Chapter 178: Clinical trials are required
The clinical problems mentioned by Xiao Ming are actually the final stage of testing the experimental results.
The technology is successful in theory, but it cannot be proven that it will be successful in the clinic.
It is still relatively difficult to conduct clinical experiments in Xia Kingdom!
In addition to the complicated procedures, it is also a question mark whether the cooperation of the hospital can be obtained.
Moreover, in the field of medicine, clinical trials not only involve medical technology issues, but also involve patients' life safety and ethical issues.
After all, Pangu Technology's life science laboratory belongs to a private research institute of private enterprises, and in the field of life science research, most of the keys are in the hands of the state, in the hands of Yenching University, Jiangcheng University and other university research institutions.
When Xiao Ming mentioned the clinical problem, Gao Siqi also fell into deep thought.
"We don't have a specialized hospital, and we don't even have the qualifications for clinical trials," she said. ”
"If you apply now, how long will it take?" Xiao Ming said after thinking for a while.
Xiao Ming is not an expert in medical experiments, so he asked this question.
Zheng Xuanyu is an expert in this area, saying: "If you have a hospital background or a scientific research institution that cooperates with the hospital, the time is a little faster, and the application is as short as three to five years, and as long as ten to twenty years, which is the case in Xia and Mi. After all, a new drug and a new treatment must be absolutely safe from the success of the experiment to the market. But what you ...... now."
Zheng Xuanyu said: "Now it is obviously impossible, drugs or treatment methods before entering the clinical trial there is an analysis report, followed by a complete animal medical experiment, and finally human clinical experiments, human clinical trials have four stages, this process is quite long." ”
Zheng Xuanyu took the anti-cancer targeted drugs of the United States as an example and said: "Now we see on the market that the latest anti-cancer drugs in the United States were actually established more than ten or twenty years ago! The same is true in the Xia Kingdom, ordinary drugs take at least three or four years from research and development to marketing, and drugs related to the life safety of patients such as anti-cancer drugs are also running for ten years!"
Xiao Ming knew that this was a law and a regulation, but he also expressed serious incomprehension.
Taking patients with advanced cancer as an example, they are all already in the terminal stage of cancer, and they are all counting their fingers to live, if there is really a special drug, it is too late to take it immediately, where is there any worry about the danger of life safety?
The premise here is that the drug actually works!
Xiao Ming said speechlessly: "Ten to twenty years of marketing approval, such a long time, I don't know how many patients have no chance to wait." ”
Gao Siqi also sighed.
Xiao Ming felt a little funny at this time, the laboratory of gene expression regulation was completed in full accordance with the experimental guidelines of Pansar Technology, and the results were expected, and it was definitely able to treat cancer.
A method that has long been proven to have no side effects at all has to go through a lengthy approval process here, which is indeed a bit of a drama.
But this is also normal, Xiao Ming can't always hold the treatment plan to the relevant departments and say, there is absolutely no problem with this technology, you have to believe me.
Zheng Xuanyu put forward a feasible plan, she said: "We have two plans, one is to follow the usual steps to apply for a clinical trial license and wait for the approval of the relevant departments. Another option is to work with hospitals to recruit patients who voluntarily try new drugs, but the latter is riskier. ”
"What does the last plan mean, can you be specific? Gao Siqi asked.
Zheng Xuanyu nodded and said: "In fact, not only in Xia Country, but also in the United States, many of the most advanced anti-cancer drugs have not completed the procedures, or they are still lacking, and they have not obtained marketing authorization. The market refers to these drugs as defective drugs. However, there is a strong demand for these imperfect drugs. ”
Zheng Xuanyu continued to take the most advanced and complete cancer medical technology in the United States as an example: "Many research institutions in the United States cooperate with hospitals to provide patients with 'defective' drugs, which can alleviate the pain of patients and prolong the life of patients even if they are defective. People are on the verge of death, and they can be regarded as dead horses as live horse doctors. ”
Gao Siqi said: "You're talking about the country of rice, this is the country of Xia, is it okay to do this?"
Before Zheng Xuanyu could answer this question, Gong Luyue interjected and said: "There are more defective drugs in Xia Guo, what folk anti-cancer secret recipes, what traditional Chinese medicine methods, etc., which of these folk Chinese medicine and prescriptions has been approved? ”
Gong Luyue inadvertently said the darkest and most absurd side of Xia Guo Medical, she said that these patients are definitely not a few, most of them chose to believe in the so-called folk traditional prescription for conservative treatment after being incurred in a big hospital, and the final outcome of these patients is death.
Therefore, what approval, what clinical trials are empty words.
After Gong Luyue's speech was published, Xiao Ming also felt deeply helpless.
Zheng Xuanyu continued: "Just now I took the country of rice as an example, in fact, the same is true of the country of Xia. Many universities, official and non-official scientific research institutions have cooperated with hospitals to market defective drug treatments to patients. These drugs are not approved for marketing, and they are all in experiments. However, the drugs are more or less effective and can prolong the survival expectation of patients. ”
"In the treatment process of using defective drugs, the hospital only acts as an intermediate platform and does not make any guarantees to the patient, while the pharmaceutical company signs an agreement with the patient and does not guarantee the survival rate of the patient. However, all of them have terminal cancer, and people are dying, and many patients still try new drugs that have not been marketed with the mentality of giving it a go. This approach gives patients a chance to survive and gives pharmaceutical companies the opportunity for informal clinical research. After all, from the perspective of medical experiments, the time and money spent on formal clinical medical experiments are quite huge, and few companies can afford them. ”
Zheng Xuanyu is worthy of being an expert, she has a very thorough understanding of medical experiments, "If these informal clinical experiments are proven to be effective, then the medical laboratory will apply for superior funds to continue the research with sufficient data, or simply monopolize the experimental project to more professional and powerful pharmaceutical companies, and these pharmaceutical companies will go through complex procedures such as clinical trials and approvals, which is the status quo of global medical research." ”
"So, it's up to you how you decide" Zheng Xuanyu looked at Xiao Ming.
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