RWE and the FDA (Part 1)
What are RWEs or Real World Evidence about?
How are Real World Evidence used in determining the value of clinical trials on how they are applied in real-life settings?
How are RWEs validated and how are they used in actual medical cases as healthcare procedures are applied in hospitals?
What variables tend to affect the way RWE data is managed and used as a reference to actual medical developments?
How does accurate reporting affect the value of collected RWE data?
Clinical trials accomplished to support the development of healthcare industries around the globe are critically defined to the references on how health conditions are diagnosed and treated.
In the end, the real target end-users of the medicines and other medical procedures are the patients. Hence, creating a more patient-centered approach in handling clinical trials is an important part of defining the success of one study.
One way of making sure that the clinical trials reflect real-world situations is through inculcating Real World Evidences or RWEs. Often, these evidences are garnered through observing samples that are free from the manipulation of the researchers. Through EHRs or Electronic Health Records, statisticians are able to collect data without necessarily influencing the sample population that they have chosen to observe. How does the FDA consider these factors of evidence?
Listen to Josephine Wolfram, an expert in RWEs, and me, and learn more about the way the FDA sees the value of RWEs and how this factor affects the overall procedures considered when approving new medicines and medical procedures that are offered for patients to consider.
Here are some key takeaways to look forward to when listening to this podcast: