Clinical Trials and Research News Weekly Roundup | Did Donald Trump Participate in REGN-COV2 Trial?

Oct 12, 2020 | Digital NBA, Video, Weekly Roundup

Weekly Roundup TSN


Did President Donald Trump Participe in the REGN-COV2 Trial? Reports were when President Donald Trump was treated for COVID-19 at Walter Reed Medical Center that he received investigational drugs including Regneron’s REGN-CoV2. Of course investigational means that a drug is not approved by the U.S. FDA for a specific indication. Presently REGN-COV2 is only available in a clinical trial with explicit inclusion and exclusion criteria. TrialSite News is not certain that POTUS fit into the study protocol parameters. Did POTUS somehow rapidly get approved to participate or did he secure some kind of compassionate use access to the drug? Apparently, physician Sean Conley released a statement that POTUS received a single 8 gram dose of REGN-COV2 after his positive SARS-CoV-2 diagnosis was acknowledged by the White House Friday.
France-based MedinCell Initiates Ivermectin Clinical Trial Targeting COVID-19 with Prophylactic Strategy: MedinCell treated the first patient in a clinical trial aimed at validating the safety of continuous administration of Ivermectin in an oral form as a prophylactic treatment. Several long-acting injectable formulations based on MedinCell’s BEPO® technology are simultaneously being tested in vivo. The France-based company plans for a 1-month active injectable prophylactic treatment, hopefully for regulatory development before the end of 2020. The company seeks to file for market authorization as early as 2021.
Fake Investigator Going to Prison for 28 Years: Two Washington State Trial Site Operations Duped Sponsors & CRO: Just over a year ago, TrialSite News introduced the exploits of the fake principal investigator named Sani Anwar, owner of what turned out to be illicit trial site operations known as Zain Research and Mid-Columbia Research, to a much wider audience. Industry publications and online media, for the most part, ignored the story. Is it as if the egregious criminal breach raised a collective industry embarrassment? The 41-year-old finally had justice served: 47 counts of fraud and drug-related charges and 28 years in prison. Back in November, TrialSite News reported the defendant was found guilty of defrauding pharmaceutical companies out of several million dollars as they entered into contracts with his deceptive trial site operations for conducting FDA approved clinical trials. Why the pharmaceutical company sponsors or their contract research organizations (CROs) didn’t identify the red flags earlier to stop this fraud cannot be certain. And for that matter, Anwar slipped through cracks as far as FDA scrutiny. Suffice to say some very large and sophisticated pharmaceutical companies, and at least one prominent CRO, as well as regulators were completely duped, and in the process, clinical trial participants were put in harm’s way.


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