The healthcare system has been evolving with the changing times. It isn’t as simple as it used to be. We now have a healthcare based on real-world evidence. This has changed the way we look at healthcare. To understand Real-World evidence (RWE) let us understand from where the evidence is collected.
The Real-World data (RWD) as the name states is collated from the various routine-care delivered and not just from clinical treatment rendered. The data is sourced from medical data records like prescriptions, lab reports, government datasets, surveys taken by the patient, data from device registries, clinical registries, and more.
Real-World Data gives a true representation of health and the care opted by the people. This data is analyzed in a structured manner to derive Real-World evidence. It is the compilation of the usage data of various medical products. Real-World Evidence (RWE) is defined by the US Food & Drug Administration (FDA) as “the clinical evidence regarding usage and potential benefits or risks of a medical product derived from analysis of real-world data.”
The actual usage of this evidence is to bridge the gap between the research results and the actual usage results of various medical products used by people. There are many ways RWE is redefining healthcare and improving the healthcare spectrum.
How is RWE used in healthcare?
Let us see how RWE is used presently in various fields of medicine for research and other purposes:
- Clinical Trials
Researchers conduct various clinical trials before they zero-in on the final product. The traditional method of clinical trials has various shortcomings, as it is conducted within a small trial group. With RWE the data collated is from a larger group with various demographics. This gives the researchers a wide range of possibilities for conducting clinical trials.
Also, they can gauge the end-result of the product as RWE has data of people who have used the product and how it had worked.
- Pre-trial research in Life Science studies
The researchers benefit from RWE and can form an accurate pre-trial design, as they can include various pre-trail criteria. This makes the clinical trial more effective.
- Product review
Pharmaceutical companies are best benefitted by RWE. They develop a product or medicine and RWE helps them to get a real-time preview of their products. This leads to further research and development of the products. One classic example is the drug Viagra. It was introduced to lower blood pressure and RWE showed it helps with erectile dysfunction. Presently it is used widely for erectile dysfunction issues.
- Regulatory approval by FDA
The RWE derived from the data is analyzed extensively that its effectiveness is undeniable. FDA has laid down clear guidelines as to how the RWE can be used to get approval for new drugs or products introduced by companies. FDA has allowed post-market studies to be included while seeking its approval. This simplifies the approval granting procedure.
- Easier Regulatory approval for pharmaceutical companies
It would be difficult to conduct a full-fledged clinical trial for a certain segment of medicines. Pharmaceutical companies can study the data available about their existing products & drugs. This data can also be included to get approval from FDA for the newer product or drugs developed under the same category.
- Study-cases for Doctors
The doctors can use the RWE to decide the most effective or the best-suited treatment for patients. They can refer to the available case-studies and their effects for patients with similar demographics. The doctor is in a better position to decide the course of treatment. He can easily study the effects, benefits, and side-effects of certain treatments through RWE. The doctor can also optimize the drug dosages after studying the past treatment history.
- Research & Development
The RWE helps in the further betterment of healthcare. The available data and evidence help the researchers to develop products & drugs to perform at the optimal level.
- Assessment of healthcare system
Regulators and administrators can use RWE to study their healthcare system performance. It provides comparative data of the doctors and their treatment protocol.
As the sources to gather data are widening; doctors, researchers, and companies have an abundance of data and evidence to develop a better health care system. It helps in taking calculated decisions & treatment options thereby reducing the risk factor to a greater extend. People are open and willing to share their experience with drugs & treatments. This gives ample scope for future research and development in medical science. Real-world evidence has become a game-changer for the healthcare system.
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