Can Real World Evidence (RWE) now be considered a universal approach? For better or for worse, the stars seem to have aligned in its favor. In a world gripped by a crisis such as COVID-19, it is difficult to continue to run traditional clinical trials involving patient visits to clinics. Simultaneously, regulators are placing additional focus on the use of RWE to support regulatory decision making.
Whether you are a pharma, OTC or device manufacturer, RWE can bolster your brands.
RWE can contribute to achieving multiple objectives:
1. Pragmatic clinical trials to support marketing authorizations.
2. Approval of new indications for marketed products.
3. Advantages in patient sub-groups not studied in the pivotal clinical trials.
4. Development of clinical practice guidelines.
5. Coverage decisions.
6. Post-marketing surveillance and post-marketing clinical follow-up (ideally linked to product lifecycle management).
RWE can come from various sources:
7. Electronic health records (EHRs).
8. Claims and billing activities.
9. Clinical registries.
However, the data from these sources is retrospective in nature. In Regen Med’s experience, the most balanced approach is:
10. Burden-free capture of longitudinal patient outcomes using a web-based platform which comprises comparative analytics to correlate treatment factors and clinical profile.
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