This doctor has a system

Chapter 368 434. To conduct clinical trials abroad

Ensure the animal is securely secured and align the needle along the midline of the spine.

Insert the needle gently vertically (or slightly tilted 70-80°) into the intersection of the indentations, keeping the syringe vertical. When the bone is touched, slowly reduce the angle to about 30° and slide the needle into the intervertebral space.

If the mouse has an obvious sudden tail flick, it is a sign of successful insertion into the intervertebral space. The needle will feel firmly clamped once it enters the intervertebral space.

At this time, you can start injecting.

Hu Jiaran tried it and felt that it was okay, but others were slow to get started, and this operation was indeed a bit difficult for them.

After some discussion, Hu Jiaran asked someone to buy a second-hand X-ray machine to facilitate everyone's practice. In the early stage, fluoroscopy can be used to determine the injection site.

I have to say that this method still has merit. The mice are anesthetized with fentanyl and then punctured. After the puncture, X-rays are taken to determine the success rate of the puncture. It is very suitable for newcomers to practice.

I don’t know how many mice died this week.

"How is it? Are the results out?" Hu Jiaran asked immediately when he saw Yue Penghui coming over.

"The specific results will not be available until tomorrow." Yue Penghui said.

Hu Jiaran shook his head. He had already tried it, but it didn't work.

"They have a great background." A colleague laughed, "Do you know ECMO? The domestic ECMO equipment is produced by them."

After the problem was exposed, the authorities have recently tightened the application for approval of drug clinical trials, which is equivalent to saying that they are lying on their hands.

Recently, an upcoming clinical trial has caused quite a stir in the country.

Director Zhou Tianli has never felt any sense of honor for his profession. He is engaged in spinal muscular atrophy.

"I forgot my cup here."

"What else can we do? Make the animal experiments more perfect and wait for a while before submitting the application." Hu Jiaran sighed.

Hu Jiaran was overjoyed and quickly called Gao Feng to report the situation.

"Then what are you doing here?" Hu Jiaran was a little dissatisfied.

脊髓性肌萎缩症（SMA），是定位于染色体5q13.2的运动神经元存活1（SMN1）基因突变，所致的常染色体隐性遗传病，比较罕见，发病率为 1/10000～1/6000，携带率为 1/50～1/40。

"Let's add more detailed data and conduct another large-sample trial."

It can be said that once the disease is diagnosed, it means cruel consequences. As the top hospital in China, Beijing Union Medical College Hospital does not know how many patients with the disease it has admitted and diagnosed.

He came to the laboratory early the next morning. Dr. Lu was leading people to tally the results. They worked all night and finally tested most of the mice.

"Yes." Hu Jiaran said with a worried look on his face, "It is said that there are flaws in animal experiments and insufficient evidence-based medical evidence."

"How is it? Are there any changes in the values ​​before and after?"

Yue Penghui picked up the cup and ran away. Mr. Hu may have been under a lot of pressure recently. His uncle is here and his temper is very unstable. He has been scolded several times in the past few days.

SMA type II (late-onset infantile type): onset 6 to 18 months after birth; normal sucking and swallowing functions in infancy, no dyspnea; can sit alone, but never able to walk independently; can survive to 10 to 20 years old, and often dies. Paralysis of respiratory muscles.

Zhou Tianli will write down the name and contact information of each diagnosed patient and conduct a follow-up telephone visit once a year. So far, there are 86 names in his notebook, and 61 have been crossed out.

"The inclusion of exon 2 in the intrathecal SMN7 messenger ribonucleic acid (mRNA) transcript also significantly exceeded the original value."

"No reply?"

After a drug entered clinical trials last year, subjects experienced serious adverse reactions. Investigators found that the drug’s animal testing was suspected of falsely reporting data and artificially shortening the testing period.

"Are you here to work or to drink water?" Hu Jiaran glared at him, "Drink, drink, drink, you know how to drink every day!"

"What is the origin of Fengxin Technology?" Zhou Tianli asked the people around him, "I am familiar with all the large medical companies in China, but I seem to have never heard of this name."

At present, there are no specific therapeutic drugs at home and abroad, and symptomatic treatment has always been the main approach.

Logically speaking, since it is an orphan drug, the clinical trial approval of Nosinaxin Sodium should be carried out quickly. However, since the subjects of clinical trials are almost all children, problems have arisen in some aspects.

SMA type III (juvenile type): onset 18 months after birth; normal in infancy, slowly worsening generalized muscle weakness and heavy proximal limbs between 5 and 15 years of age; able to walk independently within a certain period of time, and can survive until middle age , lose the ability to stand alone after the age of 30, and often die from respiratory muscle paralysis or systemic failure.

Gao Feng was also a little helpless, but he didn't seem to have any special solution. Academician Bao can certainly speak his mind, but Gao Feng felt that it was not appropriate for him to take the lead at this point.

"Yes, the changes are quite obvious." Dr. Lu quickly reported, "The value of SMN protein in the cerebrospinal fluid of mice increased significantly after the injection of the substrate."

Hu Jiaran was indeed a little stressed. Gao Feng asked several times about the situation here. Although he did not mean to rush him in his words, it was obvious that the boss was very concerned about the progress of the experiment.

Gao Feng was a little worried now. He got more news. In fact, they were implicated this time.

However, what Gao Feng is currently working on has little to do with pediatrics. The professions are separated by mountains, and the professional barriers in clinical departments are deep. It is normal for Zhou Tianli to be unclear about it.

SMA type I (severe infant form): onset within 6 months after birth; severe cases have obvious symptoms at birth, including weakness of limbs, difficulty in feeding, and difficulty in breathing; they are never able to sit independently, and the prognosis is poor, and death occurs before the age of 2 years.

For a time, relevant people in the medical field were talking a lot.

When he received the notice of the clinical trial of Nosinasen Sodium, he was happy at first, but then a little disbelieving.

"And that bevacizumab, there seems to be something else."

The cause of the matter is very simple. The Department of Pediatric Neurology of Beijing Union Medical College Hospital issued a recruitment notice. The article stated that a new drug will soon undergo clinical trials in the hospital, and the subjects of the experiment will be patients with 5q spinal muscular atrophy.

"Can you find someone to talk to you? There must be no problem with our security." Dr. Lu was very anxious.

Every time he was diagnosed with the disease, he felt helpless. The family members will first be happy that the cause of the disease can be clarified, and then they will fall into despair under his explanation.

Many people are not very interested in receiving information that is less relevant to them.

"What should I do?"

This is exactly the situation. The person who approves the reply is not necessarily a professional. On the contrary, professionals have no right in this regard.

Just when everyone was at a loss, someone suddenly came to the door.

"Mr. Marshall, I'm afraid I have to disappoint you." Director Zhou Tianli of Beijing Union Medical College Hospital said, "We have not received approval for clinical trials, and we are currently unable to conduct them."

Maurice Marshall, who comes from the Danish royal family, has always felt that he is very lucky. Others have all roads leading to Rome. He was born in Rome.

His wife and he were playing music together, and they were in high spirits when their 8-month-old son was suddenly diagnosed with spinal muscular atrophy. At the beginning, Maurice Marshall was not particularly worried. It was just an illness and would be cured, and he was not short of money.

But soon, the doctor's words caused his expression to change drastically.

"That means I can only watch him die, right?!!"

The doctor understood his anger, but could only shake his head to express his helplessness.

The wife suddenly collapsed and cried all day long.

"Marshall, there's a good chance our child won't live to be two years old."

Maurice Marshall felt a pain in his heart after hearing this. The Danish royal family still has a great influence in Europe. He contacted many pediatric experts.

But the feedback is always disappointing.

But just some time ago, a professor he had contacted before told him that the distant country of China seemed to be launching a clinical trial, and the test subjects were patients with spinal muscular atrophy.

At this time, Morris Marshall seemed to have grasped a life-saving straw. He took his children to the capital as quickly as possible with the idea of ​​​​serving a dead horse as a living horse doctor.

"No approval?" Marshall felt cold in his heart, "Why? Is there any difficulty?"

At that moment, Director Zhou told him the specific situation.

“Then is it okay if we voluntarily conduct this clinical trial?”

"I'm afraid not. This is obviously against the laws of our country." Director Zhou shook his head.

"However, a big man like you must have other ways." He said at the end.

Marshall thought, yes, laws are also made by humans. Since it is formulated by humans, it can be modified by humans.

"So, you mean we can go to Denmark for clinical trials?" Hu Jiaran said in somewhat broken English.

"Yes, I can use my influence to help you avoid legal problems." Marshall said confidently, "At least there will be no obstacles in Denmark."

"Wait a moment, our boss will be here soon." Hu Jiaran said, "He has the final decision-making power."

"The Danish royal family?"

"Yes, this Maurice Marshall is still a relatively early royal heir." Li Youliang smiled, "Denmark is a monarchy and is said to have a history of more than a thousand years."

Gao Feng smiled when he heard this. Just listen to this history and stuff. Anyway, it's all his own bragging. Moreover, it is only over a thousand years old, which is obviously a little shorter than that of China.

"Hello, Professor Gao." Marshall placed himself in a very upright position without any airs of an ancient nobleman, which gave Gao Feng a good initial impression of him.

The two chatted for a few words at first, and Marshall quickly got to the point.

"Professor Gao, I invite your team to go to Denmark to conduct clinical trials for spinal muscular atrophy." He said solemnly, "My son who is more than eight months old has been diagnosed with this disease. He has been seeking medical treatment for more than two months. Asking for medicine made me exhausted and I had given up, but I heard "

"I'm afraid this is not appropriate." Gao Feng thought for a moment and said, "Our preliminary animal experiments were conducted in China and were not registered with the FDA. Conducting clinical trials in Denmark is not in compliance with the law."

"I'll take care of the legal issues." Marshall said quickly.

"I'm afraid this won't work," Gao Feng said. "Even if conducting clinical trials in Denmark can avoid legal issues, the results of the clinical trials may not be recognized by European countries."

"If our drugs can neither be marketed domestically nor be approved in European countries in the future, the significance of clinical trials will be lost."

Marshall's face turned pale. He had no way to refute Gao Feng's words. It was because Denmark was too small.

"Mr. Marshall, you might as well wait a little longer. We will prepare to submit the application again after a while." Hu Jiaran said at the side, "The probability of passing is very high."

"But my son's condition is very bad now. He is currently on a ventilator." Marshall said dejectedly. "He has been suffering from pneumonia, and the doctor said that his condition continues to get worse."

"Please save him." He suddenly grabbed Gao Feng's hand, "I really can't imagine the consequences of losing him."

Gao Feng was really in a dilemma now. The key was that he had never considered conducting clinical trials abroad before.

Not to mention legal issues, people who are unfamiliar with the place there may be beyond their reach if something goes wrong.

Moreover, although this Marshall is sincere now, if something goes wrong in the clinical trial, will there be another face by then?

He was most afraid of trouble, so he had no choice but to refuse.

Marshall left disappointed.

Gao Feng thought the matter was over, but within a few days someone came to the door again, accompanied by former Dean Qin, who is now Secretary Qin of the Health Commission.

"Professor Gao, we are from the Foreign Affairs Office." The visitor showed Gao Feng his ID and said, "I have something to do with you."

Outside the door, Dean Guo was very nervous.

"Old leader, Gao Feng is this"

"Don't worry, it's actually not a bad thing." Secretary Qin smiled, "Gao Feng in our hospital is really capable, and his reputation has spread abroad."

"Denmark has sent a formal letter." The person from the Foreign Affairs Office said to Gao Feng, "The leaders have also discussed this matter."

"Don't feel pressured. The Danish Embassy can always get involved if necessary."

"Can you think about it?"

Everyone said so, and Gao Feng immediately agreed. The opinions of the leaders are already very clear. They are just being polite to ask you to consider it. If you don't know how to praise me, I'm afraid someone will come over and praise you later.

"This is so troublesome. Can't our application be approved directly?" Hu Jiaran said speechlessly.

Li Youliang smiled. I'm afraid it's not appropriate to give a reply at this time. Oh, you refused before, but now you approve the Danish royal family’s request?

what does it mean? Are the foreign devils who co-authored the book superior?

"Let Dr. Lu and Zhao Kang lead a team to Denmark." Gao Feng considered, "Contact Xinhua Pharmaceutical and ask them to send a few people as well."

After all, Xinhua Pharmaceutical is a large pharmaceutical company and has a lot of dealings with foreigners. They feel more at ease when they send a few professional people to Gaofeng.

(End of this chapter)