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Local：Home-> Company They are volunteers and unsung heroes!
Time：2020-08-17Click：
A new drug, from the laboratory to the market, must go through a healthy human trial process, which is called phase I clinical trial. What kind of environment were these healthy volunteers in? Is there any "danger" in the process of testing? What are the related procedures after the trial? Recently, our reporter walked into the Clinical trial center of Beijing hospital and opened the trial procedure full of mysterious color.
Only a hundred hospitals can do a trial
In one of Beijing hospital's wards, an office block on the first floor that must be opened with an access card is the newly opened Beijing Hospital Clinical Trial Center. On entering the clinical trial centre, it looks at first glance like most scientific institutions: there are bottles and cans in the laboratory, and large, double-circuit-powered cryogenic refrigerators in the herbarium... But it is different from a normal scientific institution, because there are also 24 hospital beds. But the people who come here to be hospitalized are not patients, but healthy people, and they are "drug testers."
"When a drug moves from the laboratory to the clinic, it has to pass through a healthy population." Li Kexin, director of the Beijing Hospital's clinical trial center, said that after a new drug has been tested in the laboratory for its pharmacology and toxicology, animal tests must be carried out on two or more animals. Of these two animals, one is a rodent, most commonly known as a "rat"; In addition, it is necessary to conduct animal experiments on animals that are close to humans, commonly used to include rabbits, dogs, monkeys and so on. "If you do an experiment with a monkey, you don't just buy a monkey and go through the process. You go to a special animal breeding base and select those animals that meet national standards." Once animal tests show that the drug is safe and effective, clinical trials, known as "human trials," are needed. Among them, phase I clinical trials were conducted in healthy people. The Beijing Hospital is one of only more than 100 medical institutions in China capable of carrying out phase I clinical trials.
Less than 20% of the volunteers passed the physical examination
In China, a new drug goes through phase III clinical trials before it is marketed. Phase I trials are usually conducted in healthy people, while phase II and III trials are conducted in patients who meet the indications for the new drug. "This means that people who are in phase TWO or three are likely to benefit from the trial, whereas people who are in phase one may not benefit at all, and therefore deserve more respect." Most new drugs will be tested in phase I trials in healthy people, Dr. Li said. Through a phase of the test, can understand the reaction of unlisted new drug in the body, the researchers will pass the test subjects blood, urine, feces samples, such as understanding of drug in the body's absorption, distribution, metabolism and excretion, "it can be said that many of the items on your leaflet is through a phase of clinical trial."
In the Clinical trial research center of Beijing Hospital, the largest room is the volunteer activity room. All volunteers who come here need to have an informed consent conversation. "Every volunteer has the right to know and make decisions, and can withdraw from the trial at any time and without conditions." 'The specific content of the informed consent includes the name of the drug to be tested, the method of administration, the test process and visit plan, potential risks, adverse reactions, expected benefits and sample collection plan,' Mr. Li said. Not everyone who is determined to come here for a clinical trial can meet the requirements of the trial. "After the initial physical examination, about 80 percent will be eliminated," he said. In a recent clinical trial, there were more than 50 volunteers and fewer than 10 qualified."
Many people think they are healthy, but testing for new drugs requires more of a healthy population, and different drugs have different requirements. Li said the Beijing hospital had conducted a phase I clinical trial of a new drug that required volunteers to comply with a total smoking ban because of concerns about tobacco's effect on drug metabolism. "Every volunteer who comes in for an experience has to have the nicotine content of their urine measured to see if they are a smoke-free volunteer." Some of the volunteers were non-smokers themselves, but also failed to pass the test after being exposed to a lot of second-hand smoke. Some new drugs may have adverse effects on the fundus, so the volunteers participating in the trial are required to have good fundus health. This standard can also eliminate many volunteers who look very "healthy". Of course, there have been some "weird" volunteers, such as those who showed up with other people's ID CARDS and had urine samples strapped to their thighs. "For these volunteers, our attitude is no!"
In case of adverse reaction, rescue at any time
After passing a medical exam, volunteers can be enrolled in a new drug trial, usually admitted to the hospital the day before the trial is launched, and then given a series of tests. Then he was admitted to the lab ward, put on a wristband, given a packet number, and administered the drug the next day. During their stay in the hospital, their diet and water intake were fixed on a regular basis, so as not to affect the relevant data on drug metabolism. After the drug is administered, the nurse will also collect blood, urine and stool samples at different points in time. In some tests, blood samples will be collected more than 10 times a day.
The reporter noticed that in the clinical trial research center, there is also a rescue room, which put the rescue car, ventilator, electrocardiogram machine, defibrillation apparatus, ecg monitoring machine and so on. "Once there are volunteers in various situations, here can be rescued at any time." The emergency room is not "just a decoration," Mr. Li said. "If you look at this emergency car, there are different kinds of emergency medicines stored in different layers. These medicines need to be checked and replaced regularly to ensure that they are used within their validity period." Li remembers the scene: "At that time, he was sitting on a swivel chair. The needle the nurse used to draw blood had just stuck in, and the volunteer fainted. The nurse pushed the swivel chair and sent him to the emergency room." The doctors and nurses started the emergency treatment, and soon the volunteer woke up. "What's going on? Why am I lying here! '
Say not nervous? That's not true!
Currently, most clinical trial centers entrust recruitment companies to recruit healthy volunteers. Some of the volunteers are medical college students. Researchers were able to communicate more easily with medical school students than with other volunteers, who were relatively healthy, though some of them failed medical tests. Xiao Yang, a graduate student in pharmacy, once participated in an experiment. "I went to the clinical trial with a classmate, and I was nervous even though my classmate repeatedly told me it was safer." Xiao Yang said that he was a pharmaceutical student, from a professional point of view, but also to understand the process of new drug testing, so decided to participate in the trial. To the scene, Xiao Yang carried out a series of inspections; The next day, the results came out, she failed, "this feeling, both a little relaxed, but also a little regret."
Li kexin said that in recent years, China's new drug phase I clinical trials have become more and more standardized, and the current state food and drug regulatory authorities for new drug testing management is becoming more and more stringent. The clinical trial research center of The Beijing Hospital is equipped with advanced equipment. For example, the refrigerators that store blood and urine samples of volunteers are all medical refrigerators with the temperature as low as minus 80 degrees Celsius. All the samples are in two copies and placed in different refrigerators. In this case, even if one refrigerator fails, the other refrigerator can still provide qualified samples; In the laboratory, there are refrigerators and drug cabinets with different storage conditions. Some drugs need to be kept in a constant temperature and humidity environment. There is also a constant temperature and humidity cabinet like a safe, where the internal humidity and temperature are displayed on the cabinet door at a clear sight...
The most important thing for the phase I trial is to ensure the safety of the volunteers, and all trial designs must be approved by the ETHICS committee. Although the new drugs entering phase I trials have been tested in laboratories and animals, They are not absolutely safe, Dr. Li said. A trial of the new drug in The UK in 2007 had such a bad reaction that the immune systems of six volunteers were destroyed. "Behind every new drug coming to market, there are so many people taking risks to try it, volunteers and unsung heroes."
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Drug clinical trial
Divided into four period
China clearly stipulates that the application for registration of new drugs shall be subject to clinical trials. Clinical trials of drugs are divided into phase I, II, III and IV.
Phase I clinical trial: preliminary clinical pharmacology and human safety evaluation trial. To observe the tolerance degree and pharmacokinetics of new drugs to provide the basis for the formulation of drug delivery plan.
Phase II clinical trial: preliminary evaluation of therapeutic effects. The objective is to preliminarily evaluate the efficacy and safety of the drug in patients with the target indications, as well as to provide evidence for the design of phase III clinical trial study and the determination of dose regimen. Study design at this stage can take a variety of forms, including randomized, blind, controlled clinical trials, according to specific study objectives.
Phase III clinical trial: Confirmation of therapeutic effect. Its purpose is to further verify the therapeutic effect and safety of the drug on the target patients with indications, evaluate the relationship between benefits and risks, and finally provide sufficient basis for the review of drug registration application. Trials should generally be randomized blind controlled trials with sufficient sample sizes.
Phase IV clinical trial: the stage of applied research after the new drug is marketed. The purpose of this study is to investigate the efficacy and adverse reactions of drugs under widely used conditions, to evaluate the relationship between benefits and risks in general or special populations, and to improve the dose of drugs administered.
Bioequivalence test refers to a human test in which pharmacokinetic parameters are taken as indicators to compare the same or different dosage forms of the same drug with the method of bioavailability study. Under the same test conditions, there are statistical differences in the absorption degree and speed of the active ingredients.