This month, UBC sponsored and presented at the Summit for Clinical Operations Executives (SCOPE) in Orlando, Florida. UBC’s presentations were focused on the utility of enriching real-world data (RWD) across both clinical trials and observational research. This fit into a larger theme that emerged at SCOPE – the hybridization of research facilitates better evidence generation and revolves around patient-centric study design and execution.
A prominent part of this over the last couple of years has been a focus on diversity in clinical trials, leading to recent diversity guidelines from the FDA and initiatives to increase diversity from the NIH. This generates a more complete picture of a product’s safety and effectiveness but also leads to improved health outcomes for minority populations who are now part of the drug development process.
This initiative for diversity is moving hand-in-hand with decentralization techniques aimed at engaging patients from diverse backgrounds more effectively. A key failure in achieving diversity in the past was not knowing how to best engage with patients that wouldn’t fit the profile for a traditional site-only study. Patients have now shifted their expectations on how and when they will engage with healthcare professionals. They are used to video calls, portals, and mobile messaging. This adds complexity to the development of protocols and study conduct but greatly benefits the ability to recruit patients (particularly in rare disease), reduce patient drop-out, and generate more comprehensive evidence for a product.
Pragmatic trials are another key component of this. Pragmatic trials are designed to evaluate treatments in real-world settings. Pragmatic trials often involve larger and more diverse patient populations than traditional randomized controlled trials (RCTs) and are designed to assess how treatments perform in the context of routine clinical practice. Pragmatic trials can also evaluate the cost-effectiveness of treatments and provide insights into how treatments can be integrated into existing healthcare systems. This enables them to be used to evaluate the safety and efficacy of treatments in populations that are often excluded or under-represented from traditional RCTs, such as pregnant women, racial or ethnic minorities, and the elderly.
The innovation that has exploded in both clinical trials and observational studies in recent years anchors back to this patient-centric approach. UBC is committed to our Patients First mentality in the design and execution of our research programs. Through initiatives like patient-mediated electronic medical record release and a distinct team dedicated to optimal patient recruitment and engagement practices, UBC fosters smarter, evidence-based decisions for better patient access, outcomes, and evidence generation. To get in touch, click here.
About the Author
Lee Randall is a Senior Project Manager in Peri- & Post-Approval Services at UBC. He has over 22 years of experience in the pharmaceutical industry, both academic and public. His experience includes Phase I, II, III, and Non-Interventional with therapeutic indications including, but not limited to, Hematology, Oncology (solid tumor, hematological malignancies, genomic profiling), Infectious Disease, and Rheumatology.