As Elisa Cascade, MBA, Chief Product Officer for Advarra, begins her volunteer duties as the 2024 Chair of the Association Board of Trustees (ABoT) for ACRP, she took time to answer some questions about her experience in the clinical research enterprise, some of the challenges facing it, and how ACRP can help to address them.
Q: Can you give us the quick highlights along your career roadmap to serving as the 2024 Chair of the ABoT that you believe will help you achieve your goals in this role?
A: Like many people I know, I didn’t go to college to become a clinical research professional. I started in healthcare consulting and, through a series of company acquisitions, I was able to continually seek out new opportunities which led me to experiences in health economics and outcomes research, Phase IIIb/IV studies, direct-to-patient research, innovative eClinical technology, and ultimately to connecting the site/sponsor technology ecosystem where I am today. I hope that my deep understanding of both site and sponsor pain points will continue to benefit ACRP as we look for ways to facilitate collaboration across the industry.
Q: What clinical research workforce and overall industry challenges are top of your mind for addressing this year? What can ACRP, as a volunteer-driven organization, do in 2024 to support its stakeholders—members and non-members alike—as they face up to these challenges?
A: In my opinion, perhaps the greatest challenge facing the industry today is workforce sustainability—a cause that ACRP has devoted much time and effort to through its Partners Advancing the Clinical Research Workforce™ and other initiatives. As is often the case with challenges, the issues threatening workforce sustainability are multi-factorial, but as an individual with expertise in eClinical technology, I am acutely aware that the friction between site- and sponsor-provided technology is burdensome to the site (and, according to Advarra’s 2023 Site survey, this burden has grown over the past five years). Given ACRP’s relationships with the clinical research workforce, study sponsors, and technology providers, we are uniquely positioned to educate and ultimately facilitate meaningful conversations that will form the basis of future actions to streamline the research process.
Q: As someone with in-depth knowledge of technology product vision and management for clinical research settings, can you offer any observations and/or predictions about where things stand on the pace and scale of technology uptake vs. where we would ideally be in order to realize a more efficient and effective enterprise?
A: Today, one of the most common themes I am hearing from research sponsors and contract research organizations (CROs) is “how can I continue to deliver the same number of studies with growing protocol complexity at a lower cost.” Technology is definitely one of the levers under consideration (automates process/decreases labor and improves compliance for what historically has been a manual process), but unlike during the pandemic where the checkbook was open for any technology that kept a trial running, for 2024 and the foreseeable future, there is a much greater emphasis on outcomes measurement for return on investment (ROI).
What is the impact for sites? Expect the number of sponsor-provided technology systems to stay high, but in return, sites, with ACRP’s support, need to continue to be vocal about the need for a more streamlined user experience, such as: simple, intuitive applications, single sign-on with the site’s own credentials, and connectivity with their preferred site technology.
Q: There is no wrong answer here—can you share your three best guesses about what the “next big thing” in clinical research will be?
A: Having been around this industry for a while, I’ve seen a lot of “the next big things” come and go, but what is interesting is that a more moderate footprint often remains. Take eConsent, for example. Use skyrocketed during the pandemic for remote signature, but the importance of educating participants about a study and providing them a copy of their signed consent is what has remained—regardless of whether the patient consents in the clinic or at home.
So, some thoughts on three “next big things” and “what remains” for 2024:
1. Decentralized Clinical Trials (DCTs): During the pandemic, the push was for a 100% decentralized model, but what remains? The need for established research sites to support a small proportion of study patients who want access to new treatment options, but who can’t travel to a clinical trial site for all or some of the required study visits. This includes oversight of research-naive local physicians, facilities, and/or ancillary personnel (such as visiting nurses) to conduct study activities. ACRP’s new DCT Budget Buddy™ tool was developed to help sites receive accurate and adequate reimbursement for managing these DCT-related study elements.
2. Patient-Driven Site Identification: Sponsors/CROs are spending large amounts of money to leverage health record and other data to locate qualified patients, especially for rare diseases or complex inclusion/exclusion criteria. So, what remains? Likely a combination of delivery models including, but not limited to: continued referral of patients to established sites, requests for established sites to oversee remote patients/providers (see DCT above), and just-in-time site start-up (i.e., once a patient has been identified). From the site perspective, this means being prepared to demonstrate patient availability and/or past performance and having a repeatable start-up process with known timelines (from document collection through institutional review board approval). Use of sponsor technology for participant qualification and enrollment is also likely to grow to streamline tracking of referrals from the site’s own database and multiple other sources. This is another area where sites, with ACRP’s assistance, should push for integration to lessen the site burden of participant status tracking.
3. Artificial Intelligence (AI): Today, it feels like AI is the answer to “everything, everywhere, all at once,” but what role will AI play in the coming years? AI will remain in places where it is cost-efficient to deploy. Advarra has seen labor savings in software coding and document generation, for example, but has yet to recognize sufficient ROI in other areas such as protocol data extraction (great concept, but in detailed evaluation, the AI cost was projected to outweigh the volume of work and associated effort). Recognizing that most non-academic sites will lack the information technology sophistication to develop AI in-house, they will likely be dependent on sponsors, CROs, and technology providers for operational efficiencies. Site personnel, however, will likely find benefit in leveraging OpenAI for “crowdsourcing” first drafts of documents such as job descriptions, training content, consent forms, and contracts (i.e., it’s a lot less effort to edit than to generate content from scratch).
Edited by Gary Cramer