While traditional randomized controlled trials (RCT) are the gold standard for generating high-quality, reliable clinical evidence, they are notoriously time-consuming and costly. By integrating real-world data (RWD) in trials, researchers are designing studies that are far more efficient without sacrificing scientific rigor. Read below to learn about several approaches that leverage RWD to reduce the cost, time, and required enrollment in RCTs to streamline clinical development.
External Control Arms
ECAs cut required enrollment in half by replacing the control arm with patient data derived from RWD. ECAs are particularly beneficial for conditions where it is difficult/infeasible to enroll a sufficient number of patients in an RCT. Discover how ECAs leverage real-world data to accelerate treatment development for rare and high-unmet need conditions.
Hybrid Controlled Trials
Hybrid controlled trials are RCTs that combine both traditional internal controls and external controls from RWD. This approach reduces the burden of enrolling a full control arm, decreasing both the time and financial resources required while ensuring the comparability of the external controls to patients directly enrolled in the trial. Learn more about how hybrid controlled trials balance efficiency and rigor by integrating real-world data with traditional RCT methods.
RWD Covariate Adjustment
By adjusting intervention effects to account for unbalanced prognostic covariates between the treatment and control arm, covariate adjustment using RWD can substantially increase statistical power and reduce required enrollment in both arms. Explore how advanced statistical models using real-world data enhance trial efficiency through prognostic covariate adjustment.
Registry Randomized Controlled Trials Registry randomized controlled trials (RRCT) facilitate faster patient recruitment by capitalizing on an established data collection infrastructure, embedding the randomization process within existing clinical registries to ensure that the evidence generated retains a high degree of external validity while also providing the methodological rigor required for causal inference. Find out how registry RCTs streamline patient recruitment and maintain high-quality evidence using existing clinical registries.
Pragmatic Trials
Pragmatic trials diminish the need for supplementary data collection and decrease operational costs by evaluating the effectiveness of interventions in settings that mirror routine clinical practice, rather than under tightly controlled conditions like many RCTs. Dive into how pragmatic trials reduce costs and improve real-world relevance by evaluating interventions in routine clinical settings
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