Basket, Umbrella, and Adaptive Designs for Clinical Trials

Biomarker-driven clinical research can accelerate development timelines, but realizing the full extent of these efficiencies requires using advanced approaches such as basket, umbrella, and adaptive designs for clinical trials. At Precision, we’re built to handle biomarkers from the ground up and not only have the statistical sophistication to design and run an advanced trial, we have successful experience doing so.

Basket, Umbrella, and Adaptive Designs for Clinical Trials

Biomarker-driven clinical research can accelerate development timelines, but realizing the full extent of these efficiencies requires using advanced approaches such as basket, umbrella, and adaptive designs for clinical trials. At Precision, we’re built to handle biomarkers from the ground up and not only have the statistical sophistication to design and run an advanced trial, we have successful experience doing so.

Clinical trial design with Precision

Accelerate biomarker-driven clinical research with adaptive designs for clinical trials

Precision designs for efficient insight

Our experienced biostatistics team knows how to combine biomarker data with rigorous statistical approaches to design a clinical trial that maximizes both insight and efficiency. We will:

  • Choose the right approach for your study, whether it’s a basket design, umbrella trial, or other advanced methodology and/or requires adaptive elements
  • Build a trial design and statistical analysis plan that efficiently address your questions while minimizing type I errors
  • Address clinical trial questions such as
    • Safety
    • Endpoints
    • Dose finding
    • Randomization
    • Patient selection
    • Histology-independent treatment response
    • Imaging

Proactive planning to optimize the use of biomarkers in oncology clinical trials

Case Study: A “basket” trial and an accelerated pathway to proof of concept

Precision for Medicine had been working with a sponsor on a trial with an adaptive approach to exploring multiple tumor types concurrently as an accelerated pathway to proof-of-concept. However, the study had to overcome multiple challenges including a limited patient population (2% to 8% of all solid tumors), a biomarker approach that was not “standard of care” for all of the targeted cancers, and a complex patient screening process. In addition, the site study staff had to be able to handle highly technical genomic data.

Precision was able to design and implement a clinical trial for this study that has resulted in a total of 20 tumor-specific cohorts pursued and 7 treatment approaches eliminated. The trial continues to add cohorts and tumor-specific explorations, both as single and combination treatment approaches, and what started as 100 patients across 6 sites is now being
conducted at ~50 sites globally with 250+ patients enrolled.

Find out how Precision overcame these study challenges in the Case Study below.

“Preselecting participants so that only those with certain molecular subtypes of cancer are included in a trial significantly improves the opportunity of achieving response rates in a greater number of patients, in a shorter time frame.”

Patricia Devitt Risse, PharmD
President, Clinical Solutions

“Preselecting participants so that only those with certain molecular subtypes of cancer are included in a trial significantly improves the opportunity of achieving response rates in a greater number of patients, in a shorter time frame.”

Patricia Devitt Risse, PharmD
President, Clinical Solutions

Tell us about your project requirements

Our expert team is ready to support your clinical design needs, choosing an approach that will maximize your study’s insight and efficiency. Start the conversation today.

Tell us about your project requirements

Our expert team is ready to support your clinical design needs, choosing an approach that will maximize your study’s insight and efficiency. Start the conversation today.

Clinical trial services

Global Clinical Trial Footprint

Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.

Clinical Development Strategy

Tailored strategies consider the scientific, regulatory, and commercial factors that shape each trial, mitigating risk and advancing the development pathway.

Clinical Trial Design

Advanced trial-design approaches—including basket, umbrella, and adaptive trials—deliver biomarker driven clinical research. Deep experience in these highly complex trial designs maximizes both insights and efficiency.

Biostatistics

Seasoned biostatisticians and statistical programmers deliver insight into every trial phase, from study design to regulatory submissions, all backed by meticulous documentation and data monitoring.

Clinical Sample Management

Sample inventories from a global network of labs supply real-time processing in 55 countries; consolidated data from central labs, screening labs, and specialty labs with clinical data create actionable reports.

Explore other areas of expertise