Clinicians across more than 30 VA medical centers are taking part in a $10 million randomized clinical trial meant to compare two common treatments for hypertension. These doctors will not, however, noticeably change how they treat their patients or how they collect data about them.
In fact, after veterans are enrolled in the trial, they will be asked to continue managing their blood pressure using their regular doctors, unlike in the vast majority of clinical trials where new doctors treat patients and study staff oversee them.
The trial that kicked off earlier in August is a test case in an initiative that's trying to revolutionize how clinical trials are performed through the use of health information technologies, researchers told me. If successful, they could save the federal government millions of dollars on research each year and make it easier to answer long-standing questions about efficacy of certain medicines.
“There are many questions in medicine, and big trials could give us answers, but they can be expensive and take a long time,” Frank Lederle, an internist who heads the study and works in Minneapolis for the Department of Veterans Affairs, told me.
By taking advantage of the VA's integrated electronic health record system and informatics staff, the administrative costs of Lederle's trial won't increase with its sample size, as is typical for most clinical trials, Lederle said.
Lederle and his colleagues estimate they'll spend a twentieth of the amount of money spent on similar clinical trials. In a letter about the study published Aug. 16 in the Annals of Internal Medicine, the researchers estimated they'll spend about $700 per patient enrolled in the study, a fraction of the $15,000-per-patient cost of the National Institutes of Health's Systolic Blood Pressure Intervention Trial (SPRINT).
If successful, researchers hope they'll have a model for cheaper clinical trials that could be used both inside and outside the VA. The work has implications for efforts across the health-care industry to reduce the cost of drug development and medical research.
However, the agency has a number of advantages over private-sector organizations that make this kind of research difficult outside the VA.
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