Chapter 50 The clinical phase III effect of explosion! (Please support me by reading monthly!)
Clinical trials use double-blind testing. Not only do patients not know whether they have entered the "experimental group" or the "control group" (placebo), but also the implementers Neither the statistician nor the statistician knows who is in the experimental group and who is in the control group until the end of the experiment.
The purpose of this is to reduce the impact of subjective bias and expectations on the results.
Listening to everyone's discussion, Xia Qiang felt slightly relieved.
He was the same as the person who spoke at the beginning. Starting from the second month of treatment, he clearly felt the changes in himself.
Not only did the symptoms of dizziness and fatigue completely disappear, but even if I was so busy delivering food that I didn’t even bother to take a sip of water, I never felt as dizzy as before.
He asked that eating "Qingshan Ava" can indeed relieve these symptoms, but it can still easily cause adverse reactions once high-intensity work is done.
In other words, he is very likely to have entered the experimental group, and it is very likely that he will actually be cured of his aplastic anemia!
However, as everyone has discussed, under double-blind testing, only the bone puncture results are the only gold standard.
Thinking of this, he couldn't help but lightly clenched his fists!
"God, bless me."
The first batch of "ITG Human Myelopoietin" was for 75 people. Although there were a lot of people, when the clinical trial center was operating at full capacity, at 11 o'clock in the morning ,
The last examination of seventy-five people was completed, and everyone was lying on the hospital bed, quietly waiting for the 24-hour results.
At noon the next day, all patients with bone perforation were able to get out of bed. At one o'clock in the afternoon, Feng Gang and Zhang Yang, deputy directors of the clinical center, came to the lounge with 75 bone perforation reports.
“Everyone has been waiting for a long time. In order to avoid multiple bone penetrations, the center will make an exception this time and inform you of the results in advance.”
"No. 1, Yan Xiaoduo."
Yan Xiaoduo is the leader of the patient group. Not only was she among the first to participate in the clinical trial of avatrombopag, she also called on everyone in the group to actively participate. Clinical trials of “ITG”.
Everyone’s eyes fell on Yan Xiaoduo. At this moment, everyone couldn’t help but hold their breath.
Yan Xiaoduo was even more nervous and trembling. Even though she felt good about herself, she was still uncontrollably afraid and worried at this moment!
“Congratulations, the results of the bone biopsy are very good. Judging from the biopsy, you have been completely cured of ‘aplastic anemia’!”
"Really?!"
If it hadn't been for the bone puncture just now, Yan Xiaoduo would have almost jumped with excitement.
But the next second, she suddenly burst into tears and cried softly.
The family members on the side also cried with joy, comforting Yan Xiaoduo while receiving the report.
Zhang Yang also breathed out gently. This may be the meaning of the existence of Qingshan Pharmaceutical.
"Li Bing."
"Here!"
"...Your blood picture is not bad, but the bone biopsy result is still 'severe aplastic anemia'."
Li Bing , was a patient who came to Chengdu from Mian City after being introduced by Yan Xiaoduo, and offered to participate in the third phase of the "Qingshan Ava" clinical trial without any subsidy.
This time, he also joined the first batch of clinical trials of "ITG".
The lounge suddenly became a little depressed. Even Yan Xiaoduo, who was crying with joy, stopped crying and comforted in a low voice:
"Li Bing..."
It would be a lie to say that I am not disappointed, Li Bing. After receiving the report, he lowered his head heavily, and everyone could see that the light in his eyes had completely dimmed.
But as soon as he took a step, he suddenly turned around and looked at Zhang Yang:
"Mr. Zhang, can you tell me? Is it because I don't respond well to 'ITG Generator', or... …”
Before he finished speaking, Zhang Yang gently patted Li Bing on the shoulder.
"Don't worry, it's not the problem with the medicine, it's that you entered the 'control group' this time."
"Really?!"
Li Bing's eyes lit up instantly !
It’s not that I didn’t respond well to the medicine, it’s that I didn’t take the medicine!
In other words, once you take the medicine, you still have a chance to heal!
"No. 21, Xia Qiang!"
Xia Qiang was stunned, and his heart suddenly rose to his throat.
"Congratulations, the results of bone puncture are also very good. From clinical judgment, you have been completely cured of 'aplastic anemia'!" Xia Qiang was stunned, took a deep breath, and then said Zhang Yang bowed heavily.
"Mr. Zhang, thank you."
"On the 23rd, Miss Zhou..."
The bone puncture reports of 75 people were sent to everyone one by one. At the beginning, Those patients who learned that they had not been cured were still very disappointed.
But gradually, everyone was surprised to find that it was not that the medicine was ineffective, but that all the patients who had not been cured were actually the "control group"!
Hiss!
In other words, those patients who entered the "experimental group", regardless of ordinary aplastic anemia or super severe aplastic anemia, were all completely cured!
The cure rate is as high as 100%!
The frustrated patients suddenly became excited. The fact that they were not cured was not because they were incompetent, but because they were a bit unlucky. They still had a chance to be completely cured!
As long as,
as long as "ITG Human Myelopoietin" is launched on the market, they will be able to achieve a complete cure!
"Mr. Zhang, this is not fair. You must rush to market! I really want to take a shot of generogen!"
"Mr. Zhang... If it doesn't work, you can try the third phase of clinical trials again and let me enter." Can you do the test team? "
"Mr. Zhang, just sell it to me privately now. Just tell me how much it will cost, and I will never bargain!"
Listen to these tigers and wolves! With these words, Zhang Yang and Feng Gang quickly ran away.
Five minutes later, the message "slipped" out quietly.
Naturally, the first to get the news were the major patient groups!
Of the 75 reports, 40 were completely cured bone penetration reports. What’s even more terrifying is that the remaining 35 uncured reports were all from the control group? !
"His! Group leader, are you telling the truth?! 75 copies, 40 test groups, 40 all cured?! 100% cure rate?!"
"My Oh my god! Three months, three months to achieve complete cure of aplastic anemia! And no matter the type!"
"Hurry, tell me, are there any clinical trial places? Participate! ”
"What are you thinking? You weren't active before? Now you want to participate again! It's long gone!"
The news spread quickly, and Sister Sun, who was in the same hospital bed with Xia Qiang before, also saw it on the phone screen News in the group.
At this moment, she suddenly looked at her son who was lying on the hospital bed preparing for a bone marrow transplant, and she felt a trace of regret in her heart.
"If I had made the same choice as Xiaoxia, maybe my son would have been cured."
"Maybe, I was really wrong..."
…
The news spread far beyond everyone’s imagination. After the 100% cure rate of “ITG Human Bone Marrow” broke out in the group, the group of aplastic patients across the country went completely crazy.
Xihua Hospital.
“Honey, good news, the group says that Qingshan Pharmaceutical has developed a 100% cure for aplastic anemia, and we don’t need bone marrow transplantation anymore!”
“Is it true? ?”
"Really, they even sent out the puncture reports before and after. It can't be fake! Can you take the medicine for a few more months?"
"Yes! Husband, let's just transfer to the hospital. We're here Wait over there!”
“Okay!”
Ruijin Hospital in the city.
"Daughter, we are not going to the warehouse anymore, we are not going to transplant anymore, we are discharged from the hospital, we are going to Chengdu!"
"Dad? What's wrong?!"
"You didn't read the news, did you? The Third People's Hospital of Chengdu is said to have developed a drug that can completely cure 'aplastic anemia'!
It can be eaten We don’t want to transplant medicine. Not only is the risk of transplant infection high, you will have to take antibiotics for many years. Rejection medicine is harmful to the body!”
“Is it really possible to take medicine to cure it? Dad, please find out, we will go there right away!”
In a moment, the news spread across the country! , not only patients from around Chengdu came in droves, but patients with aplastic anemia from all over the country could no longer sit still!
Especially those patients whose drug treatment was not effective or who were preparing for bone marrow transplantation all rushed to Chengdu Third People's Hospital because of this news!
In just one day, the number of registrations in the Hematology Department of the Third People's Hospital surged!
Of course, some people are taking action and some are still waiting and watching.
However, when the complete phase III clinical data from Tsingshan Pharmaceutical’s official statistics were updated on the State Food and Drug Administration website two days later, all doubts disappeared!
As soon as the news came out, the industry was shocked!
(End of this chapter)