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Basket, Umbrella and Adaptive Designs for Clinical Trials

Statistical sophistication to design complex clinical programs, with Precision
Biomarker-driven clinical research can accelerate development timelines, but realizing the full extent of these efficiencies requires advanced trial designs. Precision is built from the ground up to conduct biomarker research, offering robust clinical and translational capabilities. 

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

  • Basket Trials
  • Umbrella Trials
  • Basket Trials: Deep Expertise in Design and Execution

    Our team's extensive experience informs our focus on direct application and efficiency, utilizing statistical rigor to manage complex data, streamline processes, and deliver clear results. These designs allows for swift adaptation to emerging data, ensuring that clinical research directly contributes to the development of targeted therapies.
    Biomarker-driven clinical trial strategy - Basket Clinical Trial - Precision for Medicine
  • Umbrella Trials: Specialized, Patient-Centric Strategies

    This strategic approach allows us to simultaneously assess various treatments, enhancing the precision of therapeutic matches for patient subgroups. Designs prioritize direct outcomes, data integrity, and operational efficiency, streamlining the route to tangible treatment advancements.
    Biomarker-driven clinical trial strategy - Umbrella Clinical Trial - Precision for Medicine

Biomarker data meets rigorous statistical approaches

Our experienced biostatistics team knows how to combine biomarker data with robust statistical approaches to design a clinical trial that maximizes both insight and efficiency. 
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Basket trials_Doctors discussing results
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 this case study.

Download case study

Advance therapeutic breakthroughs with Precision

Explore the breadth of our expertise in therapeutics and modalities as we lead your novel treatments in oncology, rare diseases and beyond, from the groundbreaking idea to clinical realization.

Insights from Precision’s experts

Stay ahead with the latest insights from Precision’s team of experts. Discover valuable perspectives, updates, and strategies in innovative clinical trial design and execution. 

Read: Rescuing a Complex Hematology Oncology Trial: Case Study in Precision Rescuing a Complex Hematology Oncology Trial: Case Study in Precision

Clinical Trials

Rescuing a Complex Hematology Oncology Trial: Case Study in Precision

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  • Anne K. avatar Andrea​ C. avatar Hasni M. avatar
  • Anne K.

    Andrea​ C.

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Read: Safety isn’t a Milestone but a Mindset in Clinical Research Safety isn’t a Milestone but a Mindset in Clinical Research

Clinical Trials

Safety isn’t a Milestone but a Mindset in Clinical Research

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    Renise Blythe

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Read: Case Study: Streamlining Radiopharmaceutical Clinical Trials Case Study: Streamlining Radiopharmaceutical Clinical Trials

Oncology

Case Study: Streamlining Radiopharmaceutical Clinical Trials

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    Tai Bibbs

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Leverage an integrated infrastructure that reduces the inefficiencies inherent in complex development. Integrate lab and trial execution to increase speed to market. Incorporate manufacturing expertise for advances therapies to ensure scalability. Precision can customize and converge our capabilities for your program's unique needs.

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