Medical network May 3 - since "722 storm" drugs clinical data verification is still in shock and awe the pharmaceutical industry, and the CFDA also has maintained a high pressure situation, but the clinical trial data in the prohibition is false phenomenon. And controversial clinical data authenticity and normative definition of problem due to the interests of all parties involved, delayed indecisiveness, has seriously hindered the progress of clinical trial data for verification. 

 

Recently, the CFDA solicit public again on the drug clinical trial data verification issues related to disposal announcement (amended) opinion (hereinafter referred to as the "draft"), face to face with the problem, clear rules and punitive measures. The policy is further tightened, and it is vital that the CFDA is able to maintain sustained strength in this contest of interest and power. And there is no denying that the storm will continue. 

 

Special guest: tao chunlei, chairman of anhui wanbang medical science and technology co., LTD. "The medical observer" has been quoted by the special observer, the senior vice President of executive director of the resources group of the company. Zhao zhen, senior manager of mobei (Shanghai) biotechnology co., LTD. 

 

Medical observers: a series of inspections led to the withdrawal of many drug companies in the early days of the inspection of the storm. Today, the definition of clinical trial data is fairly clear and the penalties are escalating again. So will the industry repeat the "withdrawal trend"? 

 

Zhaozhen: previous self-examination led to a lot of "withdrawal", self-examination designed an elaborate game bureau, you can "withdraw", let bygones be bygones; If you do not withdraw, you will be punished severely. The country then conducted a series of inspections. In this replay game, companies have found that the government has moved on and the risk-preference players have become less and less, and the "withdrawal trend" has occurred. Now, although the punishment has been upgraded, it is also more humane. Plus the "water" that had been squeezed out before, I think it might not be as much as before. 

 

In the previous "withdrawal trend", some companies were still on the sidelines, although many companies withdrew. After all, we do have a practice in policy enforcement. I think, therefore, the industry is going on whether "withdraw agitation", countries are key to implementing and punishment strength can be greatly increased, and the central, local and industry can insist on doing it. 

 

Tao chunlei: I don't think there should be another big withdrawal trend. By contrast, most drug companies are more standardizing their own clinical trials after "722". Most of the withdrawal has been withdrawn, and the remaining ones that should be withdrawn are only a few. In addition, the bidders, CRO and clinical institutions have been changing the idea, may modify the data and the fraud motivation or thought of occasional, but its policy will not easily touch the red line. 

 

Medical observers: as the draft released again, it is thought that the formal policy will soon come, the pharmaceutical industry will set off a new round of clinical data verification "storm", and will be more fierce than any previous round. What do you think of that? Will the new storm come after the official release of the policy? 

 

The new round of clinical data checking "storm" will not be more fierce, it is difficult to determine. If formal documents are a hit, a more aggressive review of storms than any previous round will come soon. But once it's loosened, people will stay on the sidelines, and there's no such thing as a vicious storm, and there may even be a resurgence. In short, after the official documents have been made, the verdict is made. 

 

Tao chunlei: I don't think so. In fact, the post-722 check has been fierce enough and even a bit overdone. Now the industry is calling for more scientific, professional, and formal verification. That is, when the regulators are checking, they will stick to their principles and will not hold on to some minor flaws. I believe that future inspections will become more and more professional and will be accepted even if the inspections will be even fiercer. Because the ferocity is to make the product better. 

 

Zhao: I think that's a big probability. The medical industry has entered policy and control period in 2013, and the policy tightening is a very obvious trend, and the degree of professionalism is improving. The rain is not coming, it is coming, you must be prepared. 

 

Medical observer: how should the drug companies regulate themselves in clinical data? What do you suggest? 

 

The individual thinks, every one that has conscience of medicine to reach the medical person, should have normative consciousness, and can't say a suit, the action is another set. At the same time, drug companies should actively respond to the call of the state, pay more attention to research and development, and return to the rule of standardization of the entire pharmaceutical industry. I also suggest that more companies should consider doing a hundred years old rather than just making a lot of money. 

 

": IT's a professional advice such as better use of the IT technology to build their own clinical data center, with more professional clinical test units to cooperate, I didn't, because these is only for a few big players. But I suggest you keep doing the right thing. Now it's easier for people to do business. 

 

Tao chunlei: first of all, the pharmaceutical companies can no longer expect the country to relax policy. Although there has been a sudden tightening of the country's past regulations, the overall regulation has been spiralling. In addition, the clinical trial data is already on the trend, and drug companies should be required and regulated by strict standards. 

 

Second, drug firms should change in the past on the clinical trials, when manned style of cutting, and actively training and recruitment of clinical professionals, on the design, implementation, report the relevant scheme for the whole process of the control, to ensure that drug companies can according to the objective conditions of clinical trials and the relevant departments with clinical trials of objective conditions, make a judgment and response in time. Finally, when the clinical trial results is not ideal, drug firms must joint the parties involved, to analyze the reason, solve problems, and can no longer rely on modified or falsified data obtained.