Adaptive Trial Designs Gaining Momentum
Applied Clinical Trials
Faster go/no-go decisions is the primary driver of adaptive-design adoption by sponsors.
In ISR's 2015 Adaptive Trials: Market Dynamics and Service Provider Benchmarking report, a key takeaway reached is that the primary driver of adoption of adaptive designs is the ability to reach critical decision points earlier. This does not necessarily mean that trial timelines are shorter or costs are lower, but instead that the probable outcomes of these trials are determined earlier so resources can be more effectively allocated to more promising or profitable drugs or devices. ISR found this as a chief motivator for the continued growth of adaptive trial designs. While only 49% of respondents report that they are currently conducting a trial with an adaptive design, 82% anticipate they will be over the next 12 months.
Faster Go/No-Go Decisions the Top Driver
When ISR asked respondents what their main reasons were for conducting trials with adaptive designs, 63% said to make earlier go/no-go decisions.
The primary hesitation associated with using adaptive trial designs relates to the regulatory environment surrounding adaptive trials. Upwards of 60% of ISR's survey respondents perceived adaptive trials as at least "somewhat risky."
- Industry Standard Research (ISR)
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
