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Clinical Research Association Distance Education Programs KADUZEM
For Detailed Information
The vaccine candidate is developed by Koçak Pharma. The Primary Investigator is Prof. Dr. Turgay Çelik and the project will be coordinated by Prof. Dr. Aydın Erenmemişoğlu. Phase I will be conducted in Yeditepe University Koşuyolu Hospital Phase I center.
According to an analysis in JAMA, out of 470 Chinese sponsored Randomized clinical trials, 12% of them are published at least twice in other medical journals. This is more prominent if the original study is published in Chinese.
FDA/CDER, approved 53 new drugs in 2020. 58% of the approvals are orphan drugs, 40% first-in-class, and 75% are approved first in USA. CDER approves approximately 40 new drugs each year. 68% of the drugs are approved thorough "Expedited Programs for Serious Conditions".
In the last few years, advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases. Development needs to proceed very quickly to have a chance at helping the individual. FDA is taking the first steps in bringing clarity to this emerging area of individualized drug development by releasing a new draft guidance.
According to an analysis in Nature, COVID-19 pandemic transformed research publishing in 2020.
2 December, 3PM GMT / 11AM EST
John McConnell, Editor, The Lancet Infectious Diseases