Real World Data In Clinical Trials

Clinical trials are scientific or medical research studies performed for evaluating a medical, surgical, or behavioural intervention. For example, scientists and researchers use clinical trials to determine if a new treatment, like a drug or medical device, is safe and effective for use. However, it is also worth noting that the purposes for clinical trials may differ. Regardless, clinical trials are typically focused on the efficacy and safety of treatments and medicines. As ObvioHealth explains (, most of them have turned to real-world data to understand how patients respond to drugs and other treatments once they are approved for use.

What Is Real World Data?

Real world data (RWD) is medical data captured at the point of care or in an actual clinical situation. The data can also be based on a patient’s experience outside a clinical setting. Real world data is used in clinical trials and various drug and treatment development phases as supportive evidence. It is also commonly used as one of the guides for decision making in drug development and regulatory processes. In simpler terms, RWD is a distinct form of data obtained from randomized patient data.

How And Why Is Real World Data Used In Clinical Trials?

Researchers use real world data to understand when and how patients use treatment and respond to a drug. The information helps researchers and medical practitioners whether a medication is suited to remain in the market or not. It also helps them determine the right market or patient group for a particular medication or treatment. The data can also help researchers and scientists determine the right candidates when recruiting subjects for clinical trials. In other words, RWD is useful for designing clinical trials. Real world data allows researchers to find answers to top research questions. Below are reasons real world data is beneficial in clinical trials:

  • This data allows researchers to acquire data from relevant sources. As a result, they can focus on data related to the purpose of their clinical study. For instance, they use hospitalization data or patients with strokes and heart attacks to compare cardiovascular disease medications. This beats using random data sources.
  • Researchers use RWD to meet evidentiary needs during their late research phases. The information can be provided to regulatory bodies as evidence of the efficiency and performance of a novel treatment. However, most regulatory bodies require you to provide additional evidence besides RWD.
  • The data also helps doctors make informed decisions regarding appropriate medicines and treatment options for certain patient groups. In addition, they can use real world data to analyze the performance of the medications and how patients react to them. This helps them make better decisions with future patients.
  • Researchers and medical practitioners can also use real world data to compare the effectiveness of medicines and treatments. For example, some diseases have a wide range of treatment options. Most of these treatments aren’t usually directly compared in clinical trials as they have different manufactured and were produced at varying times. However, real world data can be used to compare their performance and effectiveness and determine the one that works best.
  • Financiers can also use real world data to determine medicines that can reduce healthcare costs. They can do this by looking into the most effective treatments that reduce patients’ time in hospitals. The data is also used to pick medicines that minimize patients’ chances of going back to the hospital after treatment.
  • The data can also help decrease study costs and the costs of post-market surveillance. RWD requires fewer resources for efficient data sourcing and observational studies. Therefore, they are a cheaper alternative for traditional post-market surveillance.

How Is The Data Collected?

Real world data is usually collected from electronic health records, patient registries, insurance databases, social media, and patient research networks. The data can also be gathered from pharmacies and devices

Real World Data In Clinical Trials: Wrapping Up

With real world data, there are fewer market delays during clinical trials. This is primarily because all the data is usually readily available. It also helps that there are numerous sources of real world data. Researchers, medical financiers, sponsors, patient advocates, regulators, and other key stakeholders in the medical industry recognize the importance of real world data in clinical trials. This has led to an increase in RWD applications in clinical trials.

Amanda Kremer