Cardiovascular Business editor Candace Stuart recently wrote an article titled Registries & Randomization, in which she highlights the potential for administrative data and registries to fill in the gaps in randomized controlled trials. This editorial was a follow-up to her cover story, Newest Frontier in Cardiac Care: Kidneys, which examined the clinical results of renal denervation procedures on hypertensive patients.
According to Stuart, “Many randomized clinical trials are ongoing to evaluate safety, efficacy and short- and long-term outcomes for patients who receive (renal artery denervation to treat a variety of cardiovascular conditions.)”
She points out that randomized controlled trials often get criticized for not representing “real-world” patients who get treated in clinical practice. The truth of the matter is, study sponsors often can’t enroll “all-comers” for ethical or practical reasons. As Stuart states, “Studies using administrative data and registries help to fill those gaps by including a broader selection of patients, settings and physicians. These, too, have their faults; since patients aren’t randomized, the findings are subject to unmeasured confounders.”
This is where registry databases come into play. Investigational and registry databases are becoming increasingly robust and seen as a tool to track outcomes. In my opinion, anytime we can actually measure the outcome/benefit of a device or drug, we should. Registry databases (especially those that are therapeutic-specific) help validate data from randomized controlled cardiovascular clinical trials.
On the medical device side – there are important health benefits that CV device patients can gain through registry databases and added registry studies.
As Stuart points out in her article, physicians in Europe routinely encourage colleagues to participate in registries to identify potential complications. Global registries have been created to evaluate CV medical device uses in clinical practices. Stuart considers these advances a start and I agree. What’s your opinion? Would love to hear your feedback.