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Chapter 145 The Pure Chinese Antineoplastic Drug Gastric Carcinogen No. 1 Comes Out

Hearing Shi Meisheng's words, everyone fell silent.

Indeed, everyone thought it was simple before, and they all considered the problem from the standpoint of the developer, without having to drive away the patient and their family members on the spot, and without having to face the patient's life and death.

"What I want to know is, how to solve this problem?"

Shi Meisheng put forward his own point of view.

Someone wanted to speak, but was stopped by Shi Meisheng.

"Let me add, you can just talk about the solution, don't talk about the difficulty. I'm looking for a method now. Even if this method costs some money, it's okay. It's a way of thinking."

Shi Meisheng added.

It could be seen that Shi Meisheng paid special attention to this issue.

Jiang Ming is also thinking about this issue. With so many patients, we can't just watch them despair.

After all, many patients, like Liu Fenglan, may only take a few weeks. It is unrealistic to ask them to wait until the clinical trials are completed.

"I would like to ask a question, is there any limit on the number of people in clinical trials by the Ministry of Health?"

After thinking for a while, seeing that no one spoke, Jiang Ming asked.

"There is no limit on the number of people, and there is no problem with how many people you want to use for clinical trials."

Sun Mengqing said so.

Hearing this, Jiang Ming was overjoyed. If this is the case, then it will be easy.

"Although there is no limit on the number of people, the Ministry of Health stipulates that all costs of clinical trials shall be borne by the trial companies. This cost includes a series of follow-up treatment costs due to side effects of drugs."

Sun Mengqing added.

Hearing Sun Mengqing's words, Jiang Ming understood what he meant.

In other words, you can do clinical trials at will, but if your drug is immature, all subsequent treatment costs or loss of life will be borne by the company.

This cost is not insignificant.

After all, no one can say for sure about the side effects of the medicine. If it does happen, it will be a batch problem, and the resulting treatment fee will be very high. I don't have the strength to afford it.

This has led to the clinical trials of pharmaceutical companies, which must be cautious.

And from point to surface, gradually exaggerate.

In this case, even if there are problems, they are small in number and can be dealt with at a small cost.

"I suggest that for the clinical trial of gastric cancer net No. 1, the scope should be expanded to ensure that the drug can complete the remaining two phases of clinical trials in the shortest possible time."

Jiang Ming thought over and over again, and finally suggested this way.

"Expand the scope? To what extent?"

Someone was puzzled and asked like this.

"Include all the patients who have come to Kyoto No. [-] Hospital."

Jiang Ming said so.

"This"

Hearing Jiang Ming's words, everyone was stunned.

Good guy, according to Jiang Ming's meaning, this is to achieve the purpose of being subject to full inspection in the capital.

What kind of clinical trial is this? It's simply putting a new drug on the market. Are you sure there won't be any problems?

Everyone is full of doubts.

Moreover, if there is a problem with Stomach Cancer Net No. 1, it will not end well.

After all, according to conservative estimates, in the case of conducting clinical trials in this way, it is conservatively estimated that there will be tens of thousands of patients.

The Xia Medical Group doesn't care about the cost of the medicine, but if there is a problem with the medicine, with the strength of the Xia Medical Group, it may not be able to bear it.

At that time, it is very likely that the Xia Medical Group will be dragged down.

Although the risk of doing so is great, the effect will also be very obvious.

Ordinary clinical trials take about 1-3 years, but according to Jiang Ming's approach, it is estimated that it can be completed in a few months.

After all, according to the sample size of tens of thousands, there is no need for detailed analysis, as long as the patient's physical data is recorded, and then the use effect is calculated.

What kind of treatment rate is clear once the screening is done.

Not to mention, the method of this clinical trial is quite tempting.

It is absolutely possible to complete the Phase III clinical trial as quickly as possible.

As for whether it can be listed, it depends on the experimental results.

"Mr. Jiang, will there be any problems with such a large sample size?"

Sun Mengqing asked.

It can be regarded as asking the aspirations of all the leaders on the scene.

"We can't look at Gastric Cancer Net No. 1 from a traditional perspective."

After thinking about it, Jiang Ming organized his words in this way.

"Traditional anti-tumor drugs are based on Western medicine. Clinical trials are done to verify the effect of the drug, and more importantly, to observe the side effects of the drug."

"Actually, our two goals have almost been achieved."

"Based on the existing sample size, the effect of the drug has basically been determined to be good. As for the side effects of the drug, to be honest, we have not analyzed the side effects in theory, and it is even more impossible in practice."

"After all, this is a pure herbal medicine with no side effects."

"So, I think it is reasonable to expand the sample data when it is determined that there will not be a large number of side effects."

Hearing Jiang Ming's words, the minister at the scene was thoughtful.

Thinking about it suddenly, it seems that it is really the same thing.

After all, this is a purely Chinese medicine. Even if the medicine is ineffective, it should not have side effects.

So, worst case scenario, the drug doesn't work well?

Thinking of this, Shi Meisheng became a little tempted.

During this period of time, the market was under too much pressure, and they were all asking about the launch date of Gastric Cancer Net No. 1.

Regardless of the pressure from Kyoto No. [-] Hospital, Shi Meisheng also wants to speed up the drug verification plan. In this case, why not do it in one step?
It's just that Shi Meisheng was hesitating about this decision, not daring to make it.

In the end, Shi Meisheng still did not make a decision on the shortening plan of the clinical trial.

Shi Meisheng felt that he still needed to communicate with his superiors about this matter and explain the stakes.

Of course, the higher authorities are very likely to call back this motion.

After all, as a department of the country, everything is done for stability.It is a great sin to do it knowingly that there are risks in it.

If there is no problem, everything is fine, but when an accident occurs, whoever made the decision will bear the responsibility, and there is nothing wrong with it.

Shi Meisheng's request went round and round to Long Zhiwei.Thinking of this, Long Zhiwei called Jiang Ming and asked about anti-tumor drugs.

Seeing Long Zhiwei's phone call, Jiang Ming was also a little strange. Long Zhiwei usually doesn't call himself. Could it be that there is something important?

"Hey, Jiang Ming, regarding pure Chinese patent anti-tumor drugs, have you encountered any problems now?"

Long Zhiwei asked straight to the point.

Hearing that Long Zhiwei was asking about Stomach Cancer Net No. 1, Jiang Ming had a clue in his mind. It seemed that someone had fed back the information to Long Zhiwei.

After organizing the language, Jiang Ming said:
"Long Lao is like this. A pure Chinese medicine anti-tumor drug for the treatment of gastric cancer has been successfully developed and is currently in the clinical trial stage. But because the treatment effect is very good, the news has spread, and now many people with advanced gastric cancer come from all over the country. of patients who want to participate in clinical trials."

"There are so many patients, the clinical trials cannot accommodate them. Moreover, the No. 1 gastric cancer net is the finished drug. According to the principle, the third phase of the clinical trial has not been completed, so it cannot be used on a large scale. But so many patients go to the No. [-] drug in Kyoto. It’s not easy to drive people outside after a hospital.”

Jiang Ming described the current difficulties to Long Zhiwei.

"What are you going to do?"

Long Zhiwei asked straight to the point.

"We want to expand the scope of clinical trials and include as many patients as possible in the trials. The number involved is relatively large. Will there be any problems?"

Jiang Ming questioned.

"How big is the specific scope?"

"According to our forecast, there are about 10 people."

Jiang Ming slightly expanded the range, and then said.

Long Zhiwei's heart skipped a beat when he heard Jiang Ming say that there were 10 people.

Good guy, 10 people, this number is too huge.

You should know that in general clinical trials, a few hundred people are almost enough, and those with low cost and low side effects may have nearly a thousand people.

But a project like Jiang Ming's, which reached 10 people, is quite frightening.

Moreover, Jiang Ming's project is an anti-tumor drug, and its complexity is second to none in drug research and development.

Using so many people for verification, if there is a problem, the impact will be too great.

"Are you sure?"

Long Zhiwei asked.

"Old Long, yes. According to the current clinical trials, the effect is very good. And there are basically no side effects."

Jiang Ming said simply and clearly.

"Oh, make sure there are no side effects?"

Long Zhiwei questioned.

"At least according to the current analysis and experimental observations, there is no such thing."

Jiang Ming said.

Hearing Jiang Ming's words, Long Zhiwei seemed to be thinking, and did not speak for a long time.

For Jiang Ming, Long Zhiwei still trusted him.

But this is the first verification of a pure Chinese patent anti-tumor drug, and it cannot be sloppy.

"Well, you do this."

After thinking for a long time, Long Zhiwei said.

"First of all, the number of [-] patients is indeed too much. It is impossible to do so many clinical verifications at one time."

Long Zhiwei said slowly.

"It is recommended that you follow the batches, and you can expand the scope appropriately, but you can't do everything you want."

"For example, it can be [-] for the first time, [-] for the second time, [-] for the third time, and [-] for the fourth time. As for how to determine the specific number, you should study it."

"But in any case, it is required to summarize the clinical data of the previous phase and ensure that there are no abnormal problems before starting the next phase of the trial."

Long Zhiwei said.

Hearing what Long Zhiwei said, Jiang Ming also felt that it made sense.

Indeed, we should not be blindly optimistic and put all our hopes on pure Chinese medicine preparations without side effects. We should conduct as detailed verification as possible based on the principle of sampling verification.

After all, this is a new drug, and it is anti-tumor, which is at stake in itself.

However, it is also good to be able to expand the scope, which can greatly shorten the time for clinical verification.

After getting the news from Long Zhiwei, Jiang Ming had a plan in mind. With Long Zhiwei's help, the follow-up must be much easier.

Xia Medical Group, Shi Meisheng saw the news of the Ministry of Health's approval, and was also a little puzzled, what should be done.

The approval document from the Ministry of Health requires Xia Medical Group to formulate operable verification measures in accordance with the principles of scientific experiments.

What are operability verification measures? Judging from the approval, it is not allowed to exaggerate the scope.

But how to change it depends on guesswork, Shi Meisheng feels tired.

Thinking of this, Shi Meisheng summoned Jiang Ming and Sun Mengqing to study countermeasures.

Seeing the approval document from the Ministry of Health, how could Jiang Ming not understand that this was a direct transfer of Long Zhiwei's approval document.

Sun Mengqing looked at the approval document, and then said:
"Mr. Shi, according to my understanding, the Ministry of Health wants us to re-evaluate the necessity. After all, the original experimental measures are scientific."

"Strictly speaking, our method of expanding the scope is unscientific. I suggest that we continue to use the previous measures. Although it is slower, it is safe."

Although Sun Mengqing also wanted to speed up the progress of the verification, the instructions from the Ministry of Health were unpredictable.In this case, it is better to follow the original plan.

Hearing Sun Mengqing's words, Shi Meisheng also agreed deeply. At this time, he still had to do it step by step.

After all, Xia Medical Group is a state-owned enterprise, and the right direction is the right direction for many things.

"Jiang Ming, what do you think?"

Seeing that Jiang Ming was silent, Shi Meisheng asked.

"Mr. Shi, I feel that we still need to speed up the progress of the verification. If it continues like this, things will really happen to maintain stability."

Jiang Ming suggested.

"Jiang Ming, it's not that I don't want to exaggerate the scope. You have also seen the approval from the Ministry of Health. Isn't it clear that we should not consider it!"

Shi Meisheng explained his reasons.

"Mr. Shi, my thoughts may be different from yours. If the Ministry of Health disagrees with the expansion of the scope, it will clearly express its disagreement. As for now, I feel that it should be a reminder."

Jiang Ming analyzed.

"remind?"

"Yes, I feel that our method may be unscientific and needs to be improved with scientific thinking. Instead of cutting this matter across the board."

Jiang Ming said with certainty.

"Oh, tell me in detail?"

After hearing Jiang Ming's analysis, Shi Meisheng felt that it made sense and asked.

After all, Jiang Ming is the recipient of a national science and technology award, and he was the one who met the minister. Presumably Jiang Ming has a better understanding of the minister.

"It's like this. I thought about it carefully. The original test method is indeed inappropriate, but the existing plan is a bit radical and lacks the basis for theoretical sampling. This is what the Ministry of Health said, lacking scientific basis."

"A one-size-fits-all approach, while simple, is extremely risky in the current circumstances."

Jiang Ming expressed his opinion.

"As for the specific approach, it is recommended to carry out the experiment according to the original plan on the basis of moderately exaggerating the sample."

"Oh?"

"For example, in the first phase of the clinical trial, there were 10 trial participants, we can expand it to 100 or 500, and conduct trials on these 500 at the same time."

"In the second phase, the quota can be increased from 100 to 1000 or 3000, and these people are also included."

Jiang Ming talked eloquently, expressing the basic ideas

(End of this chapter)