Are these studies investigating whether these drugs will help us live longer? Feel better? Reduce the pain and loss of function associated with diabetes complications?
A study in the current issue of JAMA reviewed outcomes in 436 ongoing trials. It says most of them aren't measuring what matters to patients: 1
"In this sample of registered ongoing RCTs in diabetes, only 18% included patient-important outcomes as primary outcomes."Less than 1 in 5 trials are measuring the kind of physiological outcomes that are important to patients and the doctors who treat them. What are they measuring instead? Laboratory values such as HbA1c, insulin, and cholesterol levels - values that don't necessarily predict risk for, say, a heart attack. Why? Because it saves money:
"One potential reason for the apparent increase in trials measuring surrogate end points is the preference of researchers and funding agencies to obtain results faster, with fewer patients and at lower costs."Below is a 2-minute clip featuring Victor Montori MD from the Mayo Clinic, lead author of the study, discussing the implications of trials which don't ask questions that matter to patients, leaving doctors and patients to imagine what the effect of a treatment will be:
"And imagining what the effect of treatment will be on those outcomes, they will make mistakes," says Montori.
1 Patient-Important Outcomes In Registered Diabetes Trials, JAMA, June 4, 2008.