Although real world evidence (RWE) is gaining steam in the healthcare industry, it doesn’t pose a threat to traditional clinical trials. Here’s what sponsors and CRO’s need to know:
The mHealth boom has revolutionized the healthcare industry for patients, doctors, and now clinical trials. The patient data collected from wearable health devices is an invaluable source of information, empowering patients to manage their own health and helping physicians curate individualized treatment plans. As such, it makes sense that industry giants like Apple have already leveraged the popularity of real-world data sources to power virtual clinical trials.
With the widespread enthusiasm for real world evidence (RWE), some sponsors and CROs are concerned that new data sources may replace randomized clinical trials (RCT). However, a recent study shows that despite the value of RWE, it is not a threat to more traditional clinical research. Instead, combining RWE and RCT can help sponsors and CROs run more efficient, patient-centric trials.
Recent Study Scrutinizes The Role of RWE in Clinical Trials
On the surface, using observational methods and real-world data sources as evidence in clinical trials seems like the perfect solution. Medicine is meant to be used by real people going about their everyday lives, and real-life doesn’t always match the tightly controlled variables of a traditional clinical trial. In fact, many study participants end up not adhering to research requirements because the trial isn’t patient-centric enough to be sustainable. It therefore stands to reason that RWE would offer more nuanced insights into a treatment’s efficacy and safety.
However, a recent study has found that RWE alone is not enough to conduct thorough clinical research. A report published in the Journal of the American Medical Association discovered that real-world data sources could be used to replicate only 15 percent of general medicine clinical trials.
The reason why RWE’s use-value is so limited is that there are some things that electronic health data just can’t do. Out of the 220 clinical trials investigated by JAMA, 61% involved subjective clinical documentation like nurses’ notes that could not be gathered from EHRs. This might seem like a small hiccup, but providers’ insights supplement raw data with valuable expertise. For this reason, it’s unlikely that RWE will ever be able to replace clinical trials.
RWE and RCT Only Enhance Each Other
However, the study’s findings don’t mean that real-world evidence has no place in clinical trials. Industry leaders like Exploristics CEO Aiden Flynn advocate for a hybrid approach that uses RWE in trial design to determine whether or not a drug is feasible for a particular disease or patient pool. After RWE pushes a trial through its preliminary stages, standard RCT best practices take over in order to see a trial to completion and yield actionable results. RWE is also better suited for examining the long-term effects of a drug on a certain population after a clinical trial has ended.
Further, a clinical trial that utilizes both RWE and RCT has interesting implications for diversity in clinical trials. Medidata’s SHYFT Analytics head of research Aaron Galaznik asserts that RWE can “better tackle [a] broader variety and heterogeneity of populations than you can recruit in a single clinical trial,” which yields a more comprehensive cross-section of patients with the same condition. Since people of color only make up 16 percent of trial participants at most, RWE would help fill in critical gaps in clinical research by tapping into a more diverse patient pool.
Digital Outreach Is Essential, Regardless of Trial Type
Clinical trials, with or without RWE components, are only as good as their patient pool. Therefore, sponsors and CROs must invest in smart patient recruitment strategies to ensure that a trial gets published on time.
Research shows that patients are interested in clinical trials but can’t find enough information about them. To rectify this, sponsors can invest in SEO and paid search advertising to reach a wider audience on a variety of search engines. Targeted Facebook and Instagram ads can also help researchers access over two million potential participants across all social groups, locations, ages, and races. Further, online patient communities — such as forums, message boards, and support groups — offer the chance for sponsors and CROs to connect with patients via display ads or email outreach.
Clinical trials are still the gold standard when it comes to drug development, but incorporating RWE as well ensures that sponsors and CROs never miss an opportunity to engage patients. With the help of strategic digital outreach, these diverse and efficient clinical trials are more likely to meet their publication deadlines and bring innovative new treatments to market.