Unleashing the Power of Real-World Evidence in Drug Development

The New England Chapter was pleased to host Unleashing the Power of Real-World Data in Drug Development with Janel Titus, PhD in March. Real-world data is pivotal in the pharmaceutical industry, impacting safety, efficacy, and outcomes. It empowers companies to make informed decisions, optimizing operations for patient benefit. Real world data include clinical data from electronic health records, claims & utilization data, patient-generated data, and public health data from registries and genomics.

Real-world data offer numerous benefits, enabling a thorough comprehension of real-world patient behavior and outcomes. Notably, it includes high-risk groups and provides large sample sizes at a lower cost without strict eligibility criteria. However, challenges such as data quality, completeness, biases, and the absence of controlled environments persist. Addressing these hurdles requires a meticulous evaluation of real-world data’s suitability, involving purpose, data quality, relevance, and biases.

Real-world data produce invaluable real-world insights and evidence. Real-world insights from real-world data streamline drug development, improve clinical trials, speed time to market, and enhance post-market patient surveillance. Meanwhile, real-world evidence shapes trial designs, guides clinical guidelines, aids financial negotiations, informs reimbursement decisions, supports regulatory processes, and drives further product applications.

Despite its potential, integrating real-world data into pharmaceutical decision-making poses challenges. The journey from data vendors to analytics platforms to scientists requires overcoming limitations in insight capacity, reducing vendor reliance, breaking down siloed knowledge, fostering cross-team collaboration, addressing technology constraints, and streamlining dataset access.