06Jun

Since Pfizer launched the first randomized clinical trial to be conducted entirely remotely in 2011, virtual clinical trials have been a trend waiting to happen. Now, prompted by the COVID-19 pandemic, and given the blessing of the FDA, broad acceptance of decentralized trials is becoming a reality.

Writing in the May DIA Global Forum, Dr. Jonathan Cotliar, says that with the impact COVID-19 is having on traditional, face-to-face trials, “Those who were once skeptical of the virtual model are now compelled to embrace it out of necessity.”

As chief medical officer of the virtual clinical trial management company Science 37, Cotliar would be expected to say that. But he’s not alone. Since the beginning of the year, interest in virtual clinical trials has grown; dozens of articles extolling their benefits and predicting their broader adoption have been published.

After the Food and Drug Administration released its “Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” in March, interest in decentralized trials has soared.

The Guidance says that for trials already underway, “Sponsors should determine if in-person visits are necessary to fully assure the safety of trial participants.” The FDA says “sponsors should evaluate whether alternative methods” – among them, virtual visits and phone contact – would be adequate substitutes for in-person contact.

Discussing the FDA guidance, Clinical Leader chief editor Ed Miseta, wrote, “With patients concerned for their health and hesitant about leaving their homes or visiting clinics or hospitals, incorporating virtual aspects into trials may be the only way to ensure their continued participation.”

The clinical news and information portal HCPLive, published a perspective in April pointing out, “The ongoing advancements in cloud, mobile, and IoT, combined with video conferencing and wearables, are opening up unprecedented opportunities for pharma and healthcare, bringing about the evolution of clinical trial management.”

Those technologies writes Daniel Piekarz SVP of Life Sciences & Healthcare at the software development firm, DataArt, will make virtual clinical trials and digital healthcare the “new normal post-COVID-19.”

There are significant benefits to both patients and trial sponsors and managers of virtual trials versus conventional, centralized trials. As Piekarz explains, “Virtual visits and remote patient monitoring in place of mandated in-person site visits gives trial participants a choice as well as the added peace of mind that they won’t be exposed to unnecessary risks. Virtual visits allow sponsors to reach a larger population of participants improving subject recruitment, engagement, and retention.”

Indeed, last month, the managed care company UnitedHealth Group and Yale School of Medicine said they would be launching a virtual study examining the potential role of ACE inhibitors in preventing the severe consequences of COVID-19. The study “Will adopt an innovative, modern approach as one of the first virtual COVID-19 clinical trials to be launched at scale with a suite of digital tools.”

And just last week Reuters reported that LabCorp and software provider Medable will work together “to speed up the adoption of virtual clinical trials, as many participants are dropping out of ongoing studies due to the COVID-19 pandemic.”

Photo by Chris Montgomery on Unsplash

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Jun 6, 2023

What’s the Difference Between the COVID Vaccines?

With the approval last month of the Moderna vaccine by the Food and Drug Administration, we now have two COVID-19 vaccines available. Two more – one from Johnson & Johnson the other from AstraZeneca – are on the way and could be approved as soon as February.

Healthcare workers, residents of nursing facilities and some first responders have already received the Pfizer vaccine, the first one approved by the FDA. Moderna has begun shipping its vaccine with the first of the 25 million initial doses administered last month.

People eager to be immunized have inundated doctors’ offices and clinics asking when the vaccine will be available. The best answer is soon.

Which one, though, will you receive? And does it make any difference?

The answer to the first question is whichever vaccine can be obtained the quickest or, in some cases, whichever your health plan recommends. It really doesn’t make any difference to you.

Both vaccines require two separate doses to reach maximum effectiveness 21 days apart for Pfizer and 28 days for the Moderna version. Both protect about equally well. The FDA data shows Pfizer is 95% effective after both doses. Moderna is 94.1%.

Unlike most other vaccines, these two vaccines use pieces of protein from the SARS-CoV-2 virus to prompt the body to create antibodies. Conventional vaccines, like the annual flu shot, are manufactured from viruses typically grown in chicken eggs. These chicken grown viruses are then killed or weakened to become vaccines.

The COVID vaccines employ messenger RNA (mRNA), a newer technology. These vaccines “teach” the body to replicate the little bit of the CoV-2 protein, which, in turn, creates an immune response causing the body to make the antibodies that provide the protection against the virus.

The most significant difference between the Moderna and the Pfizer vaccines is how they must be stored. Both can survive for a few days in standard refrigeration. For longer periods, the less stable Pfizer vaccine must be kept in ultra-low temperatures below -94 F. That makes shipping and storing Pfizer’s vaccine somewhat more complicated, especially outside urban areas where the low temperature refrigeration is not easily available.

“At the end of the day, these two vaccines are pretty similar,” Dr. Thomas Russo, professor and chief of infectious disease at the State University of New York, tells Health. “Grab it while you can.”

Photo by Hakan Nural

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