In the field of medicine, every breakthrough discovery and innovation is the result of the joint efforts of countless medical experts, researchers and volunteers participating in clinical trials. Patients are the promoters of medical research and the explorers who start the journey of health revolution. Why do doctors refer patients to clinical trials? What are the pros and cons of participating in a clinical trial? Can all patients participate?
What is a clinical trial?
Although the effectiveness and safety of new treatments that are
not yet on the market have been confirmed by animal tests (pre-clinical studies), in view of the differences between humans and animals, further human tests (clinical trials) are needed to confirm their safety and effectiveness, so as to find the best way to prevent, diagnose and treat diseases. Clinical trial is a formal scientific process that all new drugs must go through before they are marketed, and it is carried out under the requirements of national laws and regulations such as the Drug Administration Law of the People’s Republic of China, the Measures for the Administration of Drug Registration, and the Good Clinical Practice for Drug Trials. Only when a new drug is proved to be safe and effective for patients, can it be approved by the National Medical Products Administration for marketing.
A
clinical trial is a method of scientific research designed to evaluate the safety and efficacy of a new medical strategy, treatment, or drug. These experiments provide a reliable data base for medical research through rigorous scientific design.
Benefits
of
participating in clinical trials
(1) To obtain advanced treatment, all effective new anti-cancer drugs need to undergo lengthy clinical trials before they are approved for marketing. China’s drug regulatory authorities stipulate that internationally marketed drugs still need to complete clinical studies in China before they can be approved for marketing, which makes the time for Chinese cancer patients to use new drugs several years later than patients in Europe and the United States. For cancer patients, time is life. At present, many clinical trials carried out in China are new drugs whose efficacy has been confirmed abroad. By participating in the clinical research of such new drugs, patients can experience the most advanced treatment programs abroad free of charge for the first time. For example, some patients have participated in clinical trials of new drugs for specific types of tumors and achieved better results than traditional treatments, not only the tumors have been effectively controlled, but also the quality of life has been greatly improved. According to statistics, about [X] percent of patients have been improved to varying degrees after participating in such clinical trials.
(2) Reducing the economic burden In most clinical trials, the “standard treatment drugs” whose efficacy has been confirmed are often compared with the “experimental drugs”. Whether patients enter the experimental group or the control group, they can get effective treatment, and the drugs are provided free of charge. Some clinical trials also provide free blood, imaging and follow-up services. This is undoubtedly a timely help for the families of patients with financial difficulties. Taking a patient with advanced lung cancer as an example, after participating in clinical trials, he saved hundreds of thousands of yuan in treatment costs, greatly reducing the family’s economic pressure.
(3) Most of the researchers who enjoy meticulous care and preside over the clinical research of new cancer drugs are authoritative experts in the field of cancer. Participating in clinical trials under his auspices means that patients can receive comprehensive and meticulous care and care from the clinical team led by him. The expert team will pay close attention to the changes of the patient’s condition and adjust the treatment plan in time. At the same time, the study nurse will follow up the patients regularly to ensure the safety and comfort of the patients during the trial.
(4) To understand the progress of treatment, patients participating in clinical trials can fully understand the current international treatment level and the latest progress of their disease, as well as the relevant information on the prognosis of the disease from doctors. Patients can “know each other” and better cooperate with doctors in the treatment of diseases. For example, after participating in clinical trials, a breast cancer patient learned about the latest treatment methods and drug research and development trends, and was full of confidence in his treatment.
Is it safe
to participate in clinical trials?
1. This is the biggest question for all patients. In this regard, we can answer responsibly that participating in clinical trials is by no means a “guinea pig”. Before clinical trials, a series of preclinical basic studies are needed, including cell and animal experiments. Combined with the medication data of animal experiments, including safety and effectiveness, after careful clinical trial program design, submitted to the State Drug Administration for review, can be applied for in various medical institutions. Before the specific implementation, following the principles of ethics and science, it is necessary to pass the review of the local ethics committee, which judges whether the risk-benefit ratio of the clinical trial is reasonable and whether the protection of the rights and interests of the subjects is adequate. Only clinical trials that have passed the ethical and scientific review can be carried out in medical institutions, otherwise the trial can not be carried out by the ethics committee.
2. The treatment plan adopted in clinical trials is usually the most advanced treatment method at present. The hospitals and departments that can conduct clinical trials generally have strong comprehensive strength, and the process of implementing clinical trials is also strictly supervised by the national drug supervision and administration departments at all levels. Finally, throughout the clinical trial, patients will receive more attention than ordinary patients, not only the medical services of the attending physician, but also the care and full service of more professionals (such as pharmacists, research coordinators). They can contact the ethics committee of participating medical institutions for help, and the ethics committee will pay close attention to new information and new situations in clinical trials at any time, and take corresponding measures to maximize the safety of subjects. And the informed consent is not a contract, representing the patient’s understanding of the clinical study and informed consent. Participants can withdraw from the clinical trial at any time without affecting their normal medical treatment.
3. To sum up, the subjects are definitely not “white mice”. Participating in clinical trials in the right way in regular experimental institutions may not only treat patients’diseases and prolong their lives, but also contribute to the development of medical and health undertakings.
How to participate in clinical trials?
If you want to sign up for clinical trials, you often need to consult in the outpatient clinic of related diseases, whether there is an ongoing clinical trial suitable for you, or pay attention to the announcement information of “subject recruitment” on the hospital website. When applying, patients should bring all the medical data, including past outpatient and inpatient treatment records and medical records, pathological data, treatment plans, examination and test results, etc. The investigator will screen you according to the clinical trial project under research. If the screening is suitable, the investigator will fully communicate with you and explain in detail, sign the informed consent, and follow the procedures of the clinical trial for examination, treatment and follow-up.
Secondary malignant neoplasms of other specified sites Malignant neoplasm of unspecified site
