Global ICON survey shows need for more efficient obesity clinical trial design to realise full potential of next-gen multi-indication therapies
ICON plc, (NASDAQ:ICLR) a world-leading clinical research organisation powered by healthcare intelligence, today released the findings of a survey of 155 biotech and pharma professionals from across the US and Europe focusing on multi-indication cardiometabolic R&D for therapies targeting obesity and its comorbidities.
Multi-indication studies are clinical trials that test how a treatment works for more than one condition or disease. As researchers uncover the potential of particular drug classes across interconnected diseases, the commercial opportunities have increased the appetite for additional research that targets multiple indications.
The findings indicate that most sponsors (83% of respondents) are pursuing multi-indication approaches in their obesity-related research. However, the survey results also suggest that sponsors may underestimate the complexity of these strategies - particularly when selecting inclusion criteria and endpoints - which can lead to inefficiencies in the clinical development process.
For example, nine in ten respondents reported that they are not implementing non-traditional study arms, such as master protocols. However, these designs offer pipeline efficiencies to multi-indication development by allowing enrolment of patients with different conditions into the same trial permitting different efficacy signals to be assessed.
Simon Bruce, MD, VP, Drug Development Solutions, Internal Medicine at ICON, commented: "In the last few years, obesity-related drugs such as GLP-1s have surged in popularity, as has interest in their applicability for other health conditions and related commercial prospects. This survey has shown us that respondents realise that trial design is of paramount importance in devising a multi-indication approach, but don't necessarily know the best way to go about it."
Sponsors surveyed are also likely to be neglecting to collect valuable longitudinal data and real-world evidence (RWE) that can help them make informed decisions about multi-indication clinical development. Only 14% reported pursuing multiple indications for a single drug based on longitudinal data, and only 19% reported following patients for more than three years.
Rose Kidd, President, Global Operations Delivery at ICON, noted: "The considerable logistical and statistical expertise needed to collect longitudinal data and generate RWE may help explain why sponsors report lower rates of adopting such tactics. We have experience working with sponsors on deploying tokenisation and real-world data tools to enable post-market follow-up, an important part of efficient multiple indication development."
Respondents broadly agreed that multi-indication R&D has the potential to accelerate innovation and drive benefits for patients and healthcare systems by increasing choice in a high-cost market with few approved options so far and burgeoning demand, with 77% believing that it would lower healthcare costs. ICON's latest whitepaper, ‘Obesity and beyond: Embracing multi-indication potential during clinical development', shares guidance on making the most out of multi-indication development and launch strategies so that such benefits may be realised.
Alongside the whitepaper, ICON has launched their new Centre for Obesity that delivers expertise and market intelligence with a ready-to-deploy infrastructure of 100 sites and an in-development database of 10,000 pre-screened patients across the breadth of comorbidities related to obesity. The range of patients, along with ICON's experience in imaging, cardiac safety, real world evidence, outcomes data, and tokenisation will enable sponsors to rapidly launch multi-indication research.
For further information on this whitepaper, please visit www.iconplc.com/obesity.
About ICON plc
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,900 employees in 106 locations in 55 countries as of December 31, 2024. For further information about ICON, visit: www.iconplc.com.
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