Master Protocol Trials

At Precision, we stay at the forefront of the latest advances in clinical trial design and have the statistical rigor and biomarker expertise needed to help you design a master protocol trial – expertise proven through successful implementation in the clinic. Whether you only need design support or full implementation of a master protocol trial, the Precision team is ready to help.

Master Protocol Trials

At Precision, we stay at the forefront of the latest advances in clinical trial design and have the statistical rigor and biomarker expertise needed to help you design a master protocol trial – expertise proven through successful implementation in the clinic. Whether you only need design support or full implementation of a master protocol trial, the Precision team is ready to help.

Master protocol trial design with Precision

Put our advanced clinical trial design experience to work for you

Trial design excellence

 

Basket, umbrella, and adaptive trial designs can be quite complicated. Combining them into a master protocol trial to gain even more efficient insight only adds to the complexity. Precision’s clinical trial design team is highly experienced in all aspects of advanced and biomarker-driven clinical trial design and implementation:

  • Basket trials
  • Umbrella trials
  • Biomarker-driven 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.

“Our focus is a personalized approach to the treatment of cancer.”

Pat Devitt Risse, PharmD
President, Clinical Solutions

“Our focus is a personalized approach to the treatment of cancer.”

Pat Devitt Risse, PharmD
President, Clinical Solutions

Tell us about your project requirements

Our expert team is ready to support your clinical design needs, ensuring maximum insight and efficiency from biomarkers. Start the conversation today.

Tell us about your project requirements

Our expert team is ready to support your clinical design needs, ensuring maximum insight and efficiency from biomarkers. 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 our other areas of expertise