to the subject, the subject's informed consent can be exempted after review and approval by the ethics committee.

2. The rights, safety, and health of the subject must override scientific and social interests.

3 Keep subjects confidential and respect personal privacy. Prevent subjects from being discriminated against or harmed by test results.

4 Results from preclinical studies support clinical trials. ^[1]

(I) Clinical trial plan

To carry out a clinical test of an in vitro diagnostic reagent, the applicant shall organize the formulation of a scientific and reasonable clinical trial protocol according to the characteristics, risks, and intended uses of the in vitro diagnostic reagent for the test. It should generally include the following:

1. General information (including product information, relevant information such as the time and personnel of the clinical trial, and relevant information of the applicant, etc.);

2. Background information of clinical trials;

3. Test purpose;

4. Experiment design;

5. Evaluation method;

6. Statistical methods;

7. Provisions for amendments to clinical trial protocols;

8. Ethical issues and instructions involved in the clinical trial, and the text of the "Informed Consent Form" (if any);

9.Data processing and record keeping;

10. Other contents to be explained. ^[1]

The clinical trial report should give a clear and complete description of the overall design of the trial and its key points. It should describe the trial implementation process in a structured manner, including the necessary basic data and statistical analysis methods.

The applicant or the lead unit of clinical trials shall summarize the reports of each clinical trial institution and complete the clinical trial summary report. The format and content of the clinical trial report are as follows:

(A) the first article

The first part is the first part of each clinical trial report, and all clinical trial reports should include this part.

1. Cover title

Including the general name of the test in vitro diagnostic reagent, the test start date, the test completion date, the principal investigator (signature), the clinical trial institution (seal), the signature of the person in charge of statistics and the unit seal, the applicant (seal), The applicant's contact person and contact information, the date of the report, and the place where the original information is kept.

2. table of Contents

List the contents and corresponding page numbers of the entire clinical trial report.

3 Research Summary

A brief introduction to clinical trials.

4 Experimental researcher

List the names, units, responsibilities, and resumes of the main investigators in the clinical trials (listed in the attachment). The main investigators include the main investigators and the main participants in each unit, the person in charge of statistics, and the clinical trial report. Writer.

5. Acronyms

The full name of the acronym used in the clinical trial report.

(B) the body content and report format

1. Fundamental contents

1.1 Introduction.

Introduce background information related to clinical trial products: including (1) the source, biological and physical and chemical properties of the test substance; (2) the intended clinical use purpose, the target indication population targeted, and the clinical practice currently used for the indication Or laboratory diagnostic methods; (3) methods, principles, technical requirements, etc .; (4) application status of products that have been approved for listing at home and abroad. Describe the cooperative relationship between the applicant and the clinical trial institution.

1.2 Research purposes.

Explain the purpose of this clinical trial.

1.3 Test management.

A description of the trial management structure.

The management structure includes the main researcher, main participants, laboratory quality control, statistics / data management, and problems and their treatment during the experiment.

1.4 Experimental design.

1.4.1 Description of overall test design and plan.

The overall design of the trial and the description of the plan should be clear and concise, and visual methods such as diagrams should be used if necessary. Modifications to the protocol during the test and any sources of information other than the protocol should also be described in detail.

1.4.2 Test design and test method selection.

The test design should include the following:

(1) Sample size and basis for determining sample size.

(2) Sample selection basis, selection criteria, exclusion criteria and rejection criteria.

(3) Sample collection, preservation, and transportation methods.

(4) Establishment of "gold standard" or contrast reagent.

(5) The names, specifications, sources, batch numbers, expiration dates, and storage conditions of all products used in clinical trials, compared with the registration of reagents.

(6) Quality control methods. Briefly explain the quality control methods.

(7) Statistical analysis of clinical trial data.

(8) Modification of the plan during the test.

In general, the clinical trial protocol should not be changed. Any modification to the plan during the test should be explained, and the time, reason, process of change, and whether there is a record of the change should be explained in detail and its impact on the evaluation of the entire research results.

1.5 Clinical trial results and analysis.

1.6 Discussion and conclusions.

2. Explanation of special circumstances in clinical trials

3 annex

3.1 Basic information of other test methods or other diagnostic reagent products used in clinical trials, such as test methods, diagnostic reagent product sources, product specifications, and registration approval status.

3.2 All test data in clinical trials must be signed by the clinical trial operator and reviewer, and the clinical trial institution's seal (cover seal and saddle seal).

3.3 Main references.

3.4 Resume of the principal investigator.

3.5 Other circumstances that the applicant needs to explain.

An in vitro diagnostic reagent for a test refers to an in vitro diagnostic reagent to be applied for registration, which confirms its safety and effectiveness in a clinical trial.

A clinical trial protocol refers to documents such as the title, purpose, design, methodology, statistical considerations, and organization of a clinical trial. It also usually includes the background and theoretical basis of the trial.

A researcher is a person who is responsible for conducting a clinical trial in a clinical trial facility. If a group of people conducts a trial in a clinical trial facility, the researcher refers to the person in charge of the group, also called the main research By.

Subjects refer to individuals who are recruited to participate in clinical trials, and can be either those who are tested by in vitro diagnostic reagents for testing in clinical trials, or control persons.

Informed consent is the process of confirming voluntary participation in a clinical trial after the subject is informed of all aspects of a trial. The signed and dated informed consent form must be used as proof.

Informed consent refers to the documentary evidence of each participant's voluntary participation in a trial. The researcher needs to explain the nature of the trial, the purpose of the trial, possible benefits and risks, other diagnostic and therapeutic methods available, and the rights and obligations of the subjects in accordance with the Helsinki Declaration, so that the subjects can fully understand After voluntarily expressing his consent to participate in a clinical trial.

The ethics committee refers to an independent organization composed of medical professionals and non-medical professionals in a clinical trial institution. Its responsibility is to review the scientific and ethical aspects of clinical trials, specifically to approve clinical trial protocols, Researcher qualifications, facilities, and methods of informed consent are reviewed and relevant opinions are provided to ensure that subjects' safety, health, and rights are fully protected.

Standard operating procedures refer to standard and detailed written procedures formulated for the effective implementation and completion of each task in a clinical trial.