SCOPE 2024: Key takeaways from a first-time attendee

By Darcy Grabenstein

Because this year’s SCOPE was my first rodeo, so to speak, it was rather overwhelming. Wanting to absorb as much as possible, I gorged myself, jumping from one session to the next. The programs covered it all, from Patient-centric Trial Design & DEI to Feasibility & Study Start-up to Patient Engagement & Recruitment to Data, DCTs, Real-World Evidence and much more. So many sessions, so little time.

Following are several morsels I’d like to share from the SCOPE smorgasbord:

Quality data (in clinical trials, AI & RWD)

Throughout the summit, I kept hearing two words over and over again. And, no, they weren’t “Florida sunshine.” The phrase “quality data” was mentioned so often that it morphed into a SCOPE mantra for me.

Starting with the Sunday afternoon kickoff plenary session, prior to the evening’s Super Bowl kickoff, Christoph Koenen of Bayer spoke about the importance of the quality of data and its role in innovation.

In Monday morning’s plenary session (introduced by Citeline Chief Revenue Officer Chris Crucitti, by the way), Robert Goodwin of Pfizer emphasized the quality aspect of clinical trials. “Quality is the most important element in clinical development,” he said, listing speed and cost as runners-up.

This session was followed by a panel discussion on generative AI, where AbbVie’s Brian Martin explained how AI can help sponsors with basic functions so they can focus more on strategy. “At the core of this is the data,” he said. Using the garbage-in-garbage-out rationale, he said AI models are only as good as the data fed into them.

I also attended a session on “Digital Innovations for Patient-Centered Clinical Trials Using Real-World Data (RWD).” Denis McMillan of Parexel hit the nail on the head when he said the pharmaceutical industry is suffering from “pandemic hangovers.” He acknowledged that using RWD in research “wasn’t that easy before the FDA mandate.” Parexel’s Camilla Ramdeen added: “The FDA really does need to hold people accountable.”

She referred to data points as “shiny pennies.” But panelists warned not to be distracted by the “shiny” element, warning that data points mean nothing in isolation; they must be aggregated to be of value.

Rethinking diversity in clinical trials

In the above-mentioned session, Parexel’s Karina D’Angelo stressed that we must look beyond race and ethnicity data. This theme was echoed in the Clinical Operations for Small Biopharma track. Tina Karunaratne, founder and CEO of Karuna Integrated Clinical Services, said diversity must also include rare disease patients. “When we talk about DEI (diversity, equity, and inclusion),” she said, “it’s important to think of equality and equity as synonymous.”

Another session in this track focused on clinical trial diversity plans, referring to the US Food and Drug Administration (FDA) guidance on race and ethnicity. However, as a member of the Diversity, Equity, Inclusion, and Belonging (DEIB) Committee at Norstella (Citeline’s parent company), I am particularly attuned to and interested in all underrepresented groups in clinical trials.

That’s why I also attended sessions dedicated to inclusivity of and overcoming barriers to LGBTQIA+ participation in clinical trials (more on this below). Garo Kiledjian, founder and CEO of the SGM Alliance ― which advocates for the inclusive and meaningful participation of sexual and gender minorities (SGM) in clinical research, healthcare, and the evolving life sciences landscape ― moderated the first session. He said study sponsors are not collecting sexual orientation and gender (SOG) data. “We’re not capturing the full picture.” Reinforcing the importance of LGBTQIA+ participation in research was the fact that SGM Alliance received an honorable mention in SCOPE’s Participant Engagement Award (see the winner below).

Just as lack of trust can discourage clinical trial participation by people of color, it also is a barrier for the LGBTQIA+ community. Sponsors can overcome this by using gender-neutral language in protocols, inclusion/exclusion criteria, informed consent documents, and recruitment and retention materials.

(Watch for my deeper dive into this topic and for additional takeaways on clinical trial diversity from Sheila Omondi, Senior Manager of Clinical Insights at Citeline.)

Patient-centricity

The Oliver Patch Project won SCOPE’s Participant Engagement Award, evidence that a winning concept does not have to be high-tech to be effective.

Brian Burkhardt, executive director and cofounder of the project, told attendees the story of his son Oliver’s cancer diagnosis. When friends and family asked what they could do to help, Oliver’s parents asked them to send patches with positive messages. Soon, they had collected 2,000 patches. They wanted to share the love with other pediatric cancer patients, and the Oliver Patch Project was born.

Other sessions focused on incorporating the patient voice in all stages of clinical trials, including protocol development. One example is Bristol Myers Squibb’s Patient Expert Engagement Resource (PEER), which was designed to do just that.

Burkhardt proudly wears his ‘patchwork’ jacket

Personal connections

SCOPE is about making connections. I reconnected with old acquaintances and met dozens of people, all with the shared passion of getting the right treatment to the right patient at the right time. It’s also about personal stories. As one panelist noted, “We’re all touched by disease.”

What was most powerful for me ― and for many attendees ― was hearing panelists’ personal experiences of how clinical research touched their lives. While Citeline is recognized industry wide for our quality data, it was our presentation on Investing in Patient Engagement & Recruitment as a Strategic Initiative that received the most positive feedback during SCOPE. Why? Because panelists shared their personal stories.

Chmura, Washington-Moore and Holms

Krystyna Chmura, Clinical Trial Solutions Senior Advisor/Life Sciences Data at Evernorth, participated in a clinical trial when she was a child. She shared how this led to her career in the life sciences. Jessica Washington-Moore, Senior Director of Implementation at Citeline, told of the impact her mother’s diagnosis of HER-2 positive breast cancer had on her. And Matt Holms, Vice President,Sales-Patient Engagement and Recruitment at Citeline, said his son Matthew was diagnosed with autism spectrum disorder (ASD) in 2019; his condition was compounded by the COVID pandemic. He said enrolling his son in a clinical trial made a “huge difference” in his family’s life.

In the session “Inclusivity for the LGBTQIA+ Community: Count Me In,” Evan Ko of AbbVie was open about the challenges they face as a transgender individual. Ko said that when healthcare professionals make all patients feel welcome it enables them to let their guard down and feel safe.

Overall, SCOPE was very satiating, from the topics to the people to the setting. It may be a full year, however, until I’m ready for seconds.