One of the challenges of getting new medications and treatments approved is pulling together the important clinical trials. A new shift does appear to be emerging that could make it easier to contact and select clinical trial patients -- thanks to electronic medical records (EMRs). But will these shifts be occurring in the very near future? It depends.
As a Wall Street Journal article points out this week, new approaches are being tried that can speed up the recruiting process and expand the reach for more potential patients -- especially from groups such as minorities that have been frequently underrepresented in studies.
The problem is, though, that many providers still lack the newer EMR databases that can be readily searched. This means many trial screeners are still using the tried-and-true method of just querying patients who come into a physician's office or a hospital to find the appropriate candidates. This can take months and years to complete.
But there are examples of where EMRs can provide results quickly. The Journal article uses the instance of Danville, Pa.-based Geisinger Health Plan, which is one of 600 medical centers around the world participating in a GlaxoSmithKline PLC-funded trial of a new drug which is aimed at lowering the risk of heart attacks and strokes in those with coronary heart disease.
Using its data base and EMRs, Geisinger was able to take just a few weeks to identify at least 5,300 patients who fit within study's scope. They all met at least 20 criteria for the trial. It ended up mailing letters mailed to 1,700 potential candidates, who were provided a number to call.
Eventually 500 patients said they were interested in the clinical trial, and 101 were enrolled, which was more than Geisinger's initial goal. So it was quick and efficient, but there was a drawback: reimbursement. Generally, trial sponsors pay recruiters after the patients are participating in a study.
Under the current system, the medical centers or organizations with the EMRs still would be responsible for costs such as database searches, mailings, and call centers.
But now is the time for a new mindset: as one Geisinger official suggests, maybe if fewer centers can enroll patients in less time, new products and treatments can get to the market even faster -- and at lower costs. Maybe now is the time to wrap our ideas around what EMRs can really do to change the trial recruitment process.
In addition, EMRs can be used by healthcare organizations or plans to attract individuals to clinical trials who normally would not have been approached under the older methods of recruitment.
At Kaiser Permanente of Northern California, for example, efforts are made to contact newly diagnosed patients with cancer -- as indicated in their EMRs -- earlier for participation in clinical trials. Patients can communicate earlier with their providers about how clinical trials could be incorporated into their treatment strategies.
So how close are EMRs to making in big difference in the clinical trial process? The potential is there, but without a clear-cut national strategy, it will take some larger leaps -- by providers, health plans and the healthcare and drug manufacturers -- to develop a new paradigm that includes greater reliance on EMRs. -- Jan