RWD or clinical trials

Through the services of digital healthcare companies like, it is now easy to access real-world data (RWD) from medical practices, which has many advantages over clinical trial data. However, this raises the question for many people whether RWD can complement or replace the conduct of traditional clinical trials. In this article, we will try to get to the bottom of this question.


What is real-world data?

Real-world data (RWD) is data from daily life during a medical intervention or patient observation during recovery. This information comes from electronic medical records (EMRs), health insurance data, modern medical equipment, etc.

Of greatest value is the clinical data accumulated in EMRs. This includes disease diagnosis, medication prescription, clinical decision-making, and disease management data. Information of this magnitude and content cannot be obtained through traditional, carefully controlled and time-limited clinical trials. Therefore, EMR data are increasingly being used for analysis in medical research. The scientific community has recognized that analysis of EMR-recorded data yields better research results and improves clinician satisfaction.

Data from clinical trials

Despite the value of real-world data, the medical community has traditionally relied on randomised clinical trials (RCTs) in highly controlled settings to study drugs and medical interventions. Such studies are conducted on a group of participants, each meeting a specific list of criteria. Their main goal is to verify the efficacy and safety of drugs, medical devices, or certain procedures before they become available to payers.

This research format is considered the most reliable, scientifically sound and safe. That’s why most medical recommendations and market access for new drugs are given based on data from clinical trials.

RWD or clinical trials?

Among the disadvantages of clinical trials is that the list of criteria according to which the group of study participants is selected cannot include all variants of the individual characteristics of future patients. In other words, the study group cannot represent the entire population. This disadvantage of clinical trials is called bias. Consequently, the data obtained from RCT may not match the data obtained from the use of drugs in a variety of real-world situations.

On the other hand, research ethics do not allow the efficacy and safety of drugs to be analyzed on real patients unless they have undergone clinical trials. Most side effects of new drugs are discovered during the development phase, and if the results of a clinical trial do not meet the developers’ expectations, the drug is not marketed.

Thus, RWD and clinical trial data are complementary, not competing. Real-world data analysis helps detect rare side effects in patients with health conditions not accounted for by the selection committee. RWD also allows for a more accurate calculation of the full cost and timing of treatment using the drug or procedures being studied. In other words, data analysis from actual drug use corrects and supplements data from group studies.

By Kenneth

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