When conducting clinical trials, there are many factors that need to be taken into account, such as the patient population, the treatment protocol, the research team, and the outcome measures. If there are too many variables to account for, it will be difficult to identify the most effective clinical trial protocols. That’s why it’s important to collect real world data in clinical trials.
This post will discuss how to use real-world data in clinical trials and how it can benefit your research. You’ll learn how to collect data in the real world and how to analyze the data. You’ll also learn about the benefits of real-world data in clinical trials.
What Is Real World Data & How Is It Used?
According to Timothy Hoctor, the vice-president of Elsevier describes real world data as a by-product of day-to-day patient care. It is typically obtained from different sources like electronic health records, patient registries, patient research networks, insurance databases, and even social media.
Previously, data obtained from randomized research trials was considered the gold standard for drug and treatment development. In the last ten years, medical regulators have been using real world data as an effective way of informing drug approval and labeling expansion decisions.
The US Food and Drug Administration (FDA) made their first label expansion in April 2019 purely based on real world evidence. The treatment in question is Palbociclib (Ibrance), a drug for treating male breast cancer. The evidence that was used was obtained from post-marketing records and electronic health records of the drug’s use in men.
The Benefits of Real-World Data
Real world evidence is associated with several benefits such as:
- Real world data results in more effective treatment development programs
- Real world data significantly reduces the number of volunteers that would be exposed to less efficacious drugs or therapies
- Real world data expands a drug’s safety profiles
- Real world data offers a broad understanding of the different patient journeys, drug effectiveness levels, and treatment pathways
- Real world data contributes evidence to encourage expanding the indication of a particular drug or therapy
The Challenges Facing Real-World Data and Possible Solutions
The very things that make real world data strong – its diversity and breadth – are the same things that make it challenging to use. Since the collected data is not for research purposes, there is a lack of data standardization and the computer systems to be used. As a result, it introduces bias in the data.
Another significant challenge of using real world data beyond the clinical setting is the problem of privacy and confidentiality. The companies that safeguard the information often hesitate to share it because if there was any data leakage, they’d be blamed.
The advantage of technology is that it allows people to offer a measure of standardization and uniformity and make it research-ready. The FDA has dedicated itself to managing the problem of data standardization by launching an open-source app known as MyStudies.
This app aimed to facilitate the input of real-world data by various patients on a single platform. It can be synchronized with the patients’ electronic health records, and also help with patients’ assessment into clinical and research trials.
Real World Data in Clinical Trials Summary
Real world data refers to information related to the health status of patients and the delivery of healthcare from a wide range of sources. RWD is obtained from multiple sources such as electronic health records, disease and product registries, billing and claims activities, patient-generated data, and more.
RWD comes with numerous benefits, including significantly reducing the number of volunteers who’d be exposed to less efficacious treatments. However, its major drawback has been the concerns regarding data standardization. Fortunately, the FDA has designed a secure app to help in monitoring safety, ensuring standardization, and maximizing the efficiency in product development.
At the moment, it remains to be seen how real-world data will be incorporated into clinical trials and the overall healthcare as well.