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Chapter 141 Clinical Validation
"When can clinical verification be started?"

Jiang Ming asked.

The previous verifications were all based on experiments such as laboratories and mice. If you want to put the drug on the market, it still needs to go through clinical verification.

This kind of clinical verification requires very strict requirements, and detailed comparative tests cannot be completed without a year.

Jiang Ming couldn't wait any longer. It has been more than half a year since the development of the Chasing Spirit project, and Liu Fenglan's stomach cancer can no longer bear it.

After all, it is an advanced stage of gastric cancer, and it has lasted for so long. If Jiang Ming hadn't asked the hospital to take medication regardless of the cost, Liu Fenglan's body would have been dragged down by the tumor cells long ago.

But even so, Liu Fenglan's body could no longer bear it.

Thinking of this, Jiang Ming came up with the idea of ​​a new drug and was going to let Liu Fenglan participate in the clinical trial.

"It will take some time. At present, the number of patients needed for clinical practice is currently insufficient."

Sun Mengqing said.

"Moreover, in order to carry out clinical trials on a large scale, it is necessary to have the finished drug, plus the preliminary trial report, for approval. It is estimated that it will take at least one month."

Sun Mengqing said.

Jiang Ming frowned a little, it would take too long.

Moreover, it was Xia Medical Group who had to go through the formalities. If it was an ordinary pharmaceutical company, it would take longer.

Of course, Jiang Ming understands the difficulty of the regulatory authorities.

It is very prudent to start the clinical verification of a new drug.

After all, it is a brand new drug and the potential risks are huge.

In history, it has happened many times that the drugs in clinical trials have not been fully verified in the early stage, resulting in a large number of drug side effects in patients.

Indirectly led to the death of many experimenters.

Although these experimenters were all seriously ill, desperate, and wanted to try new drugs, but this kind of death caused by lack of rigor was also something that the regulatory authorities did not want to see.

Therefore, the regulatory authorities need to invite authoritative experts to re-check the data of the drug to ensure that the pre-test work of the drug has been completed before the clinical trial.

"Can't wait, so, can we verify it on a patient first?"

Jiang Ming asked.

"A patient?"

"Yes, only one patient."

Jiang Ming said.

"If there is only one patient, as long as the patient agrees, there is no problem."

Sun Mengqing said.

"Okay, arrange to bring the medicine and equipment, and we will go to the First Hospital of Kyoto to test the medicine."

Jiang Ming said crisply.

"Ok."

Afterwards, Sun Mengqing organized R&D engineers, brought equipment and medicines, and drove to the First Hospital of Kyoto.

As an authoritative hospital, Kyoto No. [-] Hospital bears the heavy burden of scientific research for the entire Xia Kingdom's medical community.

At the same time, as one of the best hospitals, this hospital only transfers patients from lower levels, and there is no tradition of requiring patients to be transferred to other hospitals if they cannot be cured.

This confidence stems from the technical strength of the hospital and the superb skills of doctors.

Jiang Ming sent Liu Fenglan to Kyoto No. [-] Hospital, not because Jiang Ming was rich or insisted on the best, but because other hospitals no longer accepted Liu Fenglan.

Only Kyoto No. [-] Hospital has the strength to control Liu Fenglan's disease and delay the onset of the disease.

However, no matter how powerful Kyoto Daiichi Hospital is, it cannot cure an incurable disease like cancer. It is extremely difficult to control it to this extent now.

When Jiang Ming and others arrived at the hospital, the hospital's technical experts led by the director, Cheng Baoguo, had already been waiting for a long time.

It wasn't that the experts from the First Hospital were free and had time, but when they heard that Xia Medical Group had developed a new drug that might be extremely lethal to tumor cells, they gathered to watch.

As for the doctors in the First Hospital, their horizons are naturally very high.

But no matter how high the vision is, when they heard that there is a drug that can accurately kill tumor cells, and it is a pure traditional Chinese medicine with extremely low side effects on the human body, the experts first shook their heads.

After all, these words, precise, pure traditional Chinese medicine, and low side effects, are in opposition to the current status of existing anti-tumor drugs.

These experts would like to see if this description is exaggerated.

Moreover, in recent times, there have been very frequent reports about Xia Medical Group's new drugs.There's a lot of buzz on the Internet.

Some people even regard Xiayi Group as the leader of anti-tumor drugs, overwhelming foreign pharmaceutical giants.

As an insider, I naturally know that although the Xia Medical Group is strong, it is a bit exaggerated to say that it can beat foreign giants.

Now that they have the opportunity to watch Xia Medical Group's anti-tumor drug trials up close, how can everyone not be excited.

Of course, those who can come to watch are experts in the hospital, so there is nothing to say about the confidentiality of the new medicine.

But Rao is an expert figure, and dozens of them came.

This kind of strength is not comparable to that of ordinary hospitals.

This is also the foundation of Kyoto No. [-] Hospital.

Before the test, Liu Fenglan needs to do a comprehensive physical examination.

Therefore, even though Liu Fenglan was very weak, she still had to draw a lot of blood.

Seeing this, Jiang Ming felt a little heartbroken.But Jiang Ming also knows that all clinical trials of drugs must have this step, and it cannot be sloppy.

Since it was an urgent test, Liu Fenglan's test results came out soon.

There are a lot of densely packed examination results, which are much more comprehensive than the general physical examination items.

According to Jiang Ming's speculation, these inspections alone would cost several thousand.

This is still the inspection fee for one person. If clinical verification is carried out in large quantities, the cost will be shattering.

This is why developing new drugs costs money.

But doing so is also very necessary.Through this comprehensive inspection, the patient's physical condition can be clearly known, and can be compared with that after medication.

In this way, it is possible to visually detect whether the drug is useful to the body.If so, how effective is it.

These subtle data are the status that developers pay attention to.

It has to be said that Liu Fenglan's physical condition is already very poor, and most of the indicators have seriously deviated from the standard values.

This means that Liu Fenglan's various organs are being seriously damaged.

According to the doctor's guess, Liu Fenglan could not last long in this state.

If this clinical trial drug is ineffective, Liu Fenglan will not last for a week.

Liu Fenglan's physical condition has been recorded, and the next step is to take the experimental drug.

Before taking the new drug, doctors had stopped other anti-tumor measures.The purpose of this is to reduce the effect of other drugs on the new drug.

New drugs are taken by swallowing in order to reduce the damage to the body caused by drug use.

After all, infusion is more efficient than swallowing.

However, swallowing will cause the problem of weakening the efficacy of the medicine. Therefore, in order to ensure the efficacy of the medicine, a special capsule coat must be used to wrap the medicine to prevent the medicine from being decomposed in advance in the body.

Of course, these have no effect on the new drug developed by Xia Ke Institute.

As Liu Fenglan swallowed the medicine, the developers at the scene became nervous.

They must always pay attention to the symptoms of patients, and then find out the effects of drugs on the body from various signs.

Even the failed cases have extremely high reference value.

The clinical trial staff were in the room, and other visiting experts were waiting quietly outside the glass window.

The effect of the drug generally has a delay of 1-2 hours, so there is no rush.

However, although the results have not come out, according to the opinions of these experts, even if the test is successful, Liu Fenglan probably cannot be saved.

After all, Liu Fenglan was too seriously affected by tumor cells,

Tumor cells have spread throughout the body, and it is almost impossible to completely remove them.

Even if the number of cells is reduced, the number that can be reduced is not much.

Xia Medical Group also made a fool of themselves, choosing Liu Fenglan as the subject of the clinical trial.

For very serious cases like Liu Fenglan, it is difficult for you to figure out whether the medicine is ineffective, or the medicine is ineffective because the patient is too sick.

Of course, these experts didn't know that it was because of Jiang Ming's arrangement.

Otherwise, even if Liu Fenglan signs up, there will be no place for her in the end.

At this time, Liu Fenglan, as the first patient to use this anti-tumor drug clinically, received special attention.

Time passed quickly, and medical staff were drawing Liu Fenglan's blood to test key indicators.

"what!"

The result came out, and Jiang Ming was a little surprised when he saw the result in his hand.

I saw that the key biochemical index, the number of alpha-fetoprotein, has dropped significantly.

You should know that alpha-fetoprotein is used as a tumor marker. For patients with advanced cancer like Liu Fenglan, the value will be very high and cannot be reduced.

Now it has dropped for the first time, which is a bit surprising.

Could it be that the antineoplastic drugs are effective?

Jiang Ming couldn't help but think this way.

It's not just Jiang Ming who thinks this way, the research and development engineer who is doing the clinical trial is also very happy when he sees this result.

Judging from the current test sheets, some of the patient's values ​​are no longer declining, but are showing an upward trend, which is good news.

Of course, the time is still short, and we still have to wait for a while to be completely sure.

"yeah!"

After a while, looking at the inspection data in his hand, a research and development engineer shouted unconsciously.

So far, the patient's physical indicators have been significantly improved.

The number of tumor cells has been greatly reduced.

The experts observing outside, seeing the excited expression of the clinician, were also guessing whether this anti-tumor drug was effective.

Of course, experts also believe that the anti-tumor drugs carefully developed by Xia Medical Group are definitely effective, but to what extent they are not sure.

In a blink of an eye, four hours later, the clinician sent exciting news.

After testing, the tumor cells in the patient's body have been reduced by about 40%.

Hearing this number, the experts from the First Hospital had an expression of disbelief on their faces.

40% of the tumor cells are reduced, what kind of effect is this, all experts know.

This is the result of one week of general anticancer drug treatment, plus two weeks of chemotherapy.

Moreover, this achievement is accompanied by a large number of side effects.

I didn't expect Xia Medical Group's drugs to be so powerful, and to achieve such results in such a short period of time is a bit scary.

They subconsciously thought that there was something wrong with the test results.

But when they thought that many key tests were carried out in the First Hospital and were done by their colleagues, all the experts fell silent.

This means that the pure Chinese anti-tumor drug of Xia Medical Group is indeed effective.

And this effect is being continuously released.

After all, the validity period of general drugs is about 2 days.

In the later period, although the effect of the medicine is less, but the duration is there, it still has a great effect.

Due to the subsequent verification, it took too long, so all the experts left one after another.

Although he left, experts still visit the site from time to time, and at the same time inquire about the effect of drug verification.

Jiang Ming hasn't done anything for the past few days, but has been paying attention to Liu Fenglan's condition.

Seeing that the tumor cells in Liu Fenglan's body had been reduced by more than 70% after one dose of medication, Jiang Ming also breathed a sigh of relief.

This effect, in everyone's expectation, was similar to Xia Medical Group's previous estimate.

Of course, this is also related to the physical condition of the patient.

The earlier the treatment, the better the physical condition, and the more tumor cells can be eliminated at one time.At most, it will exceed 80%.

Liu Fenglan's physical condition is already very poor, and Jiang Ming is already satisfied with achieving 70% of the effect.

Two days after the first medication, Liu Fenglan's mental state has improved.

Liu Fenglan's condition was very poor before, and her face was very pale.I was so weak that it was very difficult to move.

But after one dose of medication, Liu Fenglan's face became much ruddy and she was able to go to the field normally.

And more importantly, Liu Fenglan was able to eat by herself.

Although there is not much to eat, it is good to be able to eat a little.

Compared with before, relying on nutrient solution for maintenance, it is a world of difference.

Seeing this obvious contrast, the members of the Xia Medical Group project team also showed satisfied smiles.

As for Liu Ming, the clinical doctor in the First Hospital, he was deeply incredulous.

As Liu Fenglan's attending doctor, he is very aware of Liu Fenglan's physical condition.

To be able to heal to such an extent is simply miraculous.

Now, the drug is only used once, and 70% of the tumor cells have been eliminated, and it will be used twice for a total of one course of treatment. Liu Ming will wait and see if more can be eliminated.

Liu Ming had a vague feeling that he had witnessed history, witnessed the birth of a miraculous Chinese medicine, and it was used to treat the symptom of malignant tumor cells.

After all, according to Liu Fenglan's current concentration of tumor cells, generally speaking, the doctor would suggest to leave the hospital, go home to recuperate, and review at any time.

Liu Fenglan is not fully recovered now, because she was too seriously ill before.

(End of this chapter)