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"It's hard to find a clinical inspector (CRA) now. It's not surprising that you pay three times as much. Now it's a robbery." Shi yonghua, who is engaged in CRA personnel management at yingfan da medical consulting (Shanghai) co., LTD., recently lamented to the first financial reporter.
CRA is a pharmaceutical enterprise or pharmaceutical research and development outsourcing institution (CRO), which connects the important link of the clinical trial center and is responsible for the clinical supervision of related projects.
The medical r&d outsourcing industry has been caught in the CRA's talent shortage overnight, thanks to the "July 22" medical clinical trial that shocked the industry two years ago. At first, the industry was so shocked that it was described as "tragedy". This verification has been ongoing for two years.
On 21 July this year, total bureau of national food and drug supervision and administration of the food and drug review inspection center (hereinafter referred to as "CFDI") announced the drug clinical trial data check periodically report (July 2015 - June 2017), and drug clinical trial data for two years the inspections conducted a periodic summary. The public figures are striking. The report showed that the number of registered applications for withdrawal of applicants reached 1,316, accounting for 64.71 percent. The big difference is that there are only 258 registered applications that do not need to be verified, such as clinical trials, and only 12.7% of the total.
The supervision of the clinical trial data of the whole body has been checked, and the situation of the clinical trial fraud has been clearly curbed, which has purified the drug research and development ecological environment. But "post-disaster" also faces how to rebuild the problem, which is undoubtedly a systematic project, which tests the wisdom of policymakers, and also needs to coordinate with regulators, medical clinical trials and other parties.
Thunder sweep
On July 22, 2015, the state administration of food and drug administration (CFDA) issued a report on the authenticity of the clinical trial data.
A vigorous inspection of the storm has begun.
In recent days, some people in the pharmaceutical industry told the first financial journalist that the industry was at first dangerous.
News of the drug companies' initiative to withdraw the new drug is pouring in. At that moment, there was no known or unknown division between the drug companies that withdrew.
Seen as the CFDA's "most severe verification storm", the boots landed on the back of a variety of complex factors. If the drug that has accumulated over the years is declared "quake lake", there is a need for "flood discharge"; In the case of clinical trial data, there is an unstandardized declaration program, which needs to be cleared.
To the pain of drug companies, the withdrawal of drug declaration or the possibility that the initial r&d investment will be wasted.
With the collective withdrawal of drug companies, the fear of the outside world is like a shadow of the shadow. Is the trust of drug clinical research in China so inconceivable?
"Staff employed by foreign drug companies were the heart is very tangled, what should be how to foreign headquarters interprets the CFDA action at this time. Public opinion is rendered, foreign some drug companies and even give up investing in China directly to carry out clinical trials research." Zhang bin, head of China research and development strategy and operation management of Merck snow leno (Beijing) pharmaceutical research and development co., LTD., told the first financial reporter.
Sun yat-sen university cancer prevention and control center of the relevant person in charge of drug clinical trial institution said in an interview with the financial journalist, CFDA in the July 22 "second anniversary to the pharmaceutical industry to hand over his report card, the bottom spirit is commendable, full of sincerity and confidence. Everyone has noticed that the applicant has withdrawn 64.7 percent of the registered variety, which is a bit of a breath of fresh air, and if you don't analyze it carefully, there is a lot of suspicion in the outside world.
"' withdraw 'show? It is for the standardization of the test process, data integrity, lack of confidence; 2 it is to wait and see; 3 it is the test data authenticity problems; 4 it is registered varieties aging, choose to give up." Behind the head also said that actively withdrawn are under regulatory pressure caused by, it highlights the regulatory decision, at the same time embodies the industry conscience, aims to reshape the industry confidence, to reassure the people.
A number of industry insiders said, the whole Chinese medicine clinical research has not yet fully connected with the international aspects, therefore, the CFDA current governance power is also not "overdo", on the contrary, it is prompted industry standardization must go through before the pain.
The CRA talent shortage has suddenly appeared
In the past two years, the industry has been in a very complicated mood.
When the CFDA drug clinical trial audit verification policy was introduced, CRO was busy coordinating the supervision of the research project, which resulted in the failure of the research project progress, and faced with the revenue crisis.
Boji pharma, which was listed on the gem in April 2015, was soon caught up in the storm. After falling more than 30 percent in 2015, the bottom line was the 2016 performance, with net profit plunging by more than 90 percent. Companies are skating on thin ice.
In recent economic medicine chairman secretary office staff told the first financial reporter: "the CFDA based on improve the quality of clinical research for the purpose of comprehensive verification activities, bo as large domestic CRO companies, the audit caused certain effect, but this has prompted bo economy must be in clinical trial quality, and schedule to invest more than ever before and more guarantee. In the second half of 2016 began to bo medicine clinical basic has returned to business, it can be seen in the CRO industry recovered."
Shi also told the first financial reporter that there is no shortage of business in the CRO industry, but CRA talent is missing. "From our company's database, there are 58,000 CRA in the United States; there are only about 8,000 CRA in China."
When it comes to the sudden outbreak of the CRA talent shortage, shi believes that there are several reasons for the superposition. The first is that there is no need for CRA because of the low level of repeated research in domestic pharmaceutical factories, or the lack of talents in scientific research or in clinical trials. Now that CFDA has checked, some drug declarations need to be redone in clinical trials; Secondly, CRA is required to conduct self-examination according to the verification requirements; Third, the approval time for new drug registration is greatly reduced, which encourages other new drug development, which also requires CRA staff.
The shortage of CRA personnel directly leads to the problem of human cost climbing. "As long as a CRA for a year, wages become three times are not uncommon. In cities such as Shanghai, offer only need thousands of yuan a month before, now want to climb to ten thousand yuan of above. The current domestic few colleges and universities have special training CRA, most of the CRA personnel by 'master train an apprentice grew from this model. Can be said to be did to people in the industry now mad." "He grinned helplessly.
Clinical resource shortage
It is a systematic project to verify the post-storm reconstruction of medical clinical trials.
In addition to the CRA talent training, a practical problem in the pharmaceutical industry is how to solve the resource shortage of clinical trial institutions.
Third-party medical service platform Shi Lichen MaiSiKang lai's founder said: "now have an aptitude for clinical research and development department is still few and far between. Even fewer good clinical trial institution. Why there are so many enterprises are not cooperate to do a good job before clinical trials, is because there are too many projects waiting to clinical trials. In clinical resources under the stress of the situation as well as the time is short, some drug companies settle for second best, choose some departments to carry out comparative lack."
Zhang also said that the current clinical trial center is also following up the verification and has invested a lot of manpower and resources, which has further led to the new clinical trial project. Clinical research resources are thus stretched.
The sun yat-sen university cancer prevention and control center of the relevant person in charge of drug clinical trial institution also said that in view of the limited clinical resources, the agency has gradually clear the hospital's research focus, structure optimization and research project, support domestic branded and is benefit for patients with advantages of the project.
The above said, as the testing agencies and researchers, many of the exposed in the verification of the quality problem, even the authenticity that nots allow to ignore, especially the test units "qualification" may be transformed into "records", means more opportunities and challenges coexist.
"' after July 22 ', we also like the industry peers in rethinking their gain and loss and the success or failure. First of all, we insist on the specification, the rigorous management idea, insisted that the applicant and the responsibility consciousness, don't act as a" nanny "attitude is correct; second, to strengthen the team of all types and at all levels personnel training, strengthening, update knowledge, clinical trials in clinical practice, through standard make clinical trials and clinical practice is feasible; in addition, adhere to the training and use your own research nurse/CRC, moderate open the third party to assist the test implementation is the key to through the strict verification." "The director added. |
