The Food and Drug Administration once said that “subjects should not be recruited through press conferences.” Academician: A joke! -Health without instant news



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Wu Xiumei said yesterday that the three domestic companies currently developing Wuhan pneumonia, including Guoguang Biotechnology, United Asia Biotechnology and high-end vaccines, have entered the first phase of clinical trials. (Provided by the command center)

[Canal de salud / Informe completo]At a press conference yesterday (11) by the Epidemic Central Command Center, the Director of the Food and Drug Administration and the deputy head of the R&D team Wu Xiumei announced that the national research and development of pneumonia of Wuhan (novel coronavirus disease, COVID-19) Three of the companies, including Guoguang Biotechnology, United Asia Biotechnology and high-end vaccines, have entered phase 1 clinical trials. To accelerate phase 2 clinical trials, it has been established and opened a “COVID-19 vaccine clinical trial intention registration platform”. The public registered as subjects.

Liu Hongen, a member of the Human Body Research Ethics Review Committee at the Department of Health and Welfare and an associate professor at Chengchi National University School of Law, wrote on Facebook that the Food and Drug Administration had issued a letter in 2018 stating that the recruitment of subjects for clinical drug trials should not be based on reporters. Recruit subjects in the form of an encounter. He criticized “everyone who ever believed, everyone is a joke.”

This letter is understood to be a response from the Food and Drug Administration to the ROC Pharmaceutical Research Association’s inquiry on “Principles of Recruitment for Clinical Drug Trials.

According to the content of the letter, the ROC Pharmaceutical Research Association for Development asked: “With the advancement of science and technology, the media has become more diversified and the changes in communication methods have also become more diverse. have accelerated the speed of communication.If the recruitment ad can be run in print ads, electronic media Compared with social media sites, it is expected to have a better recruiting effect.Is it appropriate for recruitment ads to run in print ads, electronic media, or social networking sites? “

The Food and Drug Administration responded to 3 points of explanation, of which the second point is “In addition, the standard of the Medical Letter of the Department of Health No. 0990264204 of October 11, 1999 and the Letter of the Department of Health No. . 0991413169 of October 21, 1999, subjects Recruitment methods and content must be reviewed and approved by the Human Testing Committee before being published, and subjects must not be recruited under the guise of job search or press conferences. “

Liu Hongen previously said in a Facebook post that there is a joke: an excerpt from the Food and Drug Administration of the Ministry of Health and Welfare, FDA No. 1070014500 of July 9, 107, “Subjects should not be recruited into conferences press “. He directly noted that “everyone who ever believed, everyone is a joke.

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