With the progress of medicine, more and more clinicians and patients are exposed to the term “clinical trial” more and more frequently. Perhaps it is the history and culture, especially the difficult history of the modern nation, that has given us a special cultural background to the word “trial”. Therefore, it is necessary to elaborate on the term “clinical trial” with the simple purpose of improving the rational understanding of patients and their ability to make appropriate choices when faced with such situations. In this article, we will briefly explain the necessity, rationality, benefits and risks of clinical trials, and finally, we will briefly explain the considerations for participating in clinical trials. The necessity of Fu Bin, Department of Hematology, Xiangya Hospital of Central South University Since ancient times, any knowledge needs long-term accumulation, and medical knowledge especially needs a lot of long-term observation and testing in the process of fighting with diseases. In the case of people with diseases, any other experimental studies other than human beings cannot show that it will also work wonders in human beings, which are special and unique animals, so it is not enough to extrapolate to human beings except for the knowledge obtained directly from human beings. This is what makes medicine special. The development of medicine also follows the development of individual experience —- expanded experience —- widespread application —– standardized treatment. It is a spiral progression of practice to theory to practice. In this regard, the developmental journey of TCM has demonstrated the strong power of empirical medicine. However, the ever-changing trend of changing disease types, expanding individual differences, and constantly updated therapeutic drugs, among other changes, makes it difficult to adapt the pace of progress begun by individual experience to the changing needs of solving medical problems. Modern medicine tries to make the process of accumulating such experience more standardized and scientific, thus clinical trials, a method of accumulating modern medical knowledge, are gradually gaining worldwide recognition, and the standardized treatment arrangements for many common diseases at home and abroad are based on the knowledge derived from these planned rational and scientific clinical trials, which directly affect people’s daily life and treatment choices: for example, elderly people should prophylactically For example, elderly people should be treated with aspirin anticoagulation to prevent cardiovascular disease, low-risk AML patients do not necessarily need to undergo HSCT after remission while high-risk AML patients should undergo HSCT after remission, acute lymphoblastic leukemia patients should undergo HSCT even after their first remission, promyelocytic leukemia induction therapy should use retinoic acid, arsenic The induction therapy for promyelocytic leukemia should be with retinoic acid, arsenic and anthracycline antibiotics, and after remission, consolidation therapy and maintenance therapy should be continued. Therefore, without clinical trials, modern medicine would not have developed so rapidly, and more patients would not have benefited from it. Beneficence If the above necessity is the contribution of clinical trials to the population as a whole, then it seems that we should be more concerned about what clinical trials mean to a specific patient when faced with a live patient. For example, in the case of a patient with multiple myeloma, the diagnosis is clear based on the patient’s clinical manifestations and laboratory tests, and then a treatment regimen with definite efficacy, such as Vanco (bortezomib), is used according to the treatment protocols obtained through clinical trials, and the disease progression is initially controlled and remission is achieved or the condition improves, but as time goes by, the patient again develops bone pain and anemia, and tests reveal that monoclonal globulin is again In short, the patient experienced a relapse. What are the patient’s treatment options? To use Vanco again? Use a stem cell transplant? No physical or financial conditions! Induction therapy regimen? Cannot significantly delay progression! Second-line chemotherapy regimen? No significant delay in disease progression and side effects of intensive therapy may not be tolerated! As the patient’s primary care physician, I would like to choose a treatment option that is both safe and likely to be effective, but there appear to be few good options. Previous small trials have shown that ralidomide is better for refractory and relapsed multiple myeloma than other options currently available, and then larger, more scientific clinical studies need to be organized to validate this experience. Such experimental studies have been done and the results show that indeed, ralidomide is more effective and well tolerated with fewer side effects. But such studies have been done in foreigners, can they be used in the Chinese? Can relapsed and refractory Chinese patients get better with this drug? Then we need to have information from Chinese patients. So this trial was moved from abroad to China. That’s the background of how the clinical trial of ralidomide came about. Well, that gives us a rational basis for this trial: we’re dealing with patients who are difficult to treat, we’re faced with the challenge of how to improve outcomes, and the available information suggests that relidomide might benefit the patients in front of us, so we organized this trial. We offered the patient to be considered for this trial because, on an individual basis, ralidomide might improve his condition. And the drug is provided free of charge, a cost that is equivalent to the cost of a hematopoietic stem cell transplant. Risks Although it is mentioned above that a particular patient may benefit from a trial, a clinical trial should never be considered as one of the treatment options. Obviously, the information on the effectiveness of ralidomide comes from foreigners, and although the ethnic differences may not be significant, after all, there is no information on Chinese people, and there is no guarantee that the effectiveness of this drug will increase after taking it. Are the toxic side effects also high, and are the patients part of the unfortunate group of people who experience toxic side effects? This is the risk. There are no absolutely effective treatments in the medical field, and a treatment with high efficiency is not necessarily effective for the individual patient in front of you, and a treatment with low efficiency is not necessarily ineffective for the patient in front of you. Therefore, physicians cannot intentionally avoid risk and cannot use the effectiveness of a treatment as “bait” to persuade a patient to enter a clinical trial. The decision to enter a clinical trial needs to be made by the patient’s own values. What physicians need to do is to give informed consent. The focus should not be on the benefits of participating in a clinical trial, but rather on the risks involved, so that patients can consider carefully whether to participate. Points that should be clear before participating in the trial Detailed information about my condition and the trial content is needed: where my condition is, what are my treatment options, what are the chances of being effective, what is the basis for the trial drug to be used for my condition, whether the clinical trial is approved and supervised; what side effects may occur and how to handle them; whether the patient can be unconditionally pushed out of the trial at any time; whether the trial can be continued after the trial ends The drug; what obligations need to be fulfilled.