01 Feb RWD and RWE will play an increasing role in health care decisions
Real World Data (RWD) and Real World Evidence (RWE) will be surely changing the way we track medicine’s efficacy and safety.
RWD, compilation of all patient’s healthcare information has constantly increased with the automatic use of computers. RWE derives from the analysis of these stored data and delivers clinical evidence regarding the usage and potential benefits or risks of a medical product.
As the FDA notes:
- RWD and RWE will most likely be used to monitor post-market safety and adverse events and make regulatory decisions.
- These Data will also contribute to support decisions from the health care community and develop guidelines for clinical practice.
- RWD and RWE will finally become essential to support clinical trials designs and observational studies leaded by medicinal products developers.
RWE is not a new concept, but it is now benefiting from advances in technology, data access and storage, and most importance data analysis.
But when it comes to data, the most important issue will certainly be regulation and standardization. Will then ask the question of how to incorporate RWE in the market access process. Until then, randomized controlled trails will continue to have an major role.
Opportunities are ahead if RWD and therefore RWE are reviewed, compiled and monitored by top data analysts, whom not only have the “Google data management” profile but a career in life sciences and a perfect knowledge in biopharmaceuticals and health technology assessment.
For more information: Seizing opportunities in the next steps for real world evidence