Know About the Role of Real-World Evidence in Clinical Trials

Know About the Role of Real-World Evidence in Clinical Trials

For the clinical research industry, advanced technology has enabled researchers to collect a massive amount of real-world data. Real-world evidence, or RWE, can assist researchers in understanding how a patient’s health status and behaviors can affect outcomes. It also helps demonstrate the efficiency of a drug or digital technology solution to treat certain diseases or health conditions in a real-world setting, allowing researchers to make more informed decisions about the treatment or drugs to be presented to patients. Real-world evidence involves data from pharmaceutical databases, clinical settings, clinical studies, claims, and patient advocacy communities. This RWE data is further investigated to create insights regarding the implementation of medical products, which can help improve treatment efficiency and patient outcomes.


Here is how real-world evidence helps clinical trials and development.

Enhanced Development of New Therapies

Real world evidence acts as a powerful tool for accelerating the development of new medicines and therapies by positively influencing the design of clinical trials. It advances researchers’ understanding of how specific therapies work in certain conditions for different people and ensures that the therapy is safe and effective for all ages. The available real-world data can help researchers develop drugs and therapies at the optimal level, ultimately enhancing the overall healthcare system for the better.

Improved Evidence in Clinical Trials

The medical data used in real-world evidence is collected from electronic health record (EHR) systems and insurance files. They are used to check the occurrence of drug-related adverse effects, including blood clots, infections, and strokes. Real-world evidence also presents the chance to recognize unexpected side effects due to the amalgamation of different drugs. They can be used to calculate consequences such as strokes in heart patients or disability from a heart attack.

Study-cases for Physicians

Doctors and physicians can use RWE to determine the most effective therapies or medications for their patients. They can use the results of available care studies and their effects on patients with the same demographics. A healthcare provider will find it easier to decide the correct course of action or treatment as they can efficiently check the benefits and side effects of specific medicines and treatments through RWE.

Post-Market Surveillance

When a therapy or drug is approved and launched in the market, RWE can help the pharmaceutical company understand details about their products, including value, effectiveness, safety, off-label use, and more. The purposes of post-market surveillance are compliance with regulatory requirements, comparing new products or treatments, detection of adverse events or risks, etc. Moreover, RWE assists in research across the product lifecycle for digital health tool makers and pharmaceutical companies. It can update pre-clinical trial studies by allowing researchers to identify patients and craft inclusion criteria for the trial.

Assessment of the Healthcare System

Real-world evidence can be used by administrators and regulators to check their healthcare system performance. RWE provides relative data on doctors and their treatment procedures. As the resources to collect data are increasing, researchers, doctors, and healthcare professionals have an abundance of data to develop a more effective healthcare system.

So, RWE can lead to faster and safer therapies based on clinical practice guidelines. Healthcare companies can leverage this to build a comprehensive and futuristic RWE strategy and boost customer experience consulting services.