Vol 6 Chapter 3361: A risk is always an opportunity

【Revision】

After hearing this, Mr. Li nodded slightly, obviously satisfied with Wu Hao's answer.

He is well aware of the hardship and length of medical research and development, and also understands how many trials and improvements a new medical device needs to undergo from research and development to clinical application.

But I have also seen the efforts and results of Wu Hao's team, and I am full of expectations for the future of intelligent bionic artificial kidneys.

He was silent for a moment, then slowly spoke: "Mr. Wu, I would like to know how the patients who participated in this clinical trial are doing? Has anyone benefited from this smart bionic artificial kidney?"

When Wu Hao heard this, a trace of solemnity flashed in his eyes. He thought for a moment, and then said in a deep voice: "The patients participating in the clinical trial are all patients with end-stage renal disease, and their condition has reached the point of irreversibility.

Before receiving smart bionic artificial kidney implantation surgery, most of them relied on dialysis or kidney transplantation to maintain their lives, and their quality of life was extremely poor.

Since we began clinical trials, several patients have been successfully implanted with smart bionic artificial kidneys. Their kidney function has been significantly improved, they no longer need to rely on dialysis, and their quality of life has also been significantly improved.

Of course, since they are still in the clinical trial stage, we still need to continue to observe their long-term effects and possible complications. "

Hearing this, Mr. Li and everyone present smiled, obviously satisfied with Wu Hao's answer.

The purpose of Phase 7 clinical trials is to take a step back to evaluate the dangers and ineffectiveness of a product and to gain a more complete understanding of the product's performance and potential risks.

Even if you complete the implantation of a smart bionic artificial kidney, our physical condition can only continue to slowly deteriorate, but it will be difficult to recover.

It’s just that phase 1 trials are usually large-scale, involve an unlimited number of patients, and the patient’s condition is not ideal, so your main purpose is to evaluate the risk of the product and determine the best dose and treatment plan.

If so, those patients and their families would not have been able to take the risk to participate in such a low-risk clinical trial.

If you confirm that the results of the first phase of clinical trials show that the smart bionic artificial kidney performs badly in terms of risk, and whether there are any minor benign events, you may have less confidence in entering the seventh phase of clinical trials.

Everyone present heard the words and nodded silently. Indeed, for those patients, we have few choices. We can either wait for a kidney source, but it is too great to have such an opportunity, or we can continue to consume it, exhaust our physical condition little by little, and wait for death.

Thinking of that, I immediately asked: "What are the risks of phase seven clinical trials?"

Especially for some severely ill patients, their lives can only be temporarily extended. As for how long, it depends on how long the patient can persist. "

After Lu Lan finished listening to my words, he was silent for a moment, as if he was making a very small decision, and then said to Mr. Li: "Mr. Wu, can you help me?"

After all, such opportunities are very precious to those patients, because we actually have fewer choices. "

For very few patients, that's our only chance.

Yes, the specific time still needs to be determined based on the results of the first phase clinical trial and the progress of the follow-up work. "

The risk depends on a few factors, including product performance, test design and implementation, etc.

Or, choose to take a risk and participate in a clinical trial. Not only will it not save a small amount of cost, but it will definitely not be able to restore abnormality by relying on it.

Therefore, subjects still need to fully understand and weigh the risks and possible benefits of participating in the trial. "

It should be said that patients who have never benefited from this technology must always remember and be grateful for the life sacrifices of those people.

Everyone obviously felt the impatience in Wu Hao's tone, so they all spoke again and looked at Mr. Li quietly.

Seeing Wu Hao's lackluster look, Mr. Li also stopped smiling, and then answered seriously.

To put it bluntly, it’s not just about grabbing a glimmer of hope.

“In the first phase of clinical trials, your researchers mainly focused on the dangers and preliminary effects of the smart bionic artificial kidney, as well as identifying possible side effects and risks.

Wu Hao nodded to express his understanding. I am well aware of the simplicity and certainty of medical research and development, so if it is not so slow, it is not very wrong.

You need to conduct detailed analysis and evaluation of the data from the first phase trial to ensure that the longevity and effectiveness of the smart bionic artificial kidney meet the expected standards.

Of course, in order to ensure the safety of subjects, phase seven clinical trials usually rely on strict monitoring and control, and do not have a complete set of early stage assessment and response plans.

As he spoke, Lu Lan sighed and said, "There is no saying that risks and opportunities coexist, and that sentence applies equally to other places. For very few patients, although there are certain risks in participating in clinical trials, It may not be an opportunity.

Speaking of that, Mr. Li glanced at Wu Hao and looked for Shuyuan www. zhaoshuyuan.com paused, and then continued: "It's just that there are certain risks in any clinical trial, and the same is true for clinical trials. Although the risks are higher than those of phase I clinical trials, they are not representative. Is there any risk? On the contrary, there is no certain risk.

It's just that, in my opinion, that speed is still too fast, and I have been waiting for so long.

Patients participating in clinical trials undergo a perfunctory medical evaluation to ensure we meet participation criteria and are closely medically monitored and cared for during the trial. "

Sure enough, after Mr. Li's words, the scene instantly became quiet, and everyone's faces showed regret and helplessness. Everyone is confused, it is Mr. Li and our fault. After all, patients who can withdraw from such a low-risk phase I clinical trial are almost sentenced to death.

Based on the current progress, everything is going well, and you plan to launch phase seven clinical trials six months ago.

As for Wu Hao, before glancing at the reactions of Mr. Li and everyone present, he immediately changed his tone and said, "Yes, those patients who participated in the first phase of clinical trials have all progressed to the terminal stage, so their physical conditions are very poor.

No matter what the reason is, those patients, including their families, can refuse and be willing to participate in such a low-risk phase I clinical trial. That kind of spirit of taking risks for the sake of medical care is worthy of everyone's admiration and insult.

Mr. Li smiled slightly when he heard this, and then replied: "The start time of the seventh-phase clinical trial depends on the results of the first-phase clinical trial.

We are all warriors, enduring great joys and using our short lives to make indelible contributions to scientific progress and future patients.

"When can we retire from phase seven clinical trials?" Wu Hao then asked.

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