However, a major caveat is that just because a drug or vaccine is deemed a success by receiving FDA approval does not mean it works particularly well. Why would the FDA approve something like that? Because there aren't any good alternatives. For instance, neither the antiviral drug Tamiflu nor the seasonal flu vaccine are particularly impressive. But, there's nothing better available.
The same concern will remain for any approved coronavirus drug or vaccine. We still don't know if humans develop robust, long-lasting immune responses to coronaviruses.
No matter what the FDA says, basic biology ultimately will determine how successful a vaccine is. However, the methodology used by the authors does not necessarily make that true in this case. In a competitive arena, negative results can be a major setback for pharmaceutical companies as well as the patients they ultimately hope to serve.
Another process awaits the drugs that show promise during preclinical lab studies and continue to succeed throughout the phases of clinical testing — thorough vetting by the FDA, specifically the Center for Drug Evaluation and Research CDER.
These thorough applications include safety and efficacy data from all stages of preclinical and clinical trials, proposed labeling, information on potential drug abuse, patent information, data from any studies conducted internationally, information on institutional review board compliance, as well as directions for use. Chin remembered that the ocrelizumab application contained millions of pages of data pulling from studies along each step of the process.
The Standard Review takes about 10 months, while drugs granted Priority Review are fast-tracked to a 6-month time-frame. Priority Review may be granted to drugs that display evidence of effectiveness in treatment, prevention or diagnosis of a condition, that eliminate or reduce a drug reaction, that improve patient compliance leading to improvement in serious outcomes, or that show safety and efficacy in a new subpopulation. Ocrelizumab, with its potential to significantly reduce disability progression in patients with PPMS and relapsing remitting MS, was granted Priority Review in addition to the Breakthrough Therapy designation it had already obtained.
Additionally, for some cases the FDA includes an advisory committee to provide independent assessment of the application. After months of deliberation and input from the team of expert reviewers, the FDA issues either an approval or complete response letter. Drugs may be delayed or denied due to safety issues, a failure to sufficiently prove efficacy, or problems with the drug manufacturing process, which is also inspected by FDA officials.
Once again, however, Chin and the team working on ocrelizumab had reason to celebrate. In the CDER approved 46 novel drugs, over twice the number approved in So far this year, the agency has approved 15 new drugs. Phase I trials carry the most potential risk.
But phase I studies do help some patients. For those with life-threatening illnesses, weighing the potential risks and benefits carefully is key. Sometimes people choose to join phase I trials when all other treatment options have already been tried.
If a new treatment is found to be safe in phase I clinical trials, a phase II clinical trial is done to see if it works in certain types of cancer. The benefit the doctors look for depends on the goal of the treatment. It may mean the cancer shrinks or disappears. In some studies, the benefit may be an improved quality of life.
Many clinical trials look to see if people getting the new treatment live longer than most people do without the treatment. Larger numbers of patients get the treatment in phase II trials, so less common side effects may be seen. Phase III clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment. Because doctors do not yet know which treatment is better, study participants are often picked at random called randomized to get either the standard treatment or the new treatment.
When possible, neither the doctor nor the patient knows which of the treatments the patient is getting. This type of study is called a double-blind study. Randomization and blinding are discussed in more detail later. Nature Reviews , 3, Rho, Jay P. Handbook of Pharmaceutical Biotechnology. New York: Pharmaceutical Products Press, Schacter, Bernice. Biotechnology and Your Health: Pharmaceutical Applications. Philadelphia: Chelsea House Publishers, Speid, Lorna. Oxford: Oxford University Press, Zanders, Edward D.
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