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Clinical Trials and EHRs: Incentive to Integrate

Expert Comment: EHRs can save health care money, improve care, and facilitate research.

By Chris Thorman

May 18, 2010 | Clinical trials should play a much bigger role in the decision to purchase electronic health records (EHR) software. One incentive for practices is that participation in clinical trials has the potential to net a profit of hundreds of thousands of dollars per year. Using EHR data in clinical trials is a win for physicians, patients, the companies conducting clinical trials and the entire health care system.

While there are many factors that go into an EHR software purchase, clinical trial participation deserves more consideration because:

    * Participating in these trials is easier through an EHR than through traditional paper means;
    * Using EHR data solves many of the major problems that clinical trials face; and
    * Purchasing an EHR creates a big ROI for physicians who decide to participate in clinical trials.

EHR Software Facilitates Clinical
Trial Participation

According to Synergyst Research, only 10% of licensed physicians participate in clinical trials. Major reasons include the extra burden that research and information collection place on a practice’s time, staff and resources. Extra paperwork and onerous regulations are involved, not to mention training staff on how to properly complete forms and follow protocol. The average practice would find it difficult to find the resources to create a new department devoted to clinical trial participation.

Those using EHRs, however, stand a better chance of being able to adapt to the needs of a study. There are several that EHR software can make the clinical trial process faster, more efficient and more accurate:

    * Identify potential opportunities: EHR vendors whose software integrates with clinical trial providers will have access to trials, studies, and registries that your practice is eligible to participate in.
    * Identify number of potential trial subjects: The search function in an EHR database allows users to quickly identify how many patients are potentially eligible for a clinical trial. From there, the clinical trial provider can determine if a practice would be a good partner.
    * Patient enrollment: The EHR has the capability to implement trial-specific screening requirements into new patient records to determine their eligibility for a study. The EHR will also have the ability to identify patients who meet the exact requirements of a study.
    * Study execution: During the trial, the EHR can create trial-specific data fields that can be populated during routine patient encounters. Conflict alerts can also be created to notify providers of actions that violate a study’s protocol.
    * Data submission: The EHR will be able to submit information to EDC software without having to convert the data. This eliminates redundant data entry and increases accuracy of the data.

By using an EHR to do much of the patient identification and information collection, many of the previously mentioned obstacles no longer exist. If a practice purchases EHR software that doubles as an electronic data capture (EDC) system for clinical trials, then it is way ahead of the curve in terms of efficiency and accuracy.

Clinical Trials Are Important to the Future of Health Care

We all know the alarming cost and time required to bring a new drug to market, not to mention the 75% failure rate. This mediocre productivity leads to increased health care costs and patient suffering as drug approval is delayed. If clinical trials could be completed more quickly using EHR software, it wouldn’t just be drug companies that benefit. Sick patients waiting on essential treatment would be treated more quickly, health care costs would be reduced, and the conclusions reached from the data gathered would be more robust.

Get a Stronger Return on Your
EHR Investment

The chief areas of return on investment (ROI) on EHR purchase include: reducing the need for transcription services; improving insurance claim coding; reducing paper supply costs; and improving chart management.

These are all good, but we believe the profit from participating in clinical trials is just as great a benefit. For example, soon after the Holston Medical Group (HMG) in Kingsport, TN, began using an EHR in 1996, the company began participating in clinical trials using the data from their EHR. HMG’s EHR influenced their involvement in clinical trials in three major ways.

First, HMG is able to quickly query their EHR database to see which patients qualify for particular studies. Next, the scope of patient information contained within their EHRs helps improve accuracy when screening patients for clinical trials. Finally, HMG’s EHR is web-based, which means that its doctors always have access to the latest patient information, no matter where the doctor is located.

As clinical trials become more protracted and expensive every year, it’s inevitable that drug companies will turn to those organizations that can quickly and accurately assess patient data. More than likely, those organizations will be using EHR software.

Chris Thorman blogs about medical technology at Software Advice, a web site that reviews software for EHRs. This commentary is adapted from Chris’ blog: Electronic Health Records and Clinical Trials: An Incentive to Integrate.

This article also appeared in the May-June 2010 issue of Bio-IT World Magazine. Subscriptions are free for qualifying individuals. Apply today.



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