In the publicity column of large hospitals, I sometimes see such recruitment advertisements, < < so-and-so clinical trials recruit volunteers > >. Some patients are eager to try after seeing them, but more patients are deterred after seeing them. What leads to the deterrence is such a question: [clinical trials], do you take me as a mouse?
According to the global clinical trial progress report of the Cochrane Methodology Register (CMR), from 2000 to 2006, the number of subjects participating in global clinical trials accounted for 41% in the United States, while the proportion in China was less than 1%.
The data gap between China and the United States brings us such a thinking. Is China’s clinical trials really a scourge? What is a clinical trial? In the doctor’s mouth, Mention clinical trials, It is often replaced by an English phrase, called GCP (Good Clinical Practice), literally, Is the good clinical decision-making practice, The official name is “Quality Management Specification for Clinical Trials of Drugs”. Before each new drug is widely used in clinical practice, All need to carry out clinical trials under the guidance of GCP. It not only requires drug producers to provide valuable clinical data, but also pays more attention to the protection of the safety and interests of subjects or patients during the trial. The specific content of clinical trials is what? The clinical trial is divided into four phases, each phase of the subjects and the purpose of the test are different. Phase I, the main subjects are healthy volunteers or a small number of patients, mainly within a safe dose range, to observe how the new drug metabolizes in the human body and how the human body responds to the new drug; In Phase II, the main subjects are patients within the indications. What they want to observe is the initial therapeutic effect and safety of this new drug. Phase III is a further confirmation based on the test results of Phase II. The subjects are also patients within the indications. Phase IV, the research phase after the new drug is put on the market, mainly observes the curative effect and adverse reactions after the new drug is widely used, providing reference for reducing the risk of adverse reactions and improving the dosage of drugs. Is clinical trials safe for subjects? All clinical trials are to protect the rights and interests of subjects as the first priority! GCP mainly from the following aspects, Protecting the rights and interests of subjects: 1. Sign Informed Consent Before the subject decides to participate in clinical trials, Doctors will assess whether the subject’s condition or physical condition is suitable for clinical trials. For the suitable population, Doctors will inform the subjects of the relevant contents of clinical trials, including: initiator, target, observation target, rights and interests of the subjects, etc. Only when the subjects fully know and agree can they sign the informed consent form; 2. The ethics committee approves the completion of the whole clinical trial, not only for researchers and subjects, but also for ethics committee members. The ethics committee is equivalent to a supervisory organization for the protection of subjects’ rights and interests. It mainly examines the qualifications, work experience and scientificity of the trial scheme of researchers and applicants. 3. The principle of autonomy in the process of participating in clinical trials, whether due to adverse reactions or other reasons of their own. As long as they are no longer willing to continue clinical trials, they can withdraw at any time. Moreover, the State has relevant laws and regulations, after the subjects withdraw, hospitals, researchers and doctors shall not discriminate against the subjects. 4. Medical convenience in order to facilitate researchers to observe the changes of the subject’s body more directly and clearly, the subject may receive more care from the medical process than ordinary patients, such as: the convenience of seeing a doctor; In addition, not only are the examination and treatment fees of the subjects free of charge during the whole trial process, but also the compensation principles adopted for the subjects are designed in advance and recorded in the informed consent form once the patients have adverse reactions during the trial? Clinical trials, It represents the latest treatment direction for a certain disease. And the correctness of this direction, It has been rigorously demonstrated in vitro. For clinical trials of tumor drugs, The patient participates, which is to increase the hope of curing the disease for himself. Once the clinical trial is successful, The patients who participated in the experiment, Will be the first beneficiaries. For clinical trials of drugs for other diseases, Participating patients can be more closely observed and cared for by doctors. Doctors will follow up until the disease is cured or controlled. What’s more, many [new] drugs in China have actually been recognized as safe and effective by other countries. In order to meet Chinese standards, they must be re-tested in China, so what is not regarded as a [mouse] at all. How participates in clinical trials? There are two main ways to participate: the recommendation of the doctor the subject visited; As well as recruitment advertisements from various hospitals or regular research institutions. Suggestions before deciding to participate in clinical trials: 1. Confirm the trial qualification before participating in clinical trials, confirm that your doctor or recruiter has the trial qualification (must have the qualification certificate of practicing doctor, practicing post certificate and GCP qualification certificate at the same time), and confirm that the recruiting hospital has the trial qualification (check website: http://recruit.druggcp.net/); 2. Fully understand and communicate as a subject, you should fully understand the test plan, possible adverse reactions, rights and interests protection and other contents of the clinical trial you want to participate in. If you have any questions, you must communicate with the researchers in time without leaving any dead corners of the problem. 3. Self-assessment While the researcher evaluates the physical condition of the subject, as the subject, he should evaluate his own condition to make clear whether the whole test process will have serious conflicts with your daily life, study and work, so as to avoid the failure of the test due to such conflicts. Clinical trials are not scourges. The subjects are not mice. In formal institutions, participating in clinical trials in the right way can not only play a role in treating patients’ diseases and prolonging the life span of patients, but also contribute to the development of medical and health undertakings.