Clinical Trials

June 2023 | www.futureofpersonalhealth.com

“We want patients to feel empowered to talk with their providers about clinical trials.”

Ramita Tandon, Chief Clinical Trials Officer, Walgreens

Page 02

Dr. Hadiyah-Nicole Green’s Unique Perspective on Cancer Research

We talked to Dr. Hadiyah-Nicole Green, founder of the Ora Lee Smith Cancer Research Foundation, about her inspiration for using laser-activated nanoparticles as a potential cancer treatment.

What is special about your research and what does it mean for the future of cancer treatment?

My research is very different because I entered the field of cancer research as an outsider, without the traditional academic training of the people who normally design drugs or study cancer. I have an academic background and research experience in physics, lasers, nanotechnology, optics, high-speed internet, and satellites, rather than cancer biology. I also have the experience of being the primary caregiver for both of my parents who lost their lives to cancer — one suffered from cancer after refusing treatment, and the other from the treatment side effects.

When I had the idea that a local treatment will reduce the suffering of cancer patients, all of my experiences as a physicist and caregiver inspired the features of the cancer treatment I developed. No one should have to say, “I would rather die than experience the side effects of cancer treatments.” In this day and age where we have mega computers in our pockets and purses, we should have a cancer treatment without life-altering side effects. Why not?

I developed a local, site-specific, multicancer platform therapy, designed to treat a variety of solid tumors (e.g., breast, prostate, head and neck cancers), using lasers and nanotechnology that are harmless without each other. Our cancer treatment has completely eliminated human tumors (in mice)

in just 15 days after a one-time, 10-minute treatment without observed side effects, surgery, chemotherapy, or radiation.

What do you hope your cancer treatment helps to accomplish?

Because cancer charities raise over $1 billion per year, I reimagined this industry and started my own tech-based version to move beyond hope and help accomplish my goals for the cancer treatment I developed the Ora Lee Smith Cancer Research Foundation, a 501(c)(3) nonprofit organization, is on a mission to change the way cancer is treated and reduce cancer patient suffering by providing a treatment that is accessible, affordable, and effective.

Raising money through my nonprofit allows me to ensure this technology will be affordable and accessible for all, locally and globally. No one should have to worry about how they are going to afford the care they need to be well.

With more support, I hope my cancer treatment will shift the paradigm for how cancer is treated, how cancer patients are treated, and what is expected from cancer charities. I can’t reduce all human suffering, but this is one that’s within our reach with more funding.

The Society for Clinical Research Sites (SCRS) was founded in response to the growing need for an organization to advocate for the needs of clinical research sites globally.

With more than 9,500 research sites and 60 Global Impact Partners, SCRS facilitates a collaborative community dedicated to advocacy, education, mentorship and connection.

SCRS also offers hundreds of resources for clinical research sites and industry professionals such as webinars, Good Clinical Practice (GCP) training, diversity planning, white papers, site toolkits and much more. Connect with leading industry professionals at six annual SCRS summits hosted in the U.S., Europe and Australia, where sites, sponsors, CROs and industry service providers convene to share challenges, best practices, and establish valuable partnerships.

Be a part of a global community of dedicated clinical research, pharmaceutical and healthcare leaders with SCRS.

Demystifying Clinical Trials and Empowering Patients

People across the country struggle to learn about and participate in clinical trials. Local pharmacies may be the solution.

Clinical trials represent hope for people who have exhausted the standard options of care for a variety of disorders. But traditional barriers to participation in trials have inhibited the potential benefits — for example, 75% of clinical trial participants are white according to the U.S. Food and Drug Administration (FDA), but nearly 20% of the new drugs recently introduced affect various ethnic groups differently.

One major problem is recruitment as most trials don’t meet their enrollment goals. “Less than 5% of the U.S. population currently participates in clinical trials,” noted Ramita Tandon, chief clinical trials officer at Walgreens. “Historically, the clinical trial ecosystem has struggled to bring trials into communities.”

Going local Enrollment difficulties for clinical trials translate to slower research, fewer treatments, and less effective medications.

“One issue is the lack of information and education,” Tandon said. “From a patient’s perspective, there are other barriers: travel, language, digital and health literacy, or some of the negative events that have occurred for certain patient populations. There’s a lot of misconceptions out there, a lot of fear.”

Some of these barriers can be eliminated by bringing clinical trials closer to communities. Walgreens, for example, has launched a clinical trials business leveraging its established pharmacy presence and nationwide footprint to redefine the patient experience in research.

“We have access to nearly 9,000 pharmacies and millions of patients— we are in the fabric of every community,” noted Tandon. “When a patient comes in and is flagged as eligible for a clinical trial in our systems, there’s a natural dialogue that takes place with our pharmacy teams.”

Additionally, by providing broader access to the latest research and medicine, and ensuring the data underlying the marketing and approvals of medicines are representative of the populations

they’re meant to treat, Walgreens aims to help improve health outcomes.

Easy, safe, and accessible

Today, Walgreens is leveraging its rich data and compliance framework to identify the right populations to engage with to increase access and diversity in the trials it supports.

“We have the ability to mine for patients who might be eligible for a number of trials,” Tandon said. “First, we look at the requirements provided by the pharmaceutical company, then use the technology we’ve put in place to identify patients and put together a holistic view of their treatment journey.

“Then we can do outreach, whether it’s through in-store interactions, digital channels or call centers, to see if patients are interested in participating. As always, patient choices remain the central focus of the Walgreens experience.”

If the patient wants to proceed, they can answer some pre-screening questions. Then, if accepted into the trial, they will be directed either to a designated provider or to a Walgreens location where the company has set up a clinical trial center. Throughout the process, the patient is supported by their local Walgreens team, and Tandon stresses that Walgreens follows all regulations and applicable laws in terms of data storage and patient privacy. “We provide full transparency up front when we educate patients so they’re fully aware what information is collected.”

Bringing clinical trials directly into local communities not only helps people discover experimental treatments when existing therapies are ineffective, but also benefits the healthcare system as a whole: It increases the number of study participants to diversify clinical trial populations, which then speeds up testing and developing effective therapies.

The main goal is making people healthier. “We want clinical trials to be viewed as a care option,” Tandon said. “Ultimately, we want patients to feel empowered to talk with their providers about clinical trials.”

Scan here to learn more:

Publisher Aaron Palmer Business Developer Joanna Tronina Managing Director Julia Colavecchia Production Manager Taylor Daniels Lead Editor Dustin Brennan Cover Photo Courtesy of the Ora Lee Smith Cancer Research Foundation All photos are credited to Getty Images unless otherwise specified. This section was created by Mediaplanet and did not involve USA Today.

INTERVIEW WITH Ramita Tandon Chief Clinical Trials Officer, Walgreens

WRITTEN BY Jeff Somers

Why Increasing Women’s Participation in HeartHealth Trials Is Imperative

and lactating women in clinical trials. Increasingly, women with existing heart conditions are becoming pregnant and, in other cases, pregnant women are developing heart conditions. We must have a deep understanding of how to treat those heart conditions during pregnancy — and we can only do that when pregnant women are included in the research.”

Aiming for the heart

Did you know that more than 60 million U.S. women — about 44% — are living with some form of heart disease? That stat, from the CDC, is certainly alarming, yet many women aren’t aware of this pervasiveness.

INTERVIEW WITH Celina Gorre CEO, WomenHeart

WRITTEN BY Omar Sommereyns

Part of this is due to a lack of comprehensive, allinclusive research on heart health. Unfortunately, clinical trials haven’t always embraced women, and current participation rates remain on the lower end.

“Research on heart disease must include women — particularly women of color and others from communities who experience a disproportionate rate of heart disease,” said Celina Gorre, CEO of WomenHeart — a national, patient-centered support and advocacy organization. “When we’re included in the research, we can learn how to recognize, diagnose, and treat various heart conditions in ways that are effective for women.”

Otherwise, she added, “women often experience missed and delayed diagnoses or less-than-optimal treatments — even today — because we were excluded from the research for too long.”

Pushing for more engagement

According to a recent study by Harvard Medical School researchers at Brigham and

Women’s Hospital, only 41.2% of 302,664 participants (across 1,433 clinical trials focused on cardiovascular, psychiatric, and cancer-related illnesses) were female. Additionally, the study found that while “49% of the cardiovascular-disease patient population is female, only 41.9% of trial participants were female.”

Back in 1977, a Food and Drug Administration (FDA) policy endorsed the notion that women of childbearing potential should be excluded from Phase I and early Phase II drug studies. It was thanks to a new law passed by Congress in 1993 that the National Institutes of Health started intentionally to include women of all ages in clinical research.

But more work needed to be done. Enter organizations like WomenHeart. As pointed out by Gorre, WomenHeart “has been engaged over the last two decades in helping to pass legislation that requires the FDA and NIH to increase women’s participation in clinical trials and medical research — and to report the outcomes.”

“One example of our work,” she added, “is [making the] case for including pregnant

Even if some women are initially hesitant — or fully skeptical — when it comes to joining heart-health trials for various reasons, those who do soon realize that the benefits are manifold. Just speak with any WomenHeart Champion, such as Amanda DeRosa, who participated in a Yale research study for people with long QT syndrome (LQTS).

“When I first started in the study, it was emotionally difficult — a daily reminder of my disease that puts me at risk for sudden cardiac arrest and [a signal of] my new limitations,” DeRosa said. “But over time, I became proud of my participation. As a mother to a child who also has this same disease, I knew the results of this research would help not only me, but other women and future generations [too].”

And WomenHeart’s mission is far from complete. The organization continues to set forth pro-participation policies while delineating how to best make those happen, such as encouraging researchers to prioritize inclusive participation from the beginning stages of trial design.

“It’s critical that you meet potential patients where they are and in ways that build trust and understanding,” Gorre said. “But if you get too far along in the trial-design process before you consider those factors, it may be too late to overcome barriers that typically lead to low participation by women.”

Amanda DeRosa speaks during a briefing by WomenHeart on Capitol Hill in 2019.