Pragmatic trials offer real-world data on the efficacy of a treatment — and an opportunity to take advantage of new medical technology.
If there’s one constant in medical research, it’s that conducting clinical trials is expensive and time-consuming. Rigorous approval standards and patient criteria make recruitment and retention expensive for medications in trial phases. But all that investment doesn’t guarantee that the results of a trial will be useful — or even applicable — to a general population.
Sponsors and CROs are increasingly relying on pragmatic trials — research conducted on everyday patients in everyday health care settings — to provide important insight into the real-world effects of treatments. Even better, these trials provide opportunities to implement technology that might not yet be accepted into a more traditional research environment. Read on to learn more about pragmatic trials and why they’re the future of clinical research.
What are Pragmatic Trials?
The goal of traditional clinical research is to find causative explanations for why a therapy works. As a result, this research must occur in highly controlled settings — with ideal patient populations that don’t have complicating conditions.
But trial data sets don’t always need to meet strict criteria to be useful to patients and the medical community. Pragmatic trials test the same interventions as clinical research, but in a real-world medical setting like a hospital or clinic. Participants may be randomized at the group level instead of trial-wide, and might also have chronic conditions like diabetes or heart disease that would otherwise exclude them from clinical research.
Pragmatic research provides valuable information to the medical community about the real-world efficacy of a drug. When trials take place in a highly controlled environment, drug developers often see a drop in effectiveness when the drug hits the market. Pragmatic trials should by no means replace traditional research, but it can help reveal complications with a medication after federal approval that may not have shown up during initial trials.
The Role of Technology in Pragmatic Trials
In addition to their medical benefits, pragmatic trials offer a unique opportunity to incorporate new technologies into clinical research. Because the drugs being tested have already been approved and sent to market, sponsors and CROs can relax rigid standards about obtaining real-world data through digital technology.
For example, electronic data capture methods can enable patient participation using their own devices, known as a “bring your own device” or “BYOD” method. In addition to viewing their health information through a digital portal, participants could engage with video content about their condition or communicate with a chatbot on their own computer or mobile phone.
These innovations align with the growing trend of patient centricity in clinical trials. More patients are seeking out clinical trial information in search or on social media, and expect that there will be minimal barriers to enrollment. By using BYOD methods in pragmatic research, patients will only have to make minimal lifestyle changes to participate.
With the help of technology, pragmatic trials can gather real-world-applicable data more efficiently while maintaining regulatory compliance and minimizing the burden on trial participants. Though traditional explanatory research will always be necessary and valuable, trial sponsors and CROs would do well to invest in pragmatic trials to ensure better outcomes for real-world patients.