According to the official website of the State Food and Drug Administration，As of January 21, 2016，Due to clinical trial data unreal、Improper and other questions，The State Food and Drug Administration will not be approved、stake online sports bettingMy stake betting apppharmaceutical companies' self -checking applications for withdrawal of drug registration are as high as 1184，Occasionally require 73%of the total number of self -check inspections。If you deduct 165 free clinical，This proportion reaches 81%。

 

  Staff of the Food and Drug Department said，During the verification, I found that many drugs of drugs were incomplete，Analysis data without level difference，Some data cannot trace the source。Another company deliberately concealed the report、Leaming Report Bad React Record，Modify the test data that can not be met。

 

  early September，A & ldquo; 80 % of the clinical data of 80 % of the new drugs behind the regulatory links behind the regulatory links & rdquo;，The direct consequence of clinical data fraud is the poor efficacy，From a certain degree of perspective，Clinical data fraud affects everyone。

 

  Sources: The State Food and Drug Administration launched a self -examination of clinical trial data for drugs for one year，It is found that the clinical data of over 80 % of new drugs is involved in fake，The regulatory link behind the regulatory link is losing layer，Pharmaceuticals、Intermediary、Doctors and other related subjects illegal issues are prominent。

 

  Drug clinical trial data is of great significance in drug research and development innovation，Standardized and reliable clinical trials are the key links My stake betting appstake sports betting appto ensure the quality of drugs。As the last ring developed as a new drug，Speaking of drugs developed by tens of millions or even hundreds of millions of dollars，Is there any efficacy、Safe and unsafe，Mainly rely on test data to measure。Drug clinical trial data fake，Not only will it bring huge safety hazards to the patient's medication，and will affect the innovation and upgrade of my country's pharmaceutical industry。

 

  Status

 

  False in the clinical trial stage is not news

 

  Clinical trial results，Not only the only standard for testing drug safety and effectiveness，It is also the key basis for the registration of medicines。Yu Pei, director of the Department of Pharmacy at the School of Pharmacy of Jinan University, said，Strict specification、Data reliable clinical trials，It is a key safety barrier before the pharmaceutical listing，It is also the core basis for the drug supervision department to support the listing of drugs。But the survey found，The clinical trial stage of our drugs in the clinical trial stage before listing is no longer a news。

 

  Data counterfeiting starts with preclinical research。& ldquo; Before the market is listed，Must be a human clinical trial。But from the moment the selection of the subject enters the group，False will happen all the time。& rdquo; Introduce a person in charge of a pharmaceutical company who do not want to disclose the name，Clinical trials often adopt & ldquo; competitive group & rdquo; method，How many subjects of the enrolled group will directly determine how much the doctor's future signature signed and scientific research fund，If a project needs to meet the test requirements of the test requirements, 100 people，But the number of people did not get enough before the planned date，Only 80 people，or even 60 people may start。Facing the lack of，Data can only be fabricated from scratch。

 

  Not only that，The actual operating record is not true, it is also used to fake means。"China Journal of Clinical Pharmacology" in 2013 on a survey of domestic experimental agencies，The proportion of irregularities of test records is as high as 85.7%，It is the most problematic link in clinical trials，Only 1/7 nationwide institutions have not found problems。

 

  False may appear in any link of clinical trials

 

  Imitation drugs in dosage form、Specification、In terms of quality and efficacy and indications，All should be equivalent to the original research medicine，This is the consensus of the medical community。Some stake online sports bettingMy stake betting apppharmaceutical companies are in order to maximize the dismissal，However, clinical trials are often & ldquo; ignore & rdquo;。The boss of a large biopharmaceutical company disclosed，90%of domestic generic drugs cannot meet the original research drug standards。In order to pass the review，concealing data、The phenomenon of selective data is very common，Pharmaceutical companies will even join the doctor to modify the data。

 

   & ldquo; The clinical data of the drug is not real、Irregular，The reason may not be caused by the enterprise。& rdquo; General Manager of Zhejiang Pharmaceutical Co., Ltd. said，The cause and power are multi -faceted，May appear in any link of the entire chain of clinical trials。One aspect，my country's current laws and regulations on the supervision of clinical trials of drugs are not complete; on the other hand,，The number of drug clinical trial institutions is too small，The number of items that need to be carried out every year is seriously not matched，Lead the clinical trial institutions to be overwhelmed，Quality affecting clinical trials、Specification。

 

  Question

 

  Data counterfeit supervision is still & ldquo; hand soft & rdquo;

 

  The extremely important data in the clinical trial of new drugs is often ignored today。abroad，Data statistics cost hundreds of thousands or even millions of RMB，Data statistics from Chinese hospitals only need to spend tens of thousands of yuan。

 

  China implements a qualification certification system for clinical trial institutions，Only clinical institutions approved by the drug supervision department，can participate in clinical trials。The actual situation is often，New drug test enters the phase I clinical trial is very difficult，Once you enter, you can go all the way。

 

  According to the practice，stake online sports bettingMy stake betting apppharmaceutical companies often send supervisors (CRA) to supervise clinical trial institutions。After the clinical trial is over，CRA will collect approval data and hand over to the data processing agency for analysis and compilation，Data and reports that are finally formed to be submitted to the Drug Review Center for the Drug Administration。But because of the lack of third -party supervision and checks and balances，Hospital as a clinical trial institution problem frequently。Some pharmaceutical companies In order to achieve the purpose of approval，It will also modify the data with the statistical unit。Although the General Administration clearly stipulates，If clinical research materials stake betting appare falsified，stake betting appThe applicant's newly proposed drug registration application will not be accepted within 3 years，Direct responsible persons participating in research or organizational research will not be accepted within ten years。But for a series of data fake problems existing，Supervisor is still showing & ldquo; Hand soft & rdquo;。

 

  Dr. Liao Guojuan, CEO of Suzhou Jinwei Zhizhi Biotechnology Co., Ltd.，In the United States，Once the data is fake，stake online sports bettingMy stake betting apppharmaceutical companies and R & D personnel will be included in the blacklist，You must not enter related fields for life。

 

  countermeasures

 

  New drug research and development must take the main road

 

  Since April 2015，Almost every month has a number of drug review and reform of the new policy。November 11 last year，The State Administration of Food and Drug Administration also released the "Announcement of the State Food and Drug Administration on several policies for drug registration review approval policies" on its official website，Proposal to improve the approval standard for generic drugs、Ten new regulations for review and approval of clinical trial applications。For clinical value、Real new drug creation，This or a gospel。But after a year，A message of 80%of the clinical data of new drugs is still revealed，This has to make people contemplate: which link is a leak?

 

  For the status quo of the development of new drugs，The general manager of a pharmaceutical company in Nanjing feel helpless: regular enterprise takes the road，However, it is found that companies who have fallen fake and approach are faster than their own approval。

 

  President of Shenzhen Biotechnology Co., Ltd. also said，Many innovative enterprises focusing on drug research and development have done an innovative medicine for ten years，Each data is done seriously，Instead, he loses losses when competing with data fraud。& ldquo; Strict review clinical research data should not only be executed early，and should also insist on promotion。Although the progress of regular products in the short term may be affected，But after checking the normalization，On the whole，It is conducive to the healthy development of innovative enterprises。& rdquo;

 

  Encourage real innovation with the strictest system

 

  Some people in the medical industry think，At present, there are two negative theories that need to be vigilant: First, the promulgation policy must be in line with Chinese national conditions，At this stage, the requirements for innovation must not be too advanced; the second is that the policy cannot be cut，Some clinical data is just irregular，Not fake，Allow existence。

 

  stake online sports bettingFor stake online sports bettingthis，Expert Suggestion，To ensure the authenticity of the clinical data of the drug，can refer to the advanced maturity of Europe and the United States，Zero tolerance for clinical data fraud，Effectively ensure the safety of patients' medication; at the same time, more doctors should be allowed to engage in clinical trials of drugs，Control the quality of clinical trials; establish a third -party supervision system，Increase supervision。Another，You can also use electronic information technology，Establishing a drug clinical trial database，Requires the clinical institution to report to the clinical trial data in real time，Publicly open to the society，Realize national supervision。

 

  Industry authoritative person said，Currently is the key period of governing the field of governing drugs & ldquo; bad coins expel good currency & rdquo;，Must be used to encourage real innovation。So，Call for laws and regulations such as the "Specifications for the Management of the Quality Management of Drug Clinical Test" as soon as possible，Further improve the system supervision;，Really form a core competitiveness through innovation。