Analysts and academics have begun discussing the possibility of using real-world data (RWD) for assessing the efficacy and safety of certain products, instead of always relying on the popular randomized controlled trials (RCT).
“Data’s role in normal clinical practices, or in settings that reflect the reality of healthcare delivery, is likely to become increasingly important in ensuring that medicines are accepted by national policymakers and are adopted into practice,” according to a PMLiVE article.
RWD helps reflect priorities to ensure a well-rounded clinical development and market access plan that includes not only RCTs but also more pragmatic research in real clinical practice, the article notes. These aspects reflect the need for a change in focus toward demonstrating the value of a new medicine.
RWD is becoming crucial to decision-making in Europe when used in conjunction with clinical trials, the article continues. European authorities have made tremendous efforts to optimize RWD access and use, and new strategies are needed to align various stakeholder interests involved in healthcare.