What are the specific aspects of the phase 2 clinical trial of the drug?

Generally speaking, the first phase of clinical trials is mainly used to test the safety and tolerability of drugs, and the second phase is the effectiveness of drugs, strict selection of cases, setting up control groups (except for anticancer drugs), testing safety, recording short-term adverse reactions, determining the optimal dosage range, and recording the benefit and harm ratio. Generally, 25-100 patients are selected, and 500 cases are required for special cases.

1.Principles Balanced randomness (stratification, segmentation): random numbers, random grouping.

Blinding (non-blind, single-blind, double-blind) The whole process of the trial remained blind.

Control: blank, standard, comprehensive (test drug + known drug), placebo.

Multicentric. 2.Process: Formulation of standards - unification of standards--- start of the test--- end of the test--- summary meeting.

3.Blinded, drug grouping, subjects, monitors, physicians, statisticians.

4.Evaluation criteria: efficacy evaluation, safety evaluation.

Trials involving human subjects have traditionally been divided into 4 phases according to the chronological order of new drug development:

Period: A clinical trial in which the new drug is used in a small number of healthy subjects. The subjects were carefully selected to avoid any subjects in the group who were suffering from diseases or were taking barbars that were prohibited from being taken together.

The primary objective of this phase of the trial is to determine the human pharmacokinetic, pharmacodynamic and toxicological profile of the new drug.

Period: A first-in-time clinical trial in subjects with a new drug** indication. In this period, only a small number of patients can be strictly screened according to the exclusion criteria in the trial protocol, and the purpose of this period is to establish the appropriate dose, determine the dose-response relationship, evaluate the risk-benefit ratio, explore the compatibility of new drugs, and establish a methodological basis for the next trial.

At the same time, the commercial potential of the new drug will be concluded at the end of this trial.

Phase: Large-scale clinical trials to evaluate the efficacy and safety of new drugs. The primary objective of this phase of the trial is to obtain sufficient evidence to apply to the regulatory authority for approval of marketing authorization of a new drug. Research trials in specific patient populations, such as older patients, were also conducted in this phase.

Phase : Further clinical trials of a new drug after it has been approved for marketing. This includes comparative trials with competitors and post-market surveillance trials.

This phase is usually a large-scale clinical trial (enrolling thousands of participants from hundreds of investigators) to re-evaluate the efficacy and safety of a new drug. This helps to identify rare adverse drug reactions and to provide information on the practical clinical use of new drugs. Sometimes, clinical trials to expand the indication of a new drug are also called phase clinical trials, but some companies call them phase clinical trials.

There are four phases of clinical trials, and the first three phases are mainly related to you, which are called Phase I clinical trials, Phase II clinical trials, and Phase III clinical trials.

Phase I clinical trials mainly conduct two aspects of testing, on the one hand, to study the degree of tolerance of the human body to the drug, that is, to find out what is the maximum dose of the drug that can be used by a person once (or more); On the other hand, to study the metabolism of the drug in the human body, it is necessary to collect blood samples from the tester for analysis in the pharmacokinetic test, and the number and time interval of blood collection are different according to the different tests. Generally, the participants in phase 1 clinical trials are healthy people, and the number of participants required for this kind of trial is small, usually only about 20 people.

Phase II clinical trial: This stage is a preliminary evaluation of the drug's effect and safety. In this trial, patients are generally divided into two (or more groups), one of which uses the new drug in the trial and the other uses a control drug that is already on the market (i.e., available in a hospital or pharmacy).

Through the comparison of the efficacy and safety of new drugs and marketed drugs, the new drugs are evaluated accordingly. The number of participants in such trials is somewhat larger, and the state requires that the total number of trials not be less than 200.

Phase III clinical trial: This stage is the stage to confirm the first effect and safety of the new drug, so the number of trials required is more than the phase 2 clinical trial, China's regulations require that the number of people in the group using the test drug should not be less than 300 people, if you add the number of people in the group using the control drug, it can generally reach 400-500 people. Aside from the larger number of participants, phase III clinical trials and phase II clinical trials were similar in terms of trial design, execution, and evaluation.

In particular, it should be noted that in clinical trials, if the next phase of clinical trials is to be carried out, it must first pass the previous phases of clinical trials. Therefore, the phase III clinical trial is a clinical trial that has confirmed the safety and efficacy in previous studies, and it is only a clinical trial that has been validated in a larger number of patients, and it is highly recommended that patients participate in more phase III clinical trials.

Clinical trials of drugs are phased. The clinical trial in the middle stage should be completed before the drug is officially launched. The phase 4 clinical trial is conducted after the market.

Clinical trials are mainly used to study the efficacy and risks of drugs, and provide reliable data support for marketing review.

To put it simply, from the beginning of the development of a drug, it needs to be tested on animals and confirmed to be safe before it can enter the human trial stage. The purpose of phase 1 clinical trials is mainly to evaluate safety. Because the drug acts on the human body, safety is required to come first.

At the same time, the metabolism and excretion routes of drugs in the human body will also be investigated.

When the safety of the drug is confirmed in the Phase 1 clinical trial, it will enter the Phase 2 clinical trial. This phase is mainly to evaluate the effectiveness of the drug and at the same time to look at the safety in greater depth. In phase 2 clinical trials, the efficacy of the drug is evaluated and the specific dosage is determined.

After the safety is determined in the Phase 1 clinical trial and the efficacy is determined in the Phase 2 clinical trial, the Phase 3 clinical trial is entered. This stage is the most important stage before the drug is marketed, and a larger sample size (more than 300 cases is required) and a longer observation period (usually 1 3 years) will be used to further verify the effect and safety of the drug, evaluate the relationship between benefits and risks, and provide a sufficient basis for the review of the official marketing of the drug.

Phase 4 clinical trial is the applied research stage conducted by the applicant after the new drug is marketed. Its purpose is to investigate the efficacy and adverse effects of drugs under widely used conditions, to evaluate the benefits and risks of use in general or special populations, and to improve the dosage of drugs.

Clinical trials need to be ethical

The most important point of clinical trials is that they must meet the ethical requirements, that is, they must respect their personality and participate in the trial, and they must participate in the trial in the interests of the participants, and the experiment can only be done under this premise.

And during the trial, the participant can not continue the trial without any reason, and no one has the right to interfere with his (or her) choice, including the doctor. In short, well-designed and operated clinical trials are the fastest and safest way to improve human health and find new first-class drugs and methods.

Drug clinical trials are an essential step before a drug is marketed to confirm the efficacy and safety of a drug. Due to the particularity of the methods, means and purposes of drug clinical trials, it must follow the three basic principles of ethics and morality, scientific principles, GCP and current laws and regulations. And drug clinical trials must have a sound scientific basis.

Before conducting a human trial, the purpose of the trial and the problems to be solved must be carefully considered, and the expected benefits and risks to the subjects and public health should be weighed, and the expected benefits should outweigh the possible harm. The selection of clinical trial methods must comply with scientific and ethical requirements.

Drug clinical trials are generally divided into phase I, II, III, and IV clinical trials.

Phase I clinical trial: preliminary clinical pharmacology and human safety evaluation test. Observe the tolerance of the human body to the new drug and the pharmacokinetic process of the new drug in the human body, so as to provide a basis for formulating the dosing regimen.

Phase II clinical trials: preliminary evaluation of the efficacy and safety of the drug for patients with target indications, including providing a basis for the study design and dosing regimen of phase III clinical trials. The design of the study at this stage can take a variety of forms according to the specific research purpose, including randomized blinded controlled clinical trials, and clinical trials conducted by drug clinical trial institutions.

Phase III clinical trial: It is a continuation of the phase clinical trial, which aims to further verify the best effect and safety of the drug on patients with the target indication, evaluate the relationship between benefits and risks, and finally provide sufficient basis for the approval of the drug registration application. Trials should generally be randomised, blinded, controlled trials with sufficient sample size.

Phase IV clinical trial: The stage of applied research conducted by the applicant after the new drug is launched, also known as post-marketing surveillance. Its purpose is to investigate the efficacy, indications and adverse effects of drugs under widely used conditions;Evaluate the relationship between benefits and risks for use in general or special populations;Improve the dosage and guide the rational use of drugs in clinical practice.

The staging of clinical trials can be distinguished from the following aspects:

1. Purpose of the test:

Since the phase I clinical trial is the first drug experiment on humans, the main purpose is to study the safety and tolerability of the drug in humans, to investigate the relationship between drug side effects and drug dose escalation, and to investigate the human pharmacokinetic properties of the drug, including the identification of metabolites and the metabolic pathways of the drug in the human body.

Phase II clinical trials focus on the safety and efficacy of the drug. The efficacy of new drugs is evaluated by using placebo or marketed drugs as control drugs, and the impact of the occurrence and development of diseases on the efficacy of drugs is studied in the processTo determine the dosing dose and regimen for the phase III clinical trial;More information on the safety of the drug.

A phase IV clinical study is a clinical study conducted after a new drug has been marketed.

2. Number of subjects:

Phase I clinical trials require dozens of subjects, phase II clinical trials require dozens to hundreds of people, and phase III clinical trials generally require hundreds or even thousands of people, and most of them are multicenter trials worldwide. The phase IV clinical study calls for a phase IV trial of 2,000 cases.

3. Type of subject:

Phase I clinical trials are generally healthy subjects, in addition to some specific drugs such as anti-tumor drugs, anti-AIDS drugs, etc., sometimes specific subjects will be selected according to the needs of drugs and trial content, such as gender requirements (** medication, hormones, etc.); children or the elderly (for specific populations); Patients with impaired liver and kidney function (drugs for specific indications).

Phase II, III, and IV clinical trials generally select patients with the target indication.

Is there anything in this GCP? It seems to be briefly mentioned, and it is not detailed at all.

There are two main experiments, one is to study the tolerance of the human body to this drug, that is, to explore the maximum dose of the maximum available drug at one time (or more). On the other hand, the metabolic condition of this drug in the human body, i.e., pharmacokinetics, requires the blood sample of the experimenter to be taken from the pharmacokinetics for analysis, and the number and interval of blood sampling vary depending on the experiment. The people who participated in the first phase of the clinical trial were healthy people, but some drugs, such as cancer**, were carcinogenic or highly toxic, so most patients participated in the trial.

The number of participants required for such experiments is small, usually only 20 people.

This stage is a preliminary evaluation of the drug's action and safety. This experiment is patient participation, and the patients are generally divided into two or more groups, one group uses the new drug used in the experiment, and the other group uses a control drug that has already been marketed, which means that it can be purchased in a hospital or pharmacy. By comparing the efficacy and safety of new drugs with those on the market, new drugs are evaluated accordingly.

The number of participants in such experiments is somewhat larger, and the state requires that the total number of people in the experiments should not exceed 200.

According to China's regulations, the number of groups that need to use the experimental drug cannot be less than 300 people, plus the number of groups using control drugs, it can generally reach 400-500 people. In addition to the large number of people participating in the experiment, the Phase III clinical trial and the Phase II clinical trial were similar in terms of experimental design, execution, and evaluation.

New drugs use pharmacokinetic (absorption, distribution, metabolism, excretion) and bioassay data within a range of doses. New drugs generally do not require a control group in animal experiments, but sometimes placebo control can be performed in order to make a correct judgment about the specific symptoms that occur after the drug. Generally, 10-30 pieces are required, mainly in healthy volunteers, but some patients can also be selected.

The results of each experiment should be statistically processed, a complete and detailed experimental record should be made, and a formal written report should be written at the end. The first phase of clinical trials is mainly to study the tolerance of new drugs in the human body, put forward a preliminary, safe and effective dosing regimen, and guide the next stage of clinical trial research. The experiment was limited to the provincial health administration or a hospital designated by the Ministry of Health.