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Virtual Clinical Trials: Interview with Ivan Jarry, CEO at ObvioHealth

Decentralized and virtual clinical trials are gaining prominence, particularly since the COVID-19 pandemic which made it difficult for trial participants…

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Decentralized and virtual clinical trials are gaining prominence, particularly since the COVID-19 pandemic which made it difficult for trial participants to attend in-person appointments. However, conducting clinical trials remotely has a host of potential benefits beyond reducing COVID-19 transmission, including improved patient compliance, real-world data, real-time data, and reduced costs.

ObvioHealth is championing this approach to clinical trials, and through a partnership with Renovia, completed the first fully virtual clinical trial in urogynecology, which investigated the leva Pelvic Health System. The leva device is intended to treat female urinary incontinence, and the virtual trial allowed participants to upload data on their symptoms and progress right from their home.

Another aspect of virtual trials is their potential to increase the inclusivity of clinical trials. Women are often underrepresented in clinical trials, in part because of busy lifestyles that lead to recruitment issues. Virtual trials can more easily fit in with other commitments, as they don’t require fixed appointments and allow trial subjects to fit the trial around their lives rather than vice-versa.

Medgadget had the opportunity to speak with Ivan Jarry, ObvioHealth CEO, about virtual trials.      

Conn Hastings, Medgadget: Please give us an overview of virtual clinical trials and their history. Has this approach been in practice for long?

Ivan Jarry, ObvioHealth: The first virtual clinical trial happened in 2011, and was conducted by Pfizer. Until recently though, virtual clinicals trials were more buzz than actual practice. 

When the pandemic hit in early 2020, almost 70% of traditional/on-site clinical trials on a global scale were disrupted or stopped altogether. Since then, the implementation of decentralized clinical trials has accelerated in a dramatic way. An industry initially resistant to change was jolted into recognition of the many benefits of virtualizing clinical trials. This year, decentralized trials will increase by 28% from 2021, which marks a 93% boost from 2020.

ObvioHealth certainly has a place in DCT history. Long before the pandemic, we knew innovation was needed in the clinical research industry, so in 2017 we launched one of the first-ever patient apps for conducting clinical trials at home.

Medgadget: Please speak to the importance of patient compliance in clinical trials. How do virtual trials help to enhance patient compliance?

Ivan Jarry: Compliance helps power a clinical study. If patients don’t comply, the study data loses integrity. If too many patients fall out of compliance, there won’t be sufficient data to prove efficacy. That equals a lot of wasted time and money for clinical trial sponsors.

In a decentralized clinical trial, compliance is often much easier. DCTs reduce the patient burden by allowing them to complete study tasks from home without the need for site visits. Despite the virtual nature of DCTs, patients still require human interaction. ObvioHealth’s COACH (Clinical Oversight and Coordination Hub) team engages with patients through live chat, text, email or phone. This team answers patient questions, helps troubleshoot tech issues and ensures patients are comfortable with the study tasks. If a COACH team member notices a patient who has not completed certain study tasks, the team member can reach out to understand why and encourage the participant to get back on track.

Medgadget: How do virtual trials compare with conventional trials? What are the advantages of the virtual approach?

Ivan Jarry: A traditional trial requires patients to visit clinics for medical assessments and, often to fill out trial diaries on paper.

A virtual, or decentralized, clinical trial removes many or all of those clinic visits and captures data from patients as they go about their daily lives—from the comforts of home. This makes the clinical trial journey much easier for patients, reducing the burden of travel, and thus, as stated above, increasing compliance. But there are many other benefits of collecting data from patients at home, as opposed to inside a clinic. The data from home is more real world, removing any effects from white-coat syndrome. The data is also more real time. Instead of waiting for a site visit to tell a clinician how a patient is feeling, he/she can put the data in the app as symptoms occur.

The advent of new digital devices and instruments is now providing a growing number of opportunities to integrate technology into decentralized studies in ways that were previously impossible. These devices can capture vitals, symptoms and other signals from the comfort of home, improving outcome accuracy. They are also opening up the possibility for new endpoints to progress research. ObvioHealth is currently working with partners to develop digital instruments that are capturing real coughing, crying, breathing events as well as skin images and uploading them through our app. Previously, the only option was to rely on patient reporting or oblige them to go to a site to be ‘assessed’.

Medgadget: What inspired you to establish ObvioHealth? 

Ivan Jarry: Traditional clinical trials are slow, expensive and often fail to reach completion. I co-founded ObvioHealth in 2017 to leverage technology as a way to address these inefficiencies with the goal of providing a seamless trial experience for the patient. The founding of the company pre-dated the pandemic because we saw how the digital frontier was changing healthcare and we saw the need for a similar transformation in clinical research. We knew that with patients’ consent, we could tap into a wealth of resources and data through their smartphones, using these as an effective tool to rethink the way we do research. The result has been trials that are faster, easier and more accurate.

Medgadget: Please give us an overview of your recent trial of Renovia’s leva Pelvic Health System.

Ivan Jarry: Through our partnership with Renovia, we conducted the first ever fully virtual clinical trial in urogynecology. We knew a decentralized study design could overcome barriers on an often “taboo” subject: incontinence in women. Incontinence affects 62% of adult women in the U.S. This groundbreaking study tested the efficacy of an at-home medical device against a control group. The women in the study used the device and recorded each time they went to the bathroom or had a leak in the ObvioHealth app. Among the many study achievements were high compliance- even among an older patient population – and lower costs.

Medgadget: Do you think that decentralized and virtual trials will help to increase the representation of women’s health issues in clinical trials?

Ivan Jarry: With the exception of breast cancer research, women’s health issues are unfortunately under-represented in clinical trials. Women are busy, and just like we saw during the height of the pandemic, they often juggle careers, motherhood, finances, etc., leaving little time for their own health and wellness. But this is no excuse for the industry to ignore this cohort. As we turn toward a more virtual future, decentralized clinical trials can provide trial access to women in an easier way to capture this crucial data. Hopefully, this will encourage trial sponsors to commit to more research on women’s issues – such as incontinence, fertility, maternal health, menopause, endometriosis and many other issues. We have already successfully completed several decentralized trials in women’s health, and we’re quite proud to be a part of such important research.

Link: ObvioHealth homepage…

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Cruise Line Drops Pre-Cruise Covid Testing Rule

The major cruise lines walk a delicate line. They need to take the actual steps required to keep their passengers safe and they also need to be aware of…

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The major cruise lines walk a delicate line. They need to take the actual steps required to keep their passengers safe and they also need to be aware of how things look to the outside public. It's a mix of practical covid policy balanced with covid theater.

You have to do the right thing -- and Royal Caribbean International (RCL) - Get Royal Caribbean Group Report, Carnival Cruise Lines (CCL) - Get Carnival Corporation Report, and Norwegian Cruise Lines (NCLH) - Get Norwegian Cruise Line Holdings Ltd. Report have been doing that with very meticulous protocols-- but you also have to show the general public you're taking the pandemic seriously. The cruise industry has been under the microscope of both public perception and the Centers for Disease Control (CDC) since covid first appeared.

That's not because you're likely to get infected on a cruise ship than at a concert, sporting event, theme park, restaurant, or any other crowded space. It's because when you get sick at one of those locations nobody can pinpoint the source of your infection

Cruises last from 3 days to 7 days or even longer and that means that some people will get covid onboard and that will be blamed on the cruise industry. To mitigate that Carnival, Royal Caribbean, and Norwegian have rigid protocols in place that require passengers 12 and over to be vaccinated as well as pre-cruise covid tests taken no more than two days before your cruise leaves.

Once cruise line has dropped that testing requirement (at least on a few sailings) and that could lead Royal Caribbean, Carnival, and Norwegian to follow. 

Sina Schuldt/picture alliance via Getty

Holland America Drops Some Covid Testing

As the largest cruise lines sailing from the U.S., Royal Caribbean, Carnival, and Norwegian don't want to be the first to make major covid policy changes. They acted more or less in tandem when it came to loosening, then dropping mask rules and have generally followed the lead of the CDC, even when that agency's rules became optional.

Now, Holland America cruise line has dropped pre-cruise covid testing on a handful of cruises. It's a minor move, but it does provide cover and precedent for Royal Caribbean, Carnival, and Norwegian to eventually do the same.

"Holland America Line becomes the first US-based cruise line to remove testing for select cruises. Unfortunately for those taking a cruise from the United States, the new protocols are only in place for certain cruises onboard the company’s latest ship, the Rotterdam, in Europe," Cruisehive reported.

The current CDC guidelines do recommend pre-cruise testing, but the cruise lines into following those rules. By picking cruises sailing out of Europe, Holland America avoids picking a fight with the federal agency just yet, but it will be able to gather data as to whether the pre-cruise testing actually helps.

Holland America has not changed its vaccination requirements for those cruises which mirror the 12-and-up rule used by Royal Caribbean, Carnival, and Norwegian.

Some guests have called for the end of the testing requirement because they believe it's more theater than precaution because people can test and then contract covid while traveling to their cruise.

The Current Cruise Protocols Work

Royal Caribbean President Michael Bayley does expect changes to come in his cruise line's covid protocols, and he talked about them during Royal Caribbean's recent President's Cruise, the Royal Caribbean Blog reported.

"I think pre cruise testing is going to be around for another couple of months," Bayley told passengers during a question and answer session. "We obviously want it to go back to normal, but we're incredibly cognizant of our responsibilities to keep our crew, the communities and our guests safe."

People do still get covid onboard despite the crew being 100% vaccinated and all passengers 12 and over being vaccinated, but the protocols have worked well when it comes to preventing serious illness.

Bayley said that the CDC shared some information with him in a call.

"The cruise industry sailing out of the US ports over the past 12 months and how many people have been hospitalized with Covid and how many deaths occurred from Covid from people who'd sailed on the industry's ships, which is in the millions," he said, "And the number of people who died from COVID who'd sailed on ships over the past year was two."

That success may be why the major cruise lines are reluctant to make changes. The current rules, even if they're partially for show, have been incredibly effective.

"Two is terrible. But but but against the context of everything we've seen, that's it's truly been a remarkable success." he added.

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Visualizing A Decade Of Population Growth And Decline In US Counties

Visualizing A Decade Of Population Growth And Decline In US Counties

There are a number of factors that determine how much a region’s population…

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Visualizing A Decade Of Population Growth And Decline In US Counties

There are a number of factors that determine how much a region’s population changes.

If an area sees a high number of migrants, along with a strong birth rate and low death rate, then its population is bound to increase over time. On the flip side, as Visual Capitalists Nick Routley details below, if more people are leaving the area than coming in, and the region’s birth rate is low, then its population will likely decline.

Which areas in the United States are seeing the most growth, and which places are seeing their populations dwindle?

This map, using data from the U.S. Census Bureau, shows a decade of population movement across U.S. counties, painting a detailed picture of U.S. population growth between 2010 and 2020.

Counties With The Biggest Population Growth from 2010-2020

To calculate population estimates for each county, the U.S. Census Bureau does the following calculations:

      A county’s base population → plus births → minus deaths → plus migration = new population estimate

From 2010 to 2020, Maricopa County in Arizona saw the highest increase in its population estimate. Over a decade, the county gained 753,898 residents. Below are the counties that saw the biggest increases in population:

Phoenix and surrounding areas grew faster than any other major city in the country. The region’s sunny climate and amenities are popular with retirees, but another draw is housing affordability. Families from more expensive markets—California in particular—are moving to the city in droves. This is a trend that spilled over into the pandemic era as more people moved into remote and hybrid work situations.

Texas counties saw a lot of growth as well, with five of the top 10 gainers located in the state of Texas. A big draw for Texas is its relatively affordable housing market. In 2021, average home prices in the state stood at $172,500$53,310 below the national average.

Counties With The Biggest Population Drops from 2010-2020

On the opposite end of the spectrum, here’s a look at the top 10 counties that saw the biggest declines in their populations over the decade:

The largest drops happened in counties along the Great Lakes, including Cook County (which includes the city of Chicago) and Wayne County (which includes the city of Detroit).

For many of these counties, particularly those in America’s “Rust Belt”, population drops over this period were a continuation of decades-long trends. Wayne County is an extreme example of this trend. From 1970 to 2020, the area lost one-third of its population.

U.S. Population Growth in Percentage Terms (2010-2020)

While the map above is great at showing where the greatest number of Americans migrated, it downplays big changes in counties with smaller populations.

For example, McKenzie County in North Dakota, with a 2020 population of just 15,242, was the fastest-growing U.S. county over the past decade. The county’s 138% increase was driven primarily by the Bakken oil boom in the area. High-growth counties in Texas also grew as new sources of energy were extracted in rural areas.

The nation’s counties are evenly divided between population increase and decline, and clear patterns emerge.

Pandemic Population Changes

More recent population changes reflect longer-term trends. During the COVID-19 pandemic, many of the counties that saw the strongest population increases were located in high-growth states like Florida and Texas.

Below are the 20 counties that grew the most from 2020 to 2021.

Many of these counties are located next to large cities, reflecting a shift to the suburbs and larger living spaces. However, as COVID-19 restrictions ease, and the pandemic housing boom tapers off due to rising interest rates, it remains to be seen whether the suburban shift will continue, or if people begin to migrate back to city centers.

Tyler Durden Sat, 07/02/2022 - 21:00

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Tesla EV deliveries fall nearly 18% in second quarter following China factory shutdown

Tesla delivered 254,695 electric vehicles globally in the second quarter, a nearly 18% drop from the previous period as supply chain constraints, China’s…

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Tesla delivered 254,695 electric vehicles globally in the second quarter, a nearly 18% drop from the previous period as supply chain constraints, China’s extended COVID-19 lockdown and challenges around opening factories in Berlin and Austin took their toll on the company.

This is the first time in two years that Tesla deliveries, which were 310,048 in the first period this year, have fallen quarter over quarter. Tesla deliveries were up 26.5% from the second quarter last year.

The quarter-over-quarter reduction is in line with a broader supply chain problem in the industry. It also illustrates the importance of Tesla’s Shanghai factory to its business. Tesla shuttered its Shanghai factory multiple times in March due to rising COVID-19 cases that prompted a government shutdown.

Image Credits: Tesla/screenshot

The company said Saturday it produced 258,580 EVs, a 15% reduction from the previous quarter when it made 305,407 vehicles.

Like in other quarters over the past two years, most of the produced and delivered vehicles were Model 3 and Model Ys. Only 16,411 of the produced vehicles were the older Model S and Model X vehicles.

Tesla said in its released that June 2022 was the highest vehicle production month in Tesla’s history. Despite that milestone, the EV maker as well as other companies in the industry, have struggled to keep apace with demand as supply chain problems persist.

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