Real World Evidence (RWE): do you need to act on it 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 practice. Data will then be extracted from such sources as patient records, insurance claims, health apps, wearables or even social media,

In theory, RWE sounds like exactly the innovation the healthcare industry needs to make faster strides forward. But as with so many new technologies, there are more than enough challenges. In this blog, we’ll dive into the pros and cons of Real World Evidence and see how the balance tips. As a Contract Research Organization (CRO), do you want or need to do something with it now, or is it still far off in the future?

The benefits of Real World Evidence

✔️ Easier to find suitable participants

For most clinical trials, participants are recruited by placing advertisements. So what happens next? A link is shared on social media and those who feel called can respond. Registrants then go through an entire screening process to determine if they are indeed suitable to participate in the clinical trial. These are time-consuming steps that cost a lot of money before the study can start at all. With Real World Evidence, recruiting subjects becomes a lot easier. For example, you can easily see in a hospital’s electronic patient record (EPR) which patients meet specific characteristics needed for the clinical trial. You can actively approach them to participate in the study. This saves preliminary research, time and money.

✔️ Greater diversity of subjects

In traditional clinical trials, strict criteria are used to select participants. This can lead to a lack of diversity, which limits the generalizability of results. Because Real World Evidence uses data from a variety of sources in a variety of subjects, the results are more representative and more widely applicable.

✔️ Faster understanding of effectiveness and thus better decision making

It can take years and years for a traditional clinical trial to collect enough data to draw conclusions. With RWE, researchers can access more data from more subjects in real time, significantly reducing the turnaround time. Researchers, physicians and policymakers can therefore make faster decisions about the effectiveness and safety of treatments. This can lead to improved patient care and more efficient health care systems.

✔️ Cost savings because you use existing data

Clinical trials are expensive. Pepper expensive. By not collecting new data, but using existing data from patient records, insurance claims and health apps, among others, the cost drops significantly. It also speeds up the turnaround time of a study, providing further cost savings.

The challenges of Real World Evidence in clinical research.

1. System integration: how do you link all 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 organizations often use different software platforms that are not (yet) compatible. This makes it difficult to share and deploy data for clinical trials that want to use Real World Evidence.

2. International security and privacy laws and regulations.

Complying with strict laws and regulations is a second challenge. Data managers worry about data security and fear data breaches. This is an understandable concern when linking systems, given the sensitive nature of the information. Compliance with strict data protection laws and regulations is thus crucial to maintaining the trust of patients, healthcare providers, researchers as well as data managers. Especially when international parties will be working with each other, each of whom must comply with their local laws and regulations.

3. Data storage: in which country?

If the data remain within the country’s own borders, the “problem” can usually be overcome. But if European countries start cooperating with, say, the United States, Canada, Australia or Asia, then a real challenge begins. Data storage requirements are different everywhere, so what applies? Many healthcare institutions prefer to keep their data in-house and store it locally. However, this can drastically limit the potential of RWE, because collaboration and data sharing are precisely what is needed to extract valuable insights.

Can RWE’s challenges be overcome?

Understandably, there is some reluctance to link systems globally because of concerns about data storage, privacy, local laws and regulations and the integrations to be made between software systems. While the challenges are real, there are solutions.

Advanced encryption techniques and strict compliance with internationally drafted laws and regulations can help ensure data security. Collaborations between different CROs and healthcare organizations can lead to standardization of systems and protocols, making integration easier. Moreover, the benefits of Real World Evidence are too great to continue to ignore. The cost of clinical research decreases, while results that are representative of a larger group of people are obtained more quickly.

Can RWE be safely used in clinical trials (now)?

With the right approach, we can implement RWE safely and effectively, so that together we can take patient care to the next level and implement more efficient healthcare systems. Perhaps primarily at the local level for the first few years, but then globally as well. In any case, every step forward is one in the right direction.