This article will take you closer to this "clinical trial" which is closely related to our health but so unfamiliar.
1, what is a drug clinical trial?
According to the Quality Management Standard for Drug Clinical Trials issued by the national drug regulatory authorities, drug clinical trials refer to any systematic drug research conducted in human bodies (patients or healthy volunteers) for the purpose of confirming or revealing the effects, adverse reactions and/or absorption, distribution, metabolism and excretion of drugs, and for the purpose of determining the efficacy and safety of drugs.
2. What are the steps for a new drug to go on the market?
After the first, second and third clinical trials, a new drug can apply to China Food and Drug Administration (CFDA) for marketing. Once the new drug is approved for marketing, it can be sold in the market.
The listing of new drugs must go through G "X" P, including: the drug research part should conform to GLP (Quality Management Standard for Non-clinical Research of Drugs), the drug clinical trial should conform to GCP (Quality Management Standard for Clinical Trial of Drugs), the drug production should conform to GMP (good manufacturing practice), and the drug sales should conform to GSP (Quality Management Standard for Drug Business).
According to statistics, it generally takes more than 10 years for a new drug to go from basic research to marketing approval, and the average research and development cost of each new drug is about 300-500 million dollars, of which 50%-70% of the cost and time are spent on clinical trials, which shows the importance of clinical trials.
3. What should drug clinical trial institutions do?
Domestic drug clinical trial institutions need to be certified by CFDA before they are qualified to carry out clinical trials. The institutional work includes a series of work such as trial quality management, file system management, trial drug management, clinical coordinator (CRC) service, and file management, so as to ensure the scientific, ethical and compliance of clinical trials and ensure the smooth and standardized development of clinical trials. Clinical trials must be conducted in hospitals before drugs are put on the market. After the test, you can apply for listing, that is, you can sell it!
The drugs you bought in pharmacies and hospitals have all been clinically tested by hospitals, and can only be sold after statistical analysis by statistical experts and approval by CFDA.
4. What is the theme?
Participants in clinical trials are often referred to as "subjects". Respecting the personality and human rights of the subjects and fully protecting the rights and interests of the subjects is theNo. 1 of the clinical trial.
Subjects are an important part of biomedical research. They are not only carriers of passive research, but also collaborators of innovative interactive research, including patients and healthy volunteers.
5. Why do drug clinical trials need healthy volunteers?
The first phase clinical trial takes healthy volunteers as the main subjects to study the human body's reaction and tolerance to new drugs, explore safe and effective dosage, put forward reasonable administration scheme and matters needing attention, provide basis for the administration scheme of the second phase clinical trial, and study the pharmacokinetics of drugs in vivo, such as absorption, distribution, metabolism and excretion.
6. Is it safe to participate in drug clinical trials?
Clinical trials of drugs (including bioequivalence tests) must be approved by the state drug supervision and administration department.
Because it involves human trials, in order to ensure the personal safety and health of patients or healthy volunteers participating in the trials, the approval process of clinical trials is very strict. Pharmaceutical enterprises or research institutions that study new drugs should conduct a lot of laboratory research to obtain experimental data on the efficacy and safety of animals and other pharmaceutical data. All these studies have detailed technical guidelines that need to be standardized and approved by the State Administration of Medical Products, which is only the first step before clinical trials. If clinical trials are to be implemented, they must be reviewed by an independent ethics committee.
Every hospital that can conduct clinical trials has an independent ethics committee composed of doctors and other professionals (outside units), which is responsible for ethical review of clinical trials conducted in this hospital, which is another effective measure to ensure the safety and rights of participants. Ethical audit will comprehensively weigh the benefits (benefits) and risks of participating in the experiment. Only when the benefits of participating in the trial outweigh the risks, the clinical trial will pass the audit of the independent ethics Committee, and then the doctor will conduct the clinical trial as required.
7. What are the benefits of participating in clinical trials?
(1) can make patients fully understand the current international treatment level and the latest progress of their own diseases, and understand the prognosis of their own diseases and the curative effect that can be achieved by current standardized treatment;
(2) Most clinical trials provide experimental drugs or treatments free of charge, and patients receiving new drugs may get additional curative effects from clinical trials, such as curing, prolonging survival time or relieving pain, which may be beyond the reach of conventional treatment or have low curative effects;
(3) Participating in clinical trials may also enable patients to benefit from new drugs one step ahead of schedule. For example, patients who participated in the clinical trials of new drugs such as letrozole have achieved better curative effects than tamoxifen in both the rescue treatment of advanced breast cancer and the adjuvant treatment of early breast cancer.
(4) Finally, participating in clinical trials will give patients better care and attention.
8. How to protect the rights and interests of participants in clinical trials?
The rights and interests, safety and health of the subjects must be higher than the consideration of scientific and social interests. Ethics Committee and informed consent form are the main measures to protect the rights and interests of subjects.
Before clinical trials of new drugs, they must be reviewed by the ethics committee. Members of the Ethics Committee include medical and pharmaceutical experts, legal professionals, media and community representatives. They have nothing to do with the trial. Only after their review, they think that clinical trials are in line with the principle of patients' voluntariness and will not harm patients' interests can they be tested. Even in the course of the trial, once there is a situation that may endanger the interests of patients, regardless of the stage of the trial, you can apply for suspension and get assistance immediately after the evaluation. Because in all clinical trials, we must abide by the highest criterion, that is, "the interests of patients are higher than the interests of science and medicine."
9. What should I consider before participating in clinical trials?
Before participating in the clinical trial, you should know as much as possible about the clinical situation, and don't be embarrassed to consult the members of the clinical trial group. The following questions may be useful for people who want to participate in clinical trials. The answers to these questions can be found in the informed consent form.
(1) What is the purpose of this study?
(2) What kind of people can participate in this clinical trial?
(3) Why do researchers think this treatment is more effective? Has this treatment been tested before?
(4) What experimental examinations and treatments should be carried out?
(5) What are the risks, side effects and benefits of this clinical trial compared with the current treatment methods?
(6) What impact does this clinical trial have on daily life?
(7) How long will this clinical trial take to complete?
(8) Do you need to be hospitalized?
(9) Who will pay for this treatment?
(10) Is there any other charge?
(1 1) What are the types of long-term follow-up treatment in this study?
(12) How to guide effective treatment? Can you show me the test results?
Who is in charge of my treatment and care?
10, what do doctors need to do in clinical trials?
After joining the clinical trial, you need to go back to the hospital on time according to the requirements of the research doctor. And actively cooperate with doctors to complete this clinical trial. After you finish the treatment, the study doctor may ask you for long-term follow-up. You need to go back to the hospital regularly for follow-up visits or telephone follow-up to understand your future physical condition, so as to understand the long-term effect of this study.
1 1. Is personal information confidential when participating in clinical trials?
Your personal information will be kept strictly confidential as required.
Relevant personnel, researchers, ethics committees and drug supervision and administration departments of the applicant will be allowed to consult your medical records. The purpose of consultation is to ensure the accuracy of the whole research information and the correct implementation of the research plan. Your personal data will not be disclosed in any public report on the results of this study.
12. Can I withdraw from the clinical trial?
You can apply for quitting at any time.
Clinical trials are voluntary. You can refuse to participate or quit at any time, and you won't suffer losses or lose your original rights and interests.
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