In an analysis supported by the FDA, researchers at Duke University Medical Center suggest that current diabetes trials are not addressing important clinical care issues. According to their data, only 10% of trials focused on prevention.
“It’s important that clinical trials enroll patients who are representative of populations affected by diabetes and its complications,” researcher Jennifer Green, MD, associate professor at Duke University School of Medicine and member of the Duke Clinical Research Institute, said in a press release. “Our study is just a snapshot in time, but it can serve as a guide for where we need to focus attention and resources.”
Green and colleagues created a subset of 2,484 interventional trials by selecting studies registered on clinicaltrials.gov to examine whether current studies address the prevention of diabetes and its complications.
According to data, 74.8% diabetes-related trials primarily had a therapeutic purpose, whereas 10% were considered preventive. These therapeutic interventions included drugs (63.1%) and behavioral (11.7%), researchers wrote. Additionally, most trials were designed to enroll fewer than 500 (91.1%) or 100 (58.6%) patients, with mean completion periods of 1.8 years.
Furthermore, a small percentage of trials reportedly targeted patients aged 18 years or younger (3.7%) or aged at least 65 years (0.6%), whereas 30.8% excluded patients aged older than 65 years and the majority excluded patients aged older than 75 years, researchers added.
“When trials are excluding patients who are older or younger, it’s questionable whether the trial findings can be applied to people in those age groups,” Green said. “We really don’t understand how best to manage disease in these patients , particularly among patients of advanced age. So the exclusion of them from most studies and the small number of trials that specifically enroll older individuals is problematic.”
Moreover, Green and colleagues reported that funding sources included industry (50.9%), NIH (7.5%) or other, with most being single-center trials of other sponsorship (37.7%) or industry-funded multicenter studies (27.4%). Only 1.4% of trials listed primary outcomes that included mortality or clinically significant cardiovascular complications, according to data.
“We will see many more such trials in the future, given the recent emphasis on assessing diabetes medications for cardiovascular safety,” Green said.
Green and colleagues wrote that recently registered diabetes trials may not adequately address issues needed to inform evidence-based practice.
Disclosure: The researchers report no relevant financial disclosures.