Real World Evidence (RWE): Should you act now or can it wait?

Real World Evidence (RWE) promises to revolutionize clinical research. By collecting data outside the controlled environment of traditional clinical trials, researchers can better understand how treatments work in real-world settings. This data can come from sources such as patient records, insurance claims, health apps, wearables, or even social media.

In theory, RWE seems like the exact innovation healthcare needs to accelerate progress. However, as with many new technologies, there are also plenty of challenges. In this blog, we dive into the pros and cons of Real World Evidence and explore where the balance lies. Should Contract Research Organizations (CROs) act on it now, or is it still a distant future prospect?

The Benefits of Real World Evidence

✔️ Easier Recruitment of Suitable Participants
For most clinical trials, participants are recruited through advertisements. What happens then? A link is shared on social media, and those interested can respond. Applicants then go through an entire screening process to determine if they are indeed suitable for participation in the clinical study. These are time-consuming steps that cost a lot of money before the study even starts. With Real World Evidence, recruiting participants becomes much easier. For example, you can simply check the electronic patient records (EPR) of a hospital to see which patients meet the specific criteria required for the clinical trial. You can then actively approach them to participate. This saves time, pre-research, and money.

✔️ Greater Diversity of Participants
Traditional clinical trials often use strict criteria to select participants, which can lead to a lack of diversity, limiting the generalizability of the results. Since Real World Evidence draws on data from various sources and participants, the results are more representative and broadly applicable.

✔️ Faster Insights into Effectiveness and Better Decision-Making
It can take years before a traditional clinical trial collects enough data to draw conclusions. With RWE, researchers can gain real-time access to more data from more participants, significantly reducing the trial timeline. Researchers, physicians, and policymakers can make faster decisions about the effectiveness and safety of treatments. This can lead to improved patient care and more efficient healthcare systems.

✔️ Cost Savings by Using Existing Data
Clinical trials are expensive. By using existing data from sources such as patient records, insurance claims, and health apps, instead of collecting new data, costs are significantly reduced. Moreover, this accelerates the timeline of a study, leading to further cost savings.

The Challenges of Real World Evidence in Clinical Research

1. System Integration: How Do You Link All the Software Packages?
One of the biggest challenges in implementing RWE is that many systems do not yet communicate with each other. Hospitals, insurers, CROs, researchers, and other healthcare institutions often use different software platforms that are (still) incompatible. This makes it difficult to share and utilize data for clinical trials that want to leverage Real World Evidence.

2. International Regulations on Safety and Privacy
Complying with strict regulations is another challenge. Data managers are concerned about data security and fear data breaches. This is an understandable concern when linking systems, given the sensitive nature of the information. Meeting the stringent data protection regulations is crucial to maintain the trust of patients, healthcare providers, researchers, and data managers. Especially when international parties are involved, each must adhere to their local regulations.

3. Data Storage: In Which Country?
If data remains within the country’s borders, the ‘problem’ is usually manageable. But when European countries collaborate with the United States, Canada, Australia, or Asia, a real challenge begins. Everywhere, the requirements regarding data storage differ, so what rules apply? Many healthcare institutions prefer to keep their data under their control and store it locally. However, this can drastically limit the potential of RWE, as collaboration and data exchange are critical to deriving valuable insights.

Can the Challenges of RWE Be Overcome?
It’s understandable that there is some hesitation in linking systems globally due to concerns about data storage, privacy, local regulations, and the software integrations required. While the challenges are real, solutions are available.

Advanced encryption techniques and strict adherence to internationally established regulations can help ensure data security. Collaborations between different CROs and healthcare institutions can lead to standardization of systems and protocols, making integration easier. Moreover, the benefits of Real World Evidence are too significant to ignore. The costs of clinical trials decrease, while results are achieved faster, representing a larger population.

Can RWE Be Safely Used in Clinical Research Now?
With the right approach, we can safely and effectively implement RWE, allowing us to elevate patient care and implement more efficient healthcare systems. Perhaps in the first few years primarily at a local level, but eventually globally. Every step forward is a step in the right direction.