{"id":10674,"date":"2020-11-18T19:35:53","date_gmt":"2020-11-18T19:35:53","guid":{"rendered":"https:\/\/blogs.cooperhealth.org\/ehealth\/?p=10674"},"modified":"2020-11-19T23:38:33","modified_gmt":"2020-11-19T23:38:33","slug":"understanding-clinical-trails-and-the-covid-19-vaccine","status":"publish","type":"post","link":"https:\/\/blogs.cooperhealth.org\/ehealth\/2020\/11\/18\/understanding-clinical-trails-and-the-covid-19-vaccine\/","title":{"rendered":"Understanding Clinical Trials and the COVID-19 Vaccine"},"content":{"rendered":"

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Recent public announcements by both Pfizer and Moderna suggest that vaccines for COVID-19 developed by these companies may be approved by the United States Food and Drug Administration (FDA) in the next several weeks.<\/p>\n

Since the first case of COVID-19 was reported in China almost a year ago, the objective of the global scientific and medical community has been on the development of standard therapeutics to treat the virus as well as a vaccine to provide individuals with immunity.<\/p>\n

Many pharmaceutical companies are making promising progress with their research. It is important to understand how this scientific research is done and how clinical trials work in developing new drugs or vaccines for COVID-19.<\/p>\n

Why are clinical trials necessary?<\/strong><\/p>\n

Clinical trials are vital to help ensure new treatments and vaccines are safe for humans. They help clinicians determine how much of the product to prescribe and when, what side effects to expect, and which patients will likely benefit the most from the treatment or vaccine. Many drugs and treatments reach clinical trials, but never reach the public because they don\u2019t work or they are harmful. This process reduces the risk of treatments coming to market that are not helpful or that are harmful.<\/p>\n

During the pandemic, there was a lot of discussion about using drugs approved for other diseases to treat COVID-19 without clinical trials having shown benefit and safety. Is this a good idea?<\/strong><\/p>\n

\u201cIn the face of a pandemic as widespread, impactful, and potentially deadly as COVID-19 there was public pressure for physicians to administer medicines for COVID-19 that are\u00a0approved for other diseases but with unknown benefit or even potential harm,\u201d said R. Phillip Dellinger, MD, MSc, MCCM,\u00a0 Professor of Medicine at Cooper Medical School of Rowan University. \u201cWithout meaningful studies, the medical community has no way of knowing if these medicines worked or not, or even if the patients simply recovered on their own with supportive care. Ideally, all of these unproven medications should be administered as part of a randomized clinical trial, as we do as a matter of routine research practice in normal times. Only then can we evaluate the safety and efficacy of these drugs or interventions.\u201d<\/p>\n

Why do clinical trials seem to take so long?
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Clinical trials involve a series of methodical phases, according to Raquel Nahra, MD, infectious diseases specialist at Cooper. \u201cDifferent vaccines have been developed and are currently enrolling volunteers around the world. The results of those trials are essential as part of management of one the worst public health crises that we have faced in over a 100 years.\u201d<\/p>\n

Below are the five phases of a clinical trial:<\/p>\n