Point-of-Care Clinical Studies

[Greenbeard]

Some news this week regarding a project piloting a relatively new development in the process of using electronic health records (EHRs) to build a learning health care system: point-of-care clinical trials.

How Point-of-Care Trials Work

For the pilot project, specialists programmed Boston VA's EHR system to assist in clinical trial recruitment. When a physician submits an order for insulin treatment, the system recommends two standard regimens and a third option, labeled "no preference."

If the physician chooses "no preference," the patient is given information about the clinical trial. If the patient agrees to participate in the trial, the EHR system randomly assigns the patient to one of the two treatment options.

The physician then uses the EHR to record the patient's clinical data during the treatment course. Researchers can use the EHR system to track which treatment is associated with the best patient outcomes.

Advantages of Point-of-Care Trials

Researchers say point-of-care trials offer some benefits over traditional clinical trials because they:

• Allow researchers to quickly compare treatments for a specific patient population;
• Enable doctors to immediately implement more effective treatment regimens; and
• Eliminate delays involved in the peer-review process.

Louis Fiore, lead author of the Clinical Trials article, said the pilot project "has been successful so far, and we plan on rolling it out to other VA hospitals nationwide over the coming months" (Mansell, Pharma Times, 4/12).

A bit more detail from Stanford:

Meanwhile, the EMR software is tracking which of the two approaches is associated with the best outcome — in this case, “best” means getting out of the hospital quicker. As the study progresses and new batches of patients enter the trial, the software will preferentially direct more patients to the treatment that’s most successful at that time. The process continues with new batches until the estimated probability that one treatment is better than the other exceeds 99 percent.

An important advantage of a point-of-care clinical trial is that it allows researchers to quickly compare treatments on a local patient population, then immediately implement the best alternative into the physician ordering system of a clinic. That means no delays for peer-review or physician adoption. In addition, resulting decisions are tailored to specific populations, which can vary widely in their genetic, geographical and socioeconomic compositions. [...]

Traditional randomized clinical trials — considered the “gold standard” for the regulatory approval of drugs, devices and surgical interventions, as well as comparisons of approved treatments — remove this potential bias by randomly assigning treatments to patients. While this method produces highly reliable evidence, a large trial can cost many millions of dollars and can take a decade or more to complete.

A point-of-care trial — once integrated into a clinic’s informatics system — can be conducted relatively quickly, for very little incremental cost. Such trials won’t work for studies that need a control group or involve a new drug yet to be approved by the FDA, because neither is part of regular care. Still, point-of-care trials are useful for comparing efficacy of commonly used drugs, devices, treatments and interventions in which peer-reviewed evidence is lacking or inconclusive.

 

[SusanChase]

The article provides a roadmap for carrying out a point-of-care clinical trial comparing two standard methods of treating hospitalized patients for diabetes: sliding-scale insulin and the weight-based regimen. In the sliding-scale regimen, short-acting insulin is given three to four times a day as directed by an algorithm that factors in blood sugar levels, planned activities and sugar consumption.