With over 3,300 attendees across 850 companies, the 16th annual Summit for Clinical Operations Executives (SCOPE) was a huge success.

As previous years have shown, what’s big at SCOPE tends to be big for our industry. Thus, we’re summarizing some key takeaways from this year’s conference to understand where the industry may be headed next.

Michelle Longmire, CEO, Speaks at the SCOPE panel: "Intersection of Innovative Development Models and Investment Approaches That Move the Needle At the Portfolio Level."

AI continues to prove its worth in clinical research

Pharma experts at the Summit for Clinical Ops Executives (SCOPE) 2024 discussed the role of artificial intelligence (AI) in clinical trials, acknowledging its potential benefits while still urging caution in its overall use.

AI is increasingly employed across various stages of clinical trials, including drug development, recruitment, protocol creation, trial setup, and data processing. However, concerns persist regarding the appropriate integration of AI alongside human intelligence and the need for robust governance frameworks. 

Brian Martin from AbbVie emphasized the importance of addressing questions related to security, privacy, ethics, and compliance. Hoifung Poon of Microsoft Health Futures highlighted the potential for AI to complement human capabilities but cautioned against overreliance, advocating for a collaborative approach to enhance effectiveness. 

Samar Noor from Bristol Myers Squibb noted the advantages of AI in data processing for reducing human bias but raised concerns about inherent biases in data sources and the need for greater diversity in datasets. 

In an interview with Applied Clinical Trials, Wendy Morahan, Project Manager leader expressed optimism about the future potential of conversational AI and generative AI in trial conduct. Wendy envisions scenarios where researchers have dynamic conversations with their data, asking questions in natural language and receiving immediate, relevant responses, which she believes will become an expected feature in future technology tools for clinical trials.

DHTs and digital measures are quickly becoming “best practice,” as companies look to assemble the big picture

With every other booth at SCOPE 2024 touting digital endpoints, devices, sensors, and/or wearables, it seems the digital health era is finally here. 

uMotif and MoCA Cognition are collaborating to integrate cognitive function testing into electronic data capture for CNS research, offering efficient pre-screening tools for identifying cognitive impairment.

ObvioHealth and Oracle Life Sciences expanded their partnership to enable efficient capture and analysis of clinical trial data globally, leveraging ObvioGo 2.0 for digital trial management.

Saama expanded its partnership with Pfizer to accelerate clinical research processes, utilizing advanced biometrics research and analysis solutions to streamline data review and regulatory submissions.

These partnerships and collaborations come fresh off the back of recently finalized FDA guidance around the use of DHTs in clinical research. 

DCT’s DNA continues to become standard in modern clinical trials

Pfizer shows how their trials are evolving.
Pfizer shows off how theirDCT modalities are evolving.

Several top pharma presented the ways that their trials are continually evolving. One prevalent theme among them is that aspects of trials that were once considered “decentralized” are becoming more standard.

This comes off the heels of recent FDA and EMA Guidance embracing DCTs and as technologies like eConsent, eCOA, and DHTs and as analysts predict double-digit CAGRs for these technologies.

You can read more about this evolution here, or sign up for our March 8th webinar on the same topic titled: Last Year’s DCT Is Today’s Clinical Trial.

Medable and Duke University showcase how eConsent is preferred by patients with their latest research

Medable announced its collaboration with Duke University on a research project examining the acceptability of enhanced electronic informed consent (eIC) in clinical trials, demonstrating positive feedback from participants regarding the informative and engaging nature of enhanced eIC.

The study looked at 24 patients who reviewed an eIC in a mock study for an investigative medicine to treat hypertension: half reviewed the text-only eIC first followed by the enhanced eIC, and the other half did the opposite. 

The study population was diverse in gender, age, race, and geographic location. Nearly three-fourths (71%) of the study participants said the enhanced eIC was more informative and indicated that the digital elements were personable and made them feel more informed, engaged, comfortable, and prepared to participate in clinical research.

“[The enhanced eIC] is more appealing to me as a human being, not just a study subject,” said a 63-year-old male participant. “It made me feel more comfortable and showed that people were really thinking about what needed to be done to make this more understandable to a layperson. Taking the time to put those extra digital explainers in the consent form gave me a personal feeling attached, whereas the other format was dry and cold…just a piece of paper.”

As decentralized approaches and technology become more common in clinical trials, the use of eIC may soon surpass the use of paper consent forms. 

In a large, bi-annual survey on patient experiences with clinical research, use of electronic consent forms (on an iPad, tablet, or other device) increased from 24% in 2019 to 44% in 2021, dipping slightly in 2023 to 32%.