What are Clinical Trials?
Clinical Trial means any systematic study of drugs in humans (patients or healthy volunteers) to confirm or reveal the effects, adverse reactions, and / or absorption, distribution, metabolism and excretion of test drugs. It is to determine the efficacy and safety of the test drug. Clinical trials are generally divided into phase I, II, III, IV clinical trials and EAP clinical trials.
- Chinese name
- Clinical Trials
- Foreign name
- ClinicalTrial
- Make up
- Divided into I, II, III and EAP clinical trials.
- Purpose
- Determine the efficacy and safety of the test drug
- Author
- Daniel Steven
- Publishing house
- Yilin Press
- Clinical Trial means any systematic study of drugs in humans (patients or healthy volunteers) to confirm or reveal the effects, adverse reactions, and / or absorption, distribution, metabolism and excretion of test drugs. It is to determine the efficacy and safety of the test drug. Clinical trials are generally divided into phase I, II, III, IV clinical trials and EAP clinical trials.
Clinical trial
- According to the definition of clinical trials in the "Good Manufacturing Practices for Drug Clinical Trials" issued by the State Food and Drug Administration, clinical trials refer to any systematic study of drugs in the human body (patients or healthy volunteers) to confirm or reveal test drugs Effects, adverse reactions, and / or absorption, distribution, metabolism, and excretion of the test drug in order to determine the efficacy and safety of the test drug. In foreign countries, people participating in clinical trials are referred to as volunteers, and domestically referred to as "subjects". Volunteers include healthy people and patients, which mainly depends on what kind of trials they participate in. The trials that we usually contact the most are still participated by patients. The purpose is to examine whether the new drug has an effect and whether there are side effects. To put it another way, the more straightforward way is that before a new drug is officially launched, doctors take it ( Use) This new drug, of course, must be agreed by the patient. After a certain course of treatment, look at the efficacy and side effects of this drug. The most important point of a clinical trial is that it must meet our ethical requirements, that is, the person participating in the trial must respect his or her personality, and participate in the trial must conform to the interests of the participant. Under this premise, the trial can only be performed. . Moreover, during the trial, the participant may not need any reason to continue the trial, and his or her choices, and no one, including the doctor, has the right to interfere. In short, well-designed and operated clinical trials are the fastest and safest way to improve human health and find new therapeutic drugs and methods. [1]
Clinical trial content
Clinical trial
- Including preliminary clinical pharmacology, human safety evaluation tests, and pharmacokinetic tests, to provide a basis for formulating a drug delivery plan. Including: Tolerance test: preliminary understanding of the safety of the test drug to the human body, and observation of human tolerance to the test drug and adverse reactions. Pharmacokinetic test: Understand the human body's treatment of the test drug, that is, the absorption, distribution, metabolism, and elimination of the test drug.
- Before the start of the trial, the clinical trial approval of the State Food and Drug Administration (CFDA for short) must be obtained.
- Design of clinical research plan, preparation of record form, and formulation of SOP.
- The ethics committee reviewed the trial-related documents such as the phase I clinical research plan, informed consent, and case report form.
- Researcher training, preparation of ward I
- Volunteer subjects were selected initially through physical examination, and then further comprehensive examination was conducted, and those who passed were selected.
- Before the start of the test, sign the informed consent form for the eligible subjects.
- Single dose tolerance test
- Multi-dose tolerance test
- Data entry and statistical analysis
- Summary analysis
Phase II clinical trial
- Preliminary evaluation of therapeutic effects. The purpose is to initially evaluate the therapeutic effect and safety of the drug in patients with target indications, and also to provide evidence for the design of phase III clinical trials and the determination of dosing schedules. The study design at this stage can take a variety of forms, including randomized blind controlled clinical trials, depending on the specific research purpose. Phase II trials must include a control group for a blind randomized controlled trial, often using a double-blind, randomized, parallel controlled clinical trial. Sponsors of double-blind trials are required to provide test drugs and control drugs with the same appearance, color and fragrance, and only indicate drug A and B. The tester and the subject do not know which of A and B is the test drug. If it is really difficult to prepare the two drugs without difference between A and B, the double-blind, double-dummy technique (Double-Blind, Double Dummy Technique) can be used. The placebo (D), two groups of patients were randomly divided into two groups, each taking two drugs, one taking A + D and the other taking B + C. There was no difference between the two groups in the appearance, color, and flavor of the drugs.
Phase III clinical trial
- Confirmation of treatment effect. The purpose is to further verify the therapeutic effect and safety of drugs on patients with target indications, evaluate the relationship between benefits and risks, and ultimately provide a sufficient basis for the review of drug registration applications. The trial should generally be a randomized, blinded controlled trial with a sufficient sample size.
- The design requirements for controlled trials in phase III clinical trials are basically the same as those in phase II blind randomized controlled trials, but phase III clinical controlled trials can be blinded or randomized controlled randomized open trials (Randomized Controlled Open Labeled Clinical Trial) . Certain drug classes, such as cardiovascular disease drugs, often have both short-term testing purposes such as observing the effects on blood pressure and lipids in a certain period of time, and long-term testing objectives such as comparing the mortality of the disease or the incidence of serious complications after long-term treatment. Wait, the phase III clinical trial is not only to expand the number of cases in the phase II trial, but also to carry out detailed design and make careful arrangements according to the purpose and requirements of long-term trials in order to obtain scientific conclusions.
Phase IV clinical trial
- Phase IV clinical trials are the stages of applied research conducted by the applicant after the new drug is marketed. The purpose is to investigate the efficacy and adverse reactions of the drug under widely used conditions, evaluate the relationship between the benefits and risks of use in the general or special population, and improve the dosage.
- Technical characteristics of phase IV clinical trials:
- Phase clinical trials are open trials after they are marketed. There is no requirement for a control group, but it is not ruled out that a small sample randomized controlled trial of certain indications or certain test subjects is required.
- The number of clinical trials in Phase IV is in accordance with SFDA regulations, and the requirement is> 2000.
- Although the phase clinical trial is an open trial, the relevant criteria for inclusion, exclusion, withdrawal, efficacy evaluation, adverse reaction evaluation, and evaluation of clinical efficacy and adverse reactions can be referred to the phase clinical trial. Design requirements.
- EAP clinical trial (expanded access program)
- EAP clinical trial refers to a type of clinical trial carried out by pharmaceutical companies in order to allow patients with severe diseases and not suitable to participate in controlled trials to obtain treatment for new drugs that are currently in clinical trials under certain conditions.
- The vast majority of new drug clinical trials use a controlled design to evaluate the safety and effectiveness of new drugs. Data from these clinical trials can often be used to determine whether the drug is safe and effective and serve as the basis for drug marketing applications. However, sometimes patients are not eligible for these controlled trials due to their own health, age, and other factors, or for other reasons (for example, the patient resides too far from the clinical research center).
- These patients with severe diseases may benefit from the treatment of the new drug, but they cannot participate in clinical trials of the drug. In order to benefit this type of patients as well, the FDA allows manufacturers of these drugs to provide those patients with the opportunity to obtain new drug treatments under certain conditions, which is called an "expanded approach." [2]
Examples of clinical trial parameters
|
|
|
|
|
|
|
|
|
|
| Not less than 100 cases |
|
|
| Not less than 300 cases |
| Further investigation of the safety and effectiveness of new drugs | Efficacy and adverse effects of drugs | > 2000 cases |
| EAP clinical trial | New drug treatment for patients unsuitable for clinical trials | Efficacy endpoints, and safety data |