The Editor of the Lancet Healthy Longevity commissioned a commentary for our work on clinical trials
Commentary for our clinical trial external validity study written by Nancy Dreyer.
Nancy aptly summarised the impact of our study in a few key sentences.
“The void of information in RCTs on the most vulnerable patients is a concern. Although RCTs have the central role in determining the extent to which a treatment works, there is little evidence about vulnerable subgroups. Clinicians, patients, and payers typically use the assumption that treatments will be as safe and effective in vulnerable groups treated in real-world settings as they are in patients without complications treated in optimal practices and settings. But we know that this is not always true.”
“We have long known that many populations are underrepresented in RCTs and that it is unrealistic to expect head-to-head trials for every intervention and combination, in every patient subgroup of interest, and in situations that closely mimic routine care. Calling this situation a gap sounds more like a crack in the sidewalk than the chasm described here. Why not guide decision making with both RCTs and real-world evidence?”
Thank you, Nancy, for the thoughtful overview of the impact of our work.