Lessons from Industry Roundtable: Regulatory Roadblocks Around Decentralized Trials

Dr. Peter Wahl, MLA, MS, ScD, VP and Global Head of Scientific Affairs at CorEvitas, part of the PPD™ clinical research business of Thermo Fisher Scientific, discusses the critical role of protocol-driven registries in generating regulatory grade RWE to serve multiple and evolving evidence needs across the drug development life cycle. He covers key considerations for selecting the right type of registry, explains why registry data is the gold standard in RWD, and how it contextualizes safety and effectiveness to fulfill FDA and EMA post-marketing requirements.

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A pharmaceutical company aimed to launch a Phase III clinical trial for a new oncology drug, focusing on efficient and effective patient recruitment across diverse regions. They evaluated patient populations by analyzing demographics, social determinants of health, and geography. Investigator profiling included practice details, affiliations, referral networks, and clinical trial experience. The final step involved selecting and extracting target lists for implementation.

This white paper presents findings from the PurpleLab Migraine Study, which leverages real-world data to analyze migraine prevalence, treatment variations, and provider insights. The study examines data from approximately 10 million Americans diagnosed with migraines, focusing on patient demographics, treatment pathways, and healthcare provider specialties. Key findings include the high prevalence of migraines among females aged 18-54, racial and ethnic disparities in treatment, and the significant role of specialized providers like psychiatrists and neurologists in managing migraine care. It highlights the importance of tailored treatment approaches and the potential benefits of complementary and alternative medicine therapies.

Clinical trials are crucial for drug development but often face delays due to poor site selection, which can lead to protocol violations, poor data quality, and increased costs. Ninety percent of clinical trials fail to meet their timelines, and issues like inadequate staffing and patient recruitment are significant challenges. Traditional site selection methods are inefficient, and the COVID-19 pandemic has further complicated the process. Data-driven insights can optimize site selection by evaluating current data on patient populations, investigators, and site capabilities.