80% clinical data involving fake regulatory link layers fall behind solid converter

80% clinical data involving fake behind the regulatory aspects of the fall of 80% layers of data involving fake medicine drug exposure bad ecological beware of verification "too far" and other negative arguments weaken the supervision of the State Food and Drug Supervision Bureau started drug clinical trial data checking and verification work over the past year, found that over 80% clinical data involving fake, regulatory link layers fall behind, pharmaceutical companies, intermediaries, doctors and other related subject violations prominent. Some medical professionals believe that with the verification of the storm forward, "too far" "negative tone rise, our country should adhere to the clinical fake zero tolerance, with more strict supervision to reverse the bad money drives out good money pharmaceutical ecology. The enterprise deliberately concealed omissions records of adverse reactions to food and drug administration to treat the batch production of the 1622 drug clinical trial project data authenticity, normative verification results caused by vibration in the whole industry. Some industry sources, with the deepening of self-examination and verification work, more of the drug clinical trial data is not true and the specification of the problem was exposed, currently over 80% of the new drug application is withdrawn or pharmaceutical companies to the State Food and Drug Administration through. The food and Drug Department, a staff member said that the inspection found a lot of drugs clinical trial data analysis of the data is not complete, no differential path, some data can not trace. Some companies deliberately concealed, false records of adverse reactions, to modify the test data is not up to expectations. In this round of self-examination and verification of the storm, the clinical data fraud is an open secret in the industry." West Hospital Dean said, pharmaceutical companies with any combination of drugs, some hospitals do clinical trials, of course, are reported in accordance with the expected results, the State Food and Drug Administration in accordance with the approval of new drugs. "This drug development mode with large dishes, how to ensure drug quality and safety." The direct consequence of clinical data fraud is poor efficacy." Nanjing is a development of the pharmaceutical companies responsible person said, a clinical trial, the company will be the subjects taking metformin domestic anti diabetic drugs replaced the original drug glucophage. Unexpectedly, after taking four weeks, the subjects’ blood sugar dropped to the level of the group. The subjects had been taking metformin, but the blood sugar was not coming down. Industry sources, the majority of domestic generic drugs are unable to meet the original research standards. In order to pass the review, hide data, abandoned in clinical trials of selective use of data is a very common phenomenon. In this regard, the state launched this year, generic quality and efficacy evaluation of consistency, requirements of chemical generics all approved before October 1, 2007, should complete the conformance assessment before the end of 2018, the need to carry out effective clinical test and there is a special case of the variety, should complete the conformance assessment before the end of 2021; the completion of overdue again, not registered. Bio pharmaceutical XinDa chairman Yu Dechao expects, with generics quality consistency evaluation and effect of development, the existing more than 50% generic drugs will be eliminated, "bad money drives out good money" phenomenon is expected to be initially reversed. Lack of supervision of the intermediary to promote the relevant state departments of clinical fraud 19相关的主题文章: