Clinical Trial Design that Maximizes Biomarker – Driven Insights

Precise science leads to better targeting of patient populations. Flexibility in design is essential to responding to emerging biomarker data by adapting study conduct. Patient populations can be refined based on umbrella or basket designs, depending on the nature of the study drug and relevant indications. Our team of Precision experts focus on protocol nuances to match each patient with the optimal study population and gain valuable insights from biomarkers. This results in a “rapid-to-market” strategy precisely tailored to your product, population and required data.

Clinical Trial Design that Maximizes Biomarker – Driven Insights

Precise science leads to better targeting of patient populations. Flexibility in design is essential to responding to emerging biomarker data by adapting study conduct. Patient populations can be refined based on umbrella or basket designs, depending on the nature of the study drug and relevant indications. Our team of Precision experts focus on protocol nuances to match each patient with the optimal study population and gain valuable insights from biomarkers. This results in a “rapid-to-market” strategy precisely tailored to your product, population and required data.
Basket & Umbrella Trials

We carefully select sites for both their scientific expertise and patient recruitment success, then maintain constant communication for nimble decision-making that accelerates proof-of-concept.

Biomarker Clinical Trials

We use diagnostic, prognostic and predictive biomarkers to enable informed decision making, resulting in faster approvals and a statistically higher rate of commercialization.

Master Protocol Trials

We stay at the forefront of clinical trial design, pairing statistical rigor and biomarker expertise to design and implement master protocol trials.

Informed by biomarkers. Designed for insights.

Biomarkers have the power to accelerate every phase of clinical research – yet they can add complexity, requiring advanced clinical trial designs. Precision was purpose – built to maximize insight into human biology, integrating rigorous science with advanced statistical analysis.

This expertise informs every clinical trial design – basket, umbrella, master protocol, or adaptive design. With end-to-end services, we select the optimal approach for your study, swiftly develop the most advantageous trial design, then implement our plan to capitalize on the inherent efficiency of biomarker – driven studies.

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

Precision for Medicine, Oncology and Rare Disease has been working with a sponsor since 2013 on a trial with an adaptive approach to exploring multiple tumor types concurrently, as an accelerated pathway to proof-of-concept.

Targeted patient: The study targets subjects with a specific rare mutation. The protocol identifies a list of possible mutations. All patients are required to have genomic assays completed with the mutation identified prior to consideration for enrollment.

Study Design: The initial protocol had 8 different tumor-specific mutation cohorts in a Simon’s 2-stage design. For the first stage, 7 patients are enrolled; if 1 response is observed the cohort expands to stage 2. If no responses are identified, the cohort may be closed, with new tumor types identified. Tumor types are ruled “in” for further exploration (up to the point of accelerated approval or phase 3 investment) or “out” within this trial.

Discover how our clinical trial design experts can advance your international clinical trial

Discover how our clinical trial design experts can advance your international clinical trial

Related 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 Trial Management

Fully integrated biomarker-driven trial management solutions-from study start-up through full-service execution-help accelerate your path to approval.

Clinical Development Strategy

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

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