The Scoop on the SCOPE Summit

SCOPE Summit 2025 is a wrap, and we take a look at a few key takeaways from this information-filled conference.

By Darcy Grabenstein

SCOPE 2025 was a four-day blur of showing up, showing how and, yes, a bit of showing off. For those of us from colder climates, Orlando was a welcome respite from bone-chilling temperatures.

At SCOPE, however, there was no letting up when it came to sharing and learning. Topics ranged from industry partnerships to patient recruitment and retention, with an emphasis on the latter. Dan Brenner, CEO & Founder of 1nHealth, caught my attention when he said, “Don’t do recruitment.” He continued: “Recruitment is an activity. Own enrollment.”

Following are a few themes that resonated throughout the conference.

Clinical planning (no surprise here)

Of course, at a conference for clinical operations professionals you’d expect clinical planning to be a constant in the agenda. One way to transform clinical trials is by starting with intelligent design, according to a session led by Akiko Shimamura, Senior Vice President, Trial Design & Optimization, at TriNetX.

Citeline’s Morgan Sellars with Chiesi’s Hélène Raptis

Although it fell on the last day of the conference, when many attendees had already gone home, the Citeline-Chiesi session “How to Overcome Trial Planning & Recruitment Challenges” attracted a respectable crowd. Morgan Sellars, EMEA Sales Director for Patient Engagement & Recruitment at Citeline, and Hélène Raptis, Head of Feasibility Intelligence at Chiesi Farmaceutici, discussed how Chiesi revisited its internal structures and processes in order to fill a gap in the digital footprint for its clinical research. Key considerations were:

• Selecting the right partner
• Securing management buy-in
• Managing aggressive timelines
• Scaling cross-domain collaborations

“What was important,” Raptis said, was making management “understand the shift in the mindset of patient approach towards clinical trials and … that we could not afford as sponsors to ignore that evolution, that shift in patient's mindset.”

Raptis also shared the importance of not working in silos, of bringing together various departments such as compliance, transparency, legal medical affairs. “They were not consultants; they were owner of their own domain. ... And that was very important to have that one message.” She added that having everyone in the same room avoided duplication of work.

Data (RWE, RWD, and proprietary)

The topic of data was front and center from the get-go. “Our currency is clean, critical data,” stated keynote speaker Andrew Lee Senior Vice President & Head, Global Clinical Trial Operations, of Merck & Co.

In a session on rethinking recruitment through site, sponsor, and vendor alignment, Will Furness, CEO of the Centricity Research site network, predicted that interoperability will be the key to future trial success. He added that sharing of data will play an important role. Kelly McKee, Head of Innovative Patient Recruitment at Evinova, AstraZeneca’s health tech company, adding, “It’s really important that we use the data for good.”

Diversity in clinical trials (or lack thereof)

AbbVie held a session focused on site selection strategies for diverse enrollment success. Erin Reynolds, Associate Director of Data Science & Analytics, said real-world data (RWD) can be used in different ways to promote clinical trial diversity. For example, it can be used to see the disease population and also identify where the patients are geographically.

I loved the title of this panel discussion: “Diversity in Clinical Trials: The Homework & the Homeruns.” Kate Wilson, Director of Global Clinical Operations for Biogen, said her company is not waiting for FDA updates. Wilson sees the Diversity Action Plan (DAP) guidance as a template, one that informs budget, timelines, and patient recruitment. She added that it prompts sponsors to be strategic in site selection, including looking at epidemiology data.

Although the Food and Drug Administration (FDA) recently removed its diversity guidance from its website, in another diversity-focused session Casey Orvin, CCO of Alcanza Clinical Research, said, “We need to continue doing the right thing … whether we’re mandated or not.” He emphasized the importance of patient education and bringing patients into the conversation.

Brittany Gerald-Lewis, Associate Director of Clinical Trial Health Equity at Moderna, added, “We have to increase our pool of investigators and sites.”

Panelist Adrelia Allen, Executive Director of Clinical Trial Patient Diversity at Merck, said sponsors need to be more strategic in their site selection. “It (DAP) challenges us to be more creative working with our sites.”

One of several diversity resources cited at SCOPE was the Multi-Regional Clinical Trials (MRCT) Center’s diversity in clinical research toolkit, described as a playbook for the industry. (See this and other related resources in Citeline’s diversity hub.)

Melissa Harris, Fortrea, and Vince Spurr, Citeline

Citeline was well represented in diversity-related sessions. Vince Spurr, Senior Manager Sof Solution Consulting, and Melissa Harris, Global Head of Patient Recruitment & Engagement at Fortrea, discussed how patient-first feasibility frameworks can move the needle on diversity. Harris warned that there’s more to trial diversity than meets the eye. “Sometimes it just becomes a tick box because that’s what the regulators say they need.”

Citeline's Fenwick Eckhardt

Spurr said Citeline’s performance data, diversity data, lab data, EMR data, claims data — all these different individual data sources — help bring sponsors closer to the patient.

Any discussion on trial diversity inevitably circles back to removing barriers. That was the focus of one session led by Jim Murphy, Greenphire CEO, and Adrelia Allen, Director of Clinical Trial Patient Diversity at Merck. A recurring sentiment in this and other sessions was that the sponsor-patient relationship should not be just transactional but a partnership. That is, communication should be maintained before, during, and after a trial.

Citeline’s Fenwick Eckhardt, Senior Manager of Clinical New Product Development Strategy, joined a panel discussion on the challenges of diversity data in clinical trials. “It’s not just about enrollment but retention” of patients, she said. “You want to be able to hold their hand through the trial.”

Artificial intelligence (AI)

“I think AI has an absolutely essential part to play in structuring unstructured data,” said Fortrea’s Harris. “We have way too many disparate datasets.”

One of the many impressive keynote presentations focused on generative AI. The crowd was polled to gauge sentiment on AI’s impact. I found that my answers matched those of the majority for all three questions. While Citeline is leveraging AI to streamline clinical planning, the pharma industry as a whole has a lot of catching up to do. And, based on our AI-enabled solutions, I know that this technology frees up study teams from labor-intensive tasks so they can focus on the research. It also greatly reduces timelines, such as generating a list of protocol-specific investigators in minutes, compared to the traditional process that can take four to six weeks.

Regulatory

Although meeting regulatory requirements is a critical part of the drug development process, the sessions I attended focused on other areas. One session, “Challenges of Including the Patient Voice in EUCTR submissions,” put more emphasis on patients and partnerships than the clinical trial disclosure process itself. “You have to have good partners,” said Tricia Buchheit, Director of Patient Recruitment, Alnylam Pharmaceuticals.

The topic of EU submissions was quite timely. According to the European Medicines Agency (EMA), all ongoing clinical trials in the EU had to be transitioned to the Clinical Trials Information System (CTIS) by the end of January. This marked the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the EU.

Because I live in the Greater Philly area, I would be remiss if I didn’t mention several references to the Eagles throughout the conference. The folks from appropriately named Greenphire made us Eagles fans proud with their football jerseys and color-coordinated booth. And now that the Eagles have clinched the Super Bowl, I will close my wrap-up with these parting words: Go Birds!