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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Green Key

Director of Green Key Pharma Receives RAPS’ Community Leadership Award

Director of Green Key Pharma, Lindsey Summers, is a co-recipient of the Regulatory Affairs Professional Society (RAPS) 2021 Community Leadership Award!

Jun 6, 2023

COVID’s Effects Drag Down Pharma Rankings

In a year of “unparalleled economic and healthcare shocks,” Informa’s Global Pharma Insights says the pharmaceutical industry is still healthy even as “COVID-19’s implications for pharma growth, revenues and the supply chain are still emerging.”

CPhI’s Pharma Industry Rankings & Annual Industry Report 2020 shows how pharmaceutical executives from across the globe assess the state of the industry, ranking the major pharma markets on a range of indicators including growth potential and innovation.

The overall industry index, which is a compilation of the scores across each market, fell for the first time in four years. The index reflects the accumulated scores in five main areas: growth, API manufacturing, finished dose manufacturing, competitiveness, and knowledge of professionals.

While the report doesn’t specifically explain the decline in the overall index, it’s apparent that China’s sharp decline in several categories was a key factor.

“It is China,” the report says, “That has suffered the biggest score decrease of 5.80%, which sees them fall down the rankings into 10th place.” China’s role and its lack of transparency in the early months of the pandemic “has negatively impacted the Chinese pharma market’s reputation in nearly all major sub-sectors,” notes the report, reflecting the views of the survey’s 550 respondents.

However, the report predicts that the effects will be short term. “China’s fundamentals remain too strong. We expect a dramatic bounce for China in 2021.”

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Despite the decline of 7 of the 10 countries detailed in the rankings, the report says “many of the leading pharma economies have scored strongly in knowledge and pharmaceutical quality statistics and much of the fall on 2019 results reflects reduced confidence in growth rather than quality.”

The United States fared well, coming out on top in the CPhI Pharma Index with a score of 7.41. Japan and Germany followed in 2nd and 3rd place. In terms of market growth potential, India was the big winner, coming out on top in rankings for the category for the first time. The country, like China, has long benefited from the outsourcing of high-volume production. This year, as Big Pharma and smaller firms sought to de-risk their global supply chain, India became the primary beneficiary of this rebalancing.

Photo by Isaac Quesada on Unsplash

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