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)
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Full Phase IIIb BATURA Trial Results Show Airsupra Cuts Severe Exacerbations by 47% in Mild Asthma
May 20th 2025Results from the pivotal BATURA trial show that Airsupra (albuterol/budesonide) significantly outperformed albuterol monotherapy in reducing severe asthma exacerbations and systemic corticosteroid exposure, reinforcing its role as a next-generation, anti-inflammatory rescue therapy for mild asthma patients.
