Global ICON survey shows need for more efficient obesity clinical trial design to realise full potential of next-gen multi-indication therapies
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.
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.
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
For further information on this whitepaper, please visit www.iconplc.com/obesity.
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