Life science executives recently convened in Chatham, Massachusetts, for the 15th annual Clinical Operations Retreat for Executives (CORE East), a transformative event hosted by Halloran Consulting Group. What makes this event transformative? From the attendees’ perspectives, this event fosters off-the-record conversations and encourages a unique atmosphere of collaboration and openness among industry leaders so we can individually do our part to collectively improve the business and approach to clinical development.
The three-day event proved exceptional this year, with unprecedented levels of collaboration, authentic discussions, and a shared motivation to revolutionize our approach to clinical development. Each year centers around a theme, and this year focused on ‘clinical operations: spearheading disruptions to accelerate change.’ The panels and fireside chats moved beyond what is considered traditional clinical operations and highlighted a cross-functional, end-to-end clinical development process that challenges our standards and pushes for smarter, more efficient approaches. This is where we must continue to grow as an industry.
As you look to positively disrupt your clinical research processes in 2024 and beyond, we hope you can leverage these three key lessons from our CORE East 2023 program.
Trust is Key to Patient Centricity and Diversity – Never Lose Sight
Patient stories shared at CORE East underscored a universal truth – trust is the bedrock of healthcare. During the presentation, “Compassion and Empathy: Finding the Missing Link to Achieve Powerful Clinical Study Design,” the team at Clario shared a concerning statistic: “78% of people have limited or no trust in pharmaceutical companies.” Though we cannot change our past, we must let this stark reality sink in and lean into the call for a paradigm shift in our approach to clinical trials.
The objective is not just increased trial enrollment, but an entire healthcare paradigm that prioritizes the well-being and satisfaction of those it serves. To be better as an industry, we must prioritize patient needs over business metrics and ‘check the box’ processes, focusing on creating a trial experience founded on compassionate communication, transparency, and patient input. Elevating the patient and caregiver experience requires a commitment to education, empowering them with knowledge for informed decision-making, and connecting with them in ways that are centered and compassionate every step of the way.
Embrace Artificial Intelligence for Clinical Development Efficiency
Although our industry has embraced AI adoption in discovery and early clinical research, there’s hesitancy in applying AI models throughout the entire clinical development lifecycle. Though the integration of AI in clinical research is imperative for enhancing clinical development efficiency, there are sticky misconceptions that often prevent AI usage.
Demonstrations at CORE East showcased the transformative power of AI at various complexity levels from translating protocols into multiple languages within minutes to simplifying complex information for broader comprehension, exemplifying we can start small and still reap big benefits. For example, a clinical research summary can be drafted to a specific education level within minutes. While this AI-enabled outcome does not ‘do’ the job for a clinical researcher, it gives them a head start and saves significant time, especially if clinical summaries are a part of their daily routine.
You may be wondering, ‘where can I start at a beginner level?’ Think of what is consistently time-consuming, like drafting clinical summaries, and discover an AI tool to enable efficiency for that task. Just begin with one time-consuming task.
Embracing AI tools can dramatically decrease operational burdens, but it requires a departure from traditional approaches. It requires that we start somewhere, as seen in the example above, then evaluate the outcome and assess for additional task-based needs that will bring additional efficiency and positive outcomes. As you consider adopting new AI models, you and your team may face resistance from those in your organization and will need to navigate the pitfalls and misconceptions around data quality, data privacy, and job loss as moving through these barriers are crucial steps towards realizing the immense potential of AI in clinical research.
Streamline Clinical Trial Vendor Selection for Study Start Up Efficiency
The process of selecting and qualifying vendors for clinical trials is cumbersome and expensive. As shared during the event, research by Ken Getz and his team at the Tufts Center for the Study of Drug Development indicate vendor qualification takes an average of four and a half months for a single service provider.
Qualifying and selecting the right vendor and negotiating optimal terms of the engagement is critical to the timely completion of a high-quality study. During this long four-and-a-half-month process, clinical trial sponsors will need to meet with a pool of vendors who meet their criteria, provide uniform specifications to facilitate comparisons, assess capabilities, critically review budgets, examine expertise and experience, assess data solutions and technology infrastructure, and other factors including their reputation in a qualitative and quantitative manner.
Collaboration between sponsors and vendors as partners with open communication about needs and expectations is a key aspect of streamlining the process. Keep in mind that centralized approaches or risk-based models can focus efforts on what truly matters for a given study and may narrow your vendor options. While full standardization might be challenging due to the diversity of studies you’re managing, there are clear opportunities to optimize elements of the vendor qualification, selection, and management process, but this approach calls for an industry-wide shift and a willingness from stakeholders to collaborate toward shared goals of quality, efficiency, and ultimately, patient benefit.
In conclusion, CORE East 2023 facilitated valuable insights and ignited a collective commitment to reshape the future of clinical development. As industry leaders, it is our responsibility to do our part to heal the trust issues found in clinical research, move beyond standard operations, leverage AI to tap into enhanced efficiency, and streamline processes for the betterment of those we serve. The question now is, are you ready for the transformative journey ahead? The attendees at CORE East certainly are.
Halloran is available to learn about your pressing clinical research challenges and walk your journey with you. Contact us today.