Protocol optimization, site selection, and patient identification driven by data and technology

Protocol Optimization and Patient Identification by Flatiron are an adaptive set of data and tech-enabled services designed to optimize clinical trial protocols, appropriately match the right trials to the right sites, and identify trial-eligible patients at the point of care.

PROTOCOL OPTIMIZATION BY FLATIRON

Trial success starts with a well-designed protocol

Access customized reports for each trial’s unique needs

From our oncology RWD containing >3.5M patient records, sponsors receive tailored insights around the epidemiology of disease at the indication level, comparisons of a trial-specific cohort vs. indication-level cohort, eligibility criteria sensitivity analysis, enrollment projections among US community oncology sites, and more.

Increase the eligible patient pool

By assessing the impact of changing various inclusion and exclusion criteria on potential enrollment numbers, we can expand the eligibility pool and make it more representative.

Reduce costly and time consuming amendments

Up to ~90% of trials have at least one substantial protocol amendment. Set your trials up for success from the start with RWD-driven optimization insights that increase the probability of operational performance.

PATIENT IDENTIFICATION BY FLATIRON

Accelerate your trial with data-driven site and patient identification

Open clinical trials at the most promising sites

Flatiron’s network of US community oncology sites have activated over 1,300 oncology trials in the past two years. We use high-quality, contemporaneous RWD to assess the potentially eligible patient population at research sites in this network to optimize your trials for enrollment success.

Enhance specificity in patient identification assessments

We employ structured clinical and genomic data (e.g., diagnosis, metastatic status, biomarker results) and unstructured data processed via machine learning to rapidly and accurately identify potentially eligible patients, while also reducing screening burden on sites.

Identify patients at the exact moment of treatment decision-making

We deliver alerts to physicians directly in the EHR, identifying potentially eligible patients at the precise point of eligibility. Our matches are also based on 24-hour data recency, meaning matches are made on the most up-to-date data.

BY THE NUMBERS

>45% increase in eligibility of Black patients

Phase III multiple myeloma trial: Flatiron identified two specific changes to the inclusion/exclusion criteria that increased eligibility of Black patients by 47% and 24%, respectively.

>25 sites identified

Triple-negative breast cancer trial: Flatiron identified 27 US community oncology sites with a high volume of racially and ethnically diverse, potentially eligible patients.

>10% of total trial enrollment

Phase II ultra-rare disease basket trial: Over 10% of total trial enrollment was driven by Flatiron services, including the first-patient-in on one of the rare, biomarker defined trial arms.

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Optimizing clinical trials: Getting the right results by keeping it real

In this report, learn why over 80% of biopharma and contract research organization leaders are incorporating RWD into their protocol optimization and site selection processes.

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