Author: Raymond McBride

The Role of Retail Pharmacies in the Evolving Landscape of Clinical Research

The Role of Retail Pharmacies in the Evolving Landscape of Clinical Research
The world of clinical research is constantly evolving, and one of the most significant shifts in recent years has been the entrance of retail pharmacies into the space. Companies like CVS, Walgreens, Walmart, and Kroger have become leaders in retail clinical research, offering patients more convenient access to clinical trials. However, while these companies benefit the clinical research space, there are some concerns.

CVS has emerged as a leader in the retail clinical research space, with around 100 Minute Clinics that can support clinical research, and has extensive patient and claims data, which can be used to conduct outreach to patients interested in participating in clinical research, and support protocol optimization. The convenience of these locations makes clinical research more accessible to patients, especially those living far from academic medical centers and lacking easy access to clinical trials.

The emergence of retail pharmacies has the potential to make clinical trials more diverse and accessible. These companies can help recruit more diverse and local patient populations by reaching out to patients directly, which is critical as clinical trial populations have historically been skewed toward specific demographics and supplement patient diversity by going global rather than ensuring local patient representation. Additionally, real-world evidence data from pharmacies can be used to design more thorough protocols and studies; biopharmaceutical companies are analyzing patient data using machine learning algorithms to design better studies.

However, despite the potential benefits of retail pharmacy clinical research, patient participation in clinical trials remains low, with only 3{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of patients participating in trials (as mentioned by Debbie Profit, Vice President, Clinical Management and Applied Innovation at Otsuka Pharmaceuticals at SCOPE). One of the reasons for this is the inconvenience of clinical trials, with patients having to take time off work, travel to the clinic, and deal with other burdensome requirements. To address this, the industry must focus on making clinical trials more convenient for patients by offering remote participation options and flexible scheduling.

Josh Rose, VP, Head of Clinical Trial Delivery, Site Solutions, and Strategy at CVS, presented the results of a survey CVS conducted on patients at SCOPE 2023, indicating that patients prefer decentralized clinical trial methods, such as having a study site close to their homes, appointment flexibility, and telehealth study visits.

Sid Jain Johnson, Head, Global Development Data Science Strategy & Portfolio at Janssen, emphasized the industry’s recognition of patient burden and the need for change at SCOPE. He shared his experience driving an hour each way to see a specialist and how it deters him from participating in trials. He believes that the industry is acknowledging this challenge and working towards making clinical trials more patient-centered.

Another potential benefit of retail pharmacies in the clinical research space is the ability to offer more personalized care to patients. Retail pharmacists are often the first point of contact for patients seeking medical advice and can play a critical role in identifying potential clinical trial candidates. By working closely with clinical trial teams, retail pharmacists can help ensure patients receive the necessary information and support to participate in clinical trials. This personalized approach to patient care can help build trust and improve patient outcomes, ultimately benefiting the entire healthcare system.

The role of retail pharmacies in the evolving landscape of clinical research is not without controversy. For example, the fact that these enterprises are new at clinical trials brings clinical trial quality oversight and data quality concerns that could compromise the safety and efficacy of new treatments. There are also concerns about potential conflicts of interest, as retail companies have a financial stake in revenue generation since they’re publicly held and may compromise patient safety or data quality for financial gain; alternatively, privately-held study sites may focus less on finances and more on conducting quality clinical trials. While retail pharmacies can help recruit diverse patient populations, barriers to participation still need to be addressed, such as patient burden and the inconveniences stemming from poor protocol design, a sponsor’s responsibility.

In summary, retail pharmacies like CVS, Walgreens, Walmart, and Kroger have the potential to transform the clinical research industry by offering more convenient access to clinical trials and helping to recruit diverse patient populations. However, the industry must address the patient burden by providing more convenient and accessible options to increase patient participation. The quality of data collected in these settings and potential conflicts of interest must also be addressed to ensure patient safety and data integrity. By doing so, clinical trials can become more representative of the patient population, leading to better treatments and medications.

Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and regular contributor to Applied Clinical Trials.

How major retailers are trying to change how America consumes health care

Illustration of a price tag in the shape of a red cross

Illustration: Sarah Grillo/Axios

Amazon, Walmart, CVS, Dollar General and other big retailers are elbowing their way into health care delivery, pushing a customized consumer experience driven by digital health products.

What’s happening: At its core, these companies are pulling together different tech-enabled services — urgent, primary, home and specialty care, pharmacy, and, in some cases, full integration with an insurer.

  • “Convenience is really front and center to those plays. They are trying to capture the attention of the patient when they already own that consumer,” Caroline Hofmann, head of emerging businesses at virtual specialty care company Thirty Madison.

Why it matters: A more user-friendly portal to the health system could lead to more engaged patients and better access to care in underserved areas. It could even yield a sustainable model for profitably offering better care for less money.

  • But the retailers’ forays are prompting growing anti-trust and privacy concerns, as well as fears of further erosion of the doctor-patient relationship once considered central to coordinated care.

What they are saying: “If you fast forward 10 years from now, people are not going to believe how primary care was administered,” said Amazon CEO Andy Jassy in a recent announcement about the company’s $3.9 billion acquisition of concierge medicine provider One Medical.

  • With that deal, which closed last month, Amazon brought in an on-demand virtual care services platform, more than 125 locations and a piece of the Medicare Advantage business.

Driving the news: Yesterday, Best Buy Health launched a hospital-at-home program with North Carolina-based Atrium Health. The tech retailer bought the remote patient monitoring company Current Health in 2021. Best Buy said it will provide patient education, its at-home care platform and devices, and technical support via specially-trained Geek Squad agents.

  • It came on the heels of Walmart Health announcing last week that it plans to nearly double the footprint of its in-store clinics, which offer primary, behavioral health vision and dental care. In the fall, Walmart also inked a 10-year Medicare Advantage deal with UnitedHealth Group.
  • In January, CVS Health announced a plan to buy Oak Street Health, a primary care group focused on Medicare patients. The pharmacy giant already owns insurer Aetna, pharmacy benefit manager CVS-Caremark, home health company Signify Health and health care service brands MinuteClinic and HealthHUB.
  • Also in January, Walgreens-backed primary care company VillageMD, scooped up more primary, specialty and urgent care investments, augmenting plans to open more than 500 full-service doctors’ offices in Walgreens locations,
  • Other companies like Rite Aid, Albertson’s, and Dollar General have launched programs in health care delivery.

Between the lines: Amazon, CVS and Walmart have made some of the most consequential moves by combining their massive retail footprints with assets like primary or urgent care sites, pharmacies and some sort of relationship with insurers, experts say.

  • “They’re all acquiring every piece of medicine,” Robert Pearl, a Stanford University professor and former CEO of The Permanente Medical Group, told Axios.
  • “Medicine as we know it will be very very different assuming they’re successful. They’re big companies, they’re smart companies.”

Be smart: Depending on the retailer, patients might have access to virtual care services, book appointments and fill prescriptions via an app.

  • They could get same-day care, get preventative services like vaccines and pick up their drugs in-store. A health worker might walk them down store aisles and guide them to healthy food purchases and wellness products.

In the first wave of this trend, retailers were more focused on urgent care or one-off visits for vaccines, said Jacob Effron, a principal at Redpoint Ventures.

  • “The criticism that could’ve been levied at that is that patients could just go for that ad hoc care and not have an ongoing relationship with a primary care doctor,” he said.
  • In recent months, retailers are investing in end-to-end primary care. “That’s what gets me increasingly excited about their role because there’s only so much you can do as the urgent care provider and much much more you can do when you have that longitudinal relationship between the doctor and a patient over time,” Effron said.

Between the lines: Each of these businesses also are clearly eyeing a very lucrative segment of health care: Medicare Advantage. More than half of eligible seniors are now covered by privately-run Medicare.

  • Medicare Advantage is attractive because its payment models are geared toward rewarding providers for wellness and prevention care. Payments are capped so there’s an incentive to use integrated care to keep people healthy rather than providing services when they are sick.
  • For some retailers, it’s similar to the Kaiser Permanente model, where the payer and provider are completely aligned, Pearl said. But the retailers could create an HMO on steroids.
  • “Why has Kaiser Permanente never really expanded nationally? It’s very hard to get enough of a population in a local area to provide it. You can’t hire enough specialists, enough doctors,” he said. “The beauty of the retail giants is how big they are. If you get every Amazon Prime member to join, they immediately have enough volume they need to put in place a high-functioning system.”

What to watch: How these businesses evolve.

  • Amazon until now has been mostly virtual in its offerings, Effron said. “It begs the question, will they do a similar model to what some of these others have done and put clinics in Whole Foods?”

The bottom line: This still makes up a very small segment of health care delivery — and may not solve the medical system’s biggest problems.

  • “These players ultimately have to deliver the same or better outcomes at a lower cost in order to be in-network and get recommended by payers as well as picked by the employers,” Hofmann said.
  • And, she said, they can certainly increase access. “It remains to be seen if they can really bend the cost curve,” she said.

Editor’s note: This story has been updated to correct the spelling of Caroline Hofmann’s name.

4 tips to boost your family’s nutrition and fitness this spring

(BPT) – With warmer weather just around the corner, it’s the perfect time for you and your family to spring into action and really hone in on overall nutrition and wellness. Not sure where to start? Registered Dietitian and Nutritionist Dawn Jackson Blatner shares easy ways to elevate your family’s goals! From fun physical activities you can do together, to healthy habits you can implement today, you won’t believe how these simple tips will impact positive change in your family!

1. Make the most of longer days and get active

As spring extends daylight hours, it’s easier for families to get outside and get moving, which allows you to enjoy even more quality time together! Blatner suggests adding a family bike ride, a neighborhood walk or an outdoor game to your after-dinner routine to promote physical activity. Need new ideas to encourage outdoor play with youngsters? Try creating a backyard obstacle course, relay race or nature scavenger hunt.

2. Prep for better sleep with pre-bedtime habits

Springtime, especially with Daylight Saving Time, can wreak havoc on your regular sleep schedule. If you plan ahead, however, good nighttime habits can improve relaxation, so the whole family can get a better night’s sleep.

You can encourage prep for rest by shutting down electronics an hour before bedtime and keeping phones and other devices out of kids’ bedrooms. This can help everyone to wind down and fall asleep faster at night, while lessening screen time.

3. Spring clean and organize your kitchen

The spring is a great time of year to de-clutter and sanitize your household, as a thorough cleaning can help reduce the levels of allergens, bacteria and viruses that could be present in your home. Blatner recommends starting with the most frequently used rooms first, like the kitchen.

By cleaning out and reorganizing your fridge and pantry, you can choose to put wholesome ingredients like fresh fruits and veggies, nuts, beans, oats, avocado and eggs at eye level. When meal-prepping for the school week ahead, you’ll tend to grab these foods more often and guarantee your kids will be getting in their nutrition.

4. Amp up your family’s nutrition with fun recipes

Make it a family goal to try a new recipe each week, with a focus on incorporating nutrient-packed ingredients. Whether it’s breakfast, lunch, dinner or snack time, make sure you’re choosing wholesome ingredients like Eggland’s Best eggs, which have more than six times the Vitamin D and double the Omega-3s and Vitamin B12 compared to ordinary eggs.

Check out these Oatmeal Snack Bars from Eggland’s Best! It’s a delicious and easy recipe that provides a quick boost of energy in the mornings, or can be eaten on the go to support your family’s overall wellness and nutrition.

Oatmeal Snack Bars
Prep time: 5 minutes
Cook time: 25 minutes
Yield: 16 bars

Ingredients

  • 2 Large Eggland’s Best eggs
  • 1 mashed ripe banana (about 1/2 cup)
  • 1/4 cup maple syrup
  • 1 teaspoon vanilla extract
  • 2 cups rolled oats
  • 1/2 cup almond flour (or whole wheat flour)
  • 1/4 cup mini dark chocolate chips
  • 1 teaspoon baking powder
  • 1/2 teaspoon sea salt
  • 1/2 teaspoon cinnamon

Preparation

1. Preheat oven to 350 degrees F.
2. In bowl, whisk Eggland’s Best eggs, mashed banana, maple syrup and vanilla.
3. In another bowl, mix together oats, flour, chocolate chips, baking powder, salt and cinnamon.
4. Add egg mixture (wet ingredients) to the oat mixture (dry ingredients) and stir.
5. Spread batter into an 8×8 baking pan lined with parchment paper.
6. Bake for about 25 minutes, or until set in middle and golden around edges.
7. Let cool and cut into 16 squares.

Kick off the spring season right!

Eggland’s Best has teamed up with the YMCA to encourage families to improve their overall nutrition and wellness routine. From now until May 5th, enter the “Recipe for a Healthy Family” Sweepstakes daily for a chance to win the Grand Prize of $5,000, a $250 grocery store gift card and more! Visit EBFamilySweeps.com for Official Rules and how to enter.

Is EU MDR harming medical device innovation?

Is EU MDR harming medical device innovation?
Image credit: John Lamb/Getty Images

The extensive technical documentation requirements of the EU’s Medical Device Regulation (EU mDR) are curbing opportunities for early device development according to industry leaders.

At the Outsourcing In Clinical Trials: Medical Devices Europe 2023 meeting on February 21-22, Philips clinical project manager Deborah Ann Schuster shared some of the pain points that companies are encountering since implementation of the new rules.

In addition to time and resource constraints, Schuster said physicians and SMEs are disincentivised to begin prototype testing and trials due to the huge increases in technical documentation required by the EU MDR.

“Before the MDR was implemented, the key innovators of medical devices were able to easily set up an investigator-initiated trial,” said Schuster. “But now the requirements for the submission of technical documentation to begin these trials is way more challenging. EU MDR requires the innovators to prepare time-consuming documentation and they need much more manpower and funding to comply with the regulations.”

As most device innovation comes from startups or research groups, Schuster explained that this is having a negative impact on the large companies.

“The drivers of innovation are often the potential users, meaning physicians and physician researchers. They come up with the idea for a new device, or suggestions to improve existing devices and often those researcher physicians are the ones who develop the first prototypes. So, one of big challenges we are seeing with the MDR is in innovation of novel devices.”

To navigate these challenges, Schuster said some companies are looking for alternatives, including leveraging flexibility within different EU competent authorities.

In Slovenia, an infrastructure of CROs and trial sites is building for early development studies as the country has some flexibility compared to other.

However, other companies are looking further afield and opting to leave Europe for the US, she added.

“I assume that many companies will move to the US because prototype innovation and testing is way easier than it is here. For our Munich Philips team this is not an option because shipping outside of Europe for a second prototype will make our studies even more complex, but for other companies, it could be an option. But what we want here in Europe is to keep the innovation and keep the early development where it has been invented.”

The EU MDR and IVDR regulations became effective in May 2017 but have become applicable over a transition period, to allow time for companies to acclimate to the new requirements. In , the European Commission implemented a proposal to extend the transitional period to certify medical devices under the MDR. The proposal allows more time for manufacturers to transition from the previously applicable rules to the new requirements.

For high-risk devices, the transition period to the new rules will be shorter (extended to December 31, 2027), whereas the medium and lower risk devices will have a longer transition period (extended to December 31, 2028). The proposal also introduces a transition period for Class III implantable custom-made devices. Manufacturers will have until May 26, 2026, to certify such devices.

Supply chain, operations, outsourcing and other key topics will be discussed with industry experts and leading speakers at Arena International’s upcoming Clinical Trials events across the globe.

Seven Healthy Habits To Reduce the Risk of Dementia

Alzheimer’s Disease Brain Treatment

New research spanning two decades has found that following seven healthy habits and lifestyle factors, known as the American Heart Association’s Life’s Simple 7, may lower the risk of dementia in women. These factors include being active, eating better, maintaining a healthy weight, not smoking, maintaining healthy blood pressure, controlling cholesterol, and having low blood sugar.

New research that followed female participants for two decades has found that seven healthy habits and lifestyle factors may play a role in lowering the risk of dementia. The preliminary study released on February 27, 2023, will be presented at the American Academy of Neurology’s 75th Annual Meeting being held in person in Boston and live online from April 22-27, 2023.

The seven cardiovascular and brain health factors, known as the American Heart Association’s Life’s Simple 7, are: being active, eating better, maintaining a healthy weight, not smoking, maintaining a healthy blood pressure, controlling cholesterol, and having low blood sugar.

“Since we now know that dementia can begin in the brain decades before diagnosis, it’s important that we learn more about how your habits in middle age can affect your risk of dementia in old age,” said Pamela Rist, ScD, of Brigham and Women’s Hospital in Boston, Massachusetts, and a member of the American Academy of Neurology. “The good news is that making healthy lifestyle choices in middle age may lead to a decreased risk of dementia later in life.”

AHA Life's Simple 7

The American Heart Association’s Life’s Simple 7 is a set of health goals designed to help people improve their overall health and reduce their risk of heart disease, stroke, and other chronic conditions. These seven goals include:

  1. Manage blood pressure: Keeping your blood pressure within a healthy range can reduce your risk of heart disease and stroke.
  2. Control cholesterol: High levels of cholesterol in the blood can increase your risk of heart disease.
  3. Reduce blood sugar: High blood sugar levels can increase your risk of developing type 2 diabetes and other chronic conditions.
  4. Get active: Regular physical activity can improve your overall health and reduce your risk of chronic conditions.
  5. Eat better: A healthy diet can reduce your risk of chronic conditions and improve your overall health.
  6. Lose weight: Maintaining a healthy weight can reduce your risk of chronic conditions and improve your overall health.
  7. Stop smoking: Quitting smoking can reduce your risk of heart disease, stroke, and other chronic conditions.

By focusing on these seven goals, individuals can make positive lifestyle changes that can lead to better health outcomes and a lower risk of chronic conditions.

The study involved 13,720 female participants with an average age of 54 at the start of the study.

After 20 years of follow-up, researchers looked at Medicare data to identify those who had been diagnosed with dementia.

Of the participants, 1,771, or 13{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}, developed dementia.

For each of the seven health factors, participants were given a score of zero for poor or intermediate health and one point for ideal health, for a total possible score of 7. The average score was 4.3 at the start of the study and 4.2 10 years later.

After adjusting for factors like age and education, researchers found that for every increase of one point in the score, a participant’s risk of dementia decreased by 6{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}.

“It can be empowering for people to know that by taking steps such as exercising for half an hour a day or keeping their blood pressure under control, they can reduce their risk of dementia,” Rist added.

A limitation of the study was that researchers were unable to look at how changes in factors such as quitting smoking influenced the risk of dementia later in life.

The study was supported by the National Institutes of Health.

Intermountain Health joins medical research initiative

Utah-based Intermountain Health has been selected to join a nationwide initiative working to speed up implementation of potentially groundbreaking research in health care.

Intermountain is one of 42 health care organizations brought on board by the National Patient-Centered Outcomes Research Institute to contribute to the Health Systems Implementation Initiative.

Providing up to $500,000 for an initial project that helps to prepare health care organizations with future strategies, the Health Systems Implementation Initiative aims to accelerate the use of published research, cutting down what Intermountain said is an estimated 17-year lag between publishing medical research and its use in health care facilities.

Further funding for health care systems involved in the initiative will be provided if health care organizations support other projects promoting evidence from the National Patient-Centered Outcomes Research Institute.

With every implemented project, health care organizations can receive funds ranging from $500,000 to $5 million.

Dr. JP Valin, the chief clinical officer at Intermountain Health, said, “We believe that every patient … deserves to get the best care and the treatment and the most up-to-date and state of the art care that’s being delivered.”

He said the 17-year lag from the time medical research is conducted to when it’s implemented in a facility is because of the process to learn new practices.

Currently, to keep up to date on new treatment and care, Valin said, medical professionals read through journals and attend conferences, which can be a somewhat lengthy process. Then, the research can begin to seep into medical training to benefit patients.

Intermountain has been putting forward an effort to share information faster. Intermountain, Valin said, “has done that through the work of its Healthcare Delivery Institute, which we’ve had for decades now, as well as our clinical programs work.”

Intermountain’s ability to quickly share information has been nationally recognized, and the contribution to the Health Systems Implementation Initiative will only further encourage the sharing of health care research, Valin said.

The Health Systems Implementation Initiative aims to create a platform where researchers from around the country can share their findings, deploying best-care practices in a facility where health care professionals can gather and share more information to improve patients’ health, said Valin.

Valin said, “Then we can publish that (information) and share that more broadly around the country.”

Participants in the Health Systems Implementation Initiative represent 800 hospitals nationwide, serving nearly a quarter of the U.S. population.

Including academic medical centers, community-based systems, integrated health care delivery and finance systems, safety net health systems, faith-based systems, public health care delivery systems, and a medical center within the Veterans Health Administration, the Health Systems Implementation Initiative is taking “groundbreaking” steps, said Nakela Cook, executive director of the National Patient-Centered Outcomes Research Institute.

Cook said these steps will “lay the groundwork for future expansion and broader implementation by demonstrating pathways to uptake and sharing lessons learned across health systems.”

This sharing and implementation of medical research has “never been done on this scale before across the country,” Valin said.

Valin hopes to continue implementing life-changing research to benefit patients nationwide.