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 The Round Table Conference on “Real-World Evidence (RWE) and Post-Marketing Surveillance (PMS) Studies” brought together eminent experts from India, Switzerland and across Europe to discuss the future of RWE. The event, which concluded in Mumbai recently, addressed critical issues such as optimizing resources, reducing timelines, and enhancing regulatory compliance in the conduct of RWE & PMS studies.
Dr Chirag Shah, head of clinical operations at Raptim Research, emphasized the growing significance of RWE in modern drug development. He noted, “With regulatory agencies worldwide placing increasing emphasis on evidence-based research, it is imperative to streamline and scale RWE methodologies for more economical and efficient outcomes.”
Dr Shah further elaborated on the importance of RWE in bridging the gap between Indian and European regulatory landscapes. “India’s flexible and cost-effective regulatory environment and data management capabilities can complement Europe’s structured frameworks, ensuring faster and more reliable outcomes,” he added.
Recently Palbociclib in breast cancer and Abatacept in GVHD got an additional indication approval based on RWE data that demonstrated the power of RWE. These approvals underscore how real-world data can expedite drug development and regulatory decision-making.
Dr Shah informed that between January 2019 and June 2021, 136 new products were approved by the US FDA based on Real world evidence —a testament to the growing reliance on RWE. Real world data is proving instrumental in determining target populations and refining indications. However, concerns regarding data accuracy and reliability persist, especially in hospital-generated health data.
Key challenges in RWE implementation are data challenges – availability, integration, standardization, and real-time collection, regulatory and compliance issues – variability across regions, data privacy concerns, operational hurdles – investigator engagement, patient recruitment, resource constraints, study design complexities – bias, confounding factors, long study durations, technology gaps – interoperability issues, digital literacy limitations, budgetary concerns – high costs and cost-effectiveness concerns, stakeholder collaboration – aligning multiple stakeholders, ensuring patient-centric approaches, ethical and practical concerns – informed consent, ethical data, use.
On the occasion, Swiss-based Wemedoo unveiled its cutting-edge software, designed to optimize Real World Data (RWD) collection and analysis. “This innovative tool called as OOPUS and OOMNIA improves access to high-quality RWD, increases efficiency and cost savings, shortens study timelines, enhances data quality and integrity, supports innovative study designs, ensures compliance with global regulatory requirements and strengthens partnerships with healthcare institutions,” stated Dr. Nikola, oncologist & founder, Wemedoo, Switzerland and Dr Dhiraj Patel, director, Velocious Clinical Research.
The event witnessed active panel discussion moderated by Dr. Kamlesh Patel, head- medical affairs, clinical research & health tech, Lupin India, Mumbai along with other expert panellists from industry, Dr Santosh Taur, chair, RWE Council, Indian Society of Clinical Trials (ISCR) Mumbai, Dr Chintan Khandhedia, lead - clinical research, RWE, Sun Pharma, Ramneek Kour, global project manager, Abbott, Bengaluru, Dr Jyoti Bajpai, lead, medical & precision oncology, Apollo Hospital, Navi Mumbai. The list also included Dr. Chetan Gharat, head-medical services, Lupin Digital Health, Dr Hari Kiran Gellela, senior patient engagement and recruitment specialist, BMS, India and Veerababu Yegi, head biostatistician, Raptim Research, Mumbai, and Dr Rajen Shah, director, Raptim Research.
Experts reiterated the urgency of adopting economical, scalable, and smart RWE solutions stating, “The real-world impact of RWE is undeniable. By harnessing technology, improving collaboration, and streamlining regulatory pathways, we can redefine the future of RWE & PMS studies globally.”
“With the pharmaceutical industry increasingly leaning towards evidence-based decision-making, RWE is poised to become the cornerstone of future drug approvals, ensuring better patient outcomes and more efficient healthcare systems worldwide,” Dr Shah explained.
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