- Clinical trials are time-consuming, expensive, and not representative of a broad patient population. Additionally, cancers increasingly stratified by molecular subtypes question the exclusive use of these clinical trials for regulatory decision-making.
- Physicians use a variety of subjective and objective indicators to determine whether a treatment is working, how you measure “success” in the real world is different than measuring “success” in a controlled setting. Based on these principles, the former FDA Commissioner Scott Gottlieb, M.D. announced in December 2018 that real-world data use should be a strategic priority to improve regulatory decision making.
- RWE could accelerate the drug approval process while providing a better understanding of how a new therapy works for assessing long-term outcomes in patient groups after they leave the clinical setting. Physicians can compare their patients’ genetic makeup with others who are very similar to discover which treatments work best for them. The patient’s appropriate treatment path is consequently identified as soon as possible, and costly treatments ineffective in clinically similar patients can be eliminated.
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SVMPharma is an innovative strategic consultancy, specialising in Real World Evidence (RWE) for the pharmaceutical industry. SVMPharma generates RWE within UK and Europe through bespoke online Real World Treatment Evaluators, leading to successful health technology appraisal (HTA) submissions. Clinical trial programmes do not reflect real-world clinical practice and outcomes, RWE supplements and enhances clinical datasets. SVMPharma’s specialist teams focus on delivering the outcomes that matter to your brand.