Fast Launch; Long Tail
Regulators around the world are making it possible to get novel and high-potential treatments to patients faster. Through changes in regulations and approaches to review, they’re making it possible for true fast tracks as well as more efficient clinical protocols.
With speed to launch comes a new expectation: more real-world evidence and data. That real-world data has been considered a post-launch cost and commitment in years past, but RWE strategy is moving left on the development timeline. The clear focus in 2021: using RWE to enhance the research and development process, including supporting regulatory filings and augmenting clinical trials. That’s an easier realization of value for companies that have already invested in RWE; others will spend the year building to catch up.
Where will real-world data and evidence have the most impact on our total costs and market potential?
What transformation is needed in the short-term to fill any gaps?
Industry is investing in experts, technologies and medical-grade data. By 2024, the RWE solutions market is expected to be valued at $1.64 billion. Driving investment, the analysis revealed, is the need for stronger evidence of treatment impact, clinical value, and cost effectiveness in environments that look more like real life and less like the strongly controlled settings of traditional trials.
— GlobeNewswire, 2020
Time to approval is moving faster around the world. In Japan, for example, regulators are combatting drug lag (the extended amount of time it can take for Japanese patients to get access to new treatment vs. the rest of the world) by changing their expectations for Phase 1 / Pharmacokinetics (PK) studies. Those no longer have to be done strictly in region, allowing Japan to more easily be part of global clinical trials.
— Syneos Health, 2020
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