Comments by "Banana" (@439bananas) on "Dr. John Campbell" channel.

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  2. The normal process of clinical trials involves a lot of faffing around as tests are run in series rather than in parallel so that investors get maximum value. So they generally go something like this: 1] Someone finds a possible drug in a lab and lots of chemical tests are run to prove that it is a possible drug. The results are presented to investors to get funding for the next stage. 2] Company gets funding for the next stage, they then have to go to the Human Tissue Authority to get tissue culture tests signed off so that they can get their hands on spare human tissues from procedures such as circumcision, abortions, amputations, removed teeth etc. Can be a lot of toing and froing while experimental design is approved by HTA. 3] Tests are performed in tissue culture, this takes time due to its laborious nature. Results are collated and presented to the investors for the next tranch of money. 4] Money comes in and the drug can move into animal testing in rodents to start with, but your experimental design has to be licensed by the Home Office and this takes time. This establishes a lethal dose 50 figure and helps establish dose and establishes effectiveness in an animal model 5] then it can move into primate testing to refine likely dose further and to look for potential adverse reactions, but it all has to be approved by the Home Office and a license given for every stage. 6] Assuming success it will then be back to investors with the results for more money to run human trials and then it will be off to the ethics committees to approve a human trial in healthy humans to establish the safety and side effects of the drug and in the case of a vaccine then antibody titres and epitope specificity would be part of this testing. 7] Assuming the drug looks OK then it is back to the investors and then on to the ethics committee to run a trial in affected patients. In the case of the vaccine it would be to administer the vaccine and then deliberately infect the test subjects to see if it works. All of this usually takes 8-12 years. Time that we do not have. So governments have stepped in and have funded this getting rid of the normal funding rounds. Stages 1-5 have been able to run largely in parallel as ethics committees have been told to allow this stuff to run. The human trials will have been subject to rigorous scrutiny, but the ethics committees will have been told to prioritise the vaccine ahead of any other drugs that are in the pipeline. They have simply dispensed with a lot of the faffing around that goes on with normal drug development.
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