The Misunderstood Cross-Trial Comparison
The cross-trial comparison just might be the 800-pound gorilla of drug development. We all do it. We all warn against it, even as we are doing it. The reality is that drug development is built on it, from sponsors nominating new drug candidates, to regulators benchmarking what new therapies are to be approved. Below are a few tips to consider before performing your next cross-trial comparison. Keep these elements in mind and make sure they come through in your writing.
Pay close attention to the inclusion/exclusion criteria. Even the subtlest differences in patient populations can have a profound impact on outcomes.
Consider regional differences. If you are comparing your results to a study conducted exclusively in another part of the world, it is good to remember that you are not only comparing to the drug and patient population, but also to the standard of care in that region. The same drug may not perform as well in all regions.
Consider when the study was conducted. There are significant limitations in comparing fresh results to a study conducted 10 or even 5 years ago, as the standard of care for many diseases advances quickly.
Consider the study phase and the number of patients included. Small Ns lead to greater variability. Anchoring your comparison to studies that are similar in phase is also important, as each study phase tends to enroll different types of patients with different risk factors.
Understand how the efficacy assessments were performed. Digging a little deeper can reveal that a potential comparator study evaluated efficacy in a different manner, potentially using a blinded review committee, or using different versions of the disease/response assessment.
For any safety comparison, always consider the length of follow-up (how long patients were monitored for safety). If you have two studies examining the safety of a sugar pill and one of the studies followed patients for twice as long, it’s likely the rate of AEs in that study will be twice as high.
Justin McLaughlin
Acumen Co-Founder and CEO
