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Electronic Health Records and Clinical Trials: An Incentive to Integrate

By Chris Thorman

As we wait for the federal government to finalize important sections of the Health Information Technology for Economic and Clinical Health Act (HITECH), there is a lot of talk about the financial incentives for implementing electronic health records (EHR).  Practices that implement an EHR under the federal government’s guidelines stand to gain over $60,000 in incentives over the next five years.

A related topic that has not been as hotly discussed is using information gleaned from EHR software to participate in clinical trials.  Such information should play a larger role in deciding whether or not a practice should purchase EHR software. Why? Participation in clinical trials has the potential to net a profit of hundreds of thousands of dollars per year. Now that’s an incentive to purchase an EHR.

While there are many factors that go into an EHR software purchase, clinical trial participation should get 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.

Using EHR data in clinical trials is a win for physicians, patients, the companies conducting clinical trials and the entire healthcare system.  Here’s why clinical trials should be a factor in purchasing EHR software.

EHR Software Facilitates Clinical Trial Participation. According to Synergyst Research, only 10% of licensed physicians participate in clinical trials. Why is participation so low?

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 time and 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. See the enclosed table for ways that EHR software can make the clinical trial process faster, more efficient and more accurate.

STEPS IN THE CLINICAL TRIAL EHR SOFTWARE’S ROLE
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 a user to quickly identify how many of a practice’s 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’s way ahead of the curve in terms of efficiency and accuracy.

For years, there has been a growing push for EMR software to integrate with EDC systems. Greenway Medical Technologies is one company doing this through their PrimeResearch solution. In addition to designing their EHR software to natively submit data to EDC systems, Greenway is providing access to “a vast network of clinical studies, quality/safety initiatives, composite (clinical and financial) analytics that lead to more efficient processes, improved patient care and increased practice revenue.” Essentially, Greenway has created a turnkey solution to help practices participate in clinical trials.

Participating in a program like Greenway’s allows a practice to: Easily identify clinical trials that the practice may be eligible to participate in; quickly query their database to identify patients who meet certain conditions for participating in particular clinical trials; submit information from their EHR directly to EDC systems; and, reduce overall data entry time and costs associated with clinical trials.

By digitizing what used to be paper records, a practice can lower the number of patient rejections from a trial, decrease time spent doing data entry, reduce transcription costs and reduce staff time related to clinical trial participation.

Clinical Trials Are Important to the Future of Healthcare. Most drugs and treatments on the market today originated from some form of a clinical trial. These tests are extremely important to the health of virtually every person in the world. But unfortunately, getting a new drug to market costs more than $1 billion dollars; takes approximately 10 years; and has upwards of a 75% failure rate. This leads to increased healthcare costs and more patient suffering as drugs wait to get on the market.

If the clinical trials could be completed more quickly by using EHR software, it wouldn’t just be the drug companies that would benefit. Sick patients waiting on essential treatment would be cured more quickly; overall healthcare costs would be reduced; and the conclusions reached from the data gathered would be more solid.

Get a Stronger Return on Your EHR Investment.  When it comes to getting that return on investment (ROI) on your EHR purchase, the typical benefits discussed are: reducing the need for transcription services; improving insurance claim coding; reducing paper supply costs, and; improving chart management, to name just a few. While these are great reasons to purchase an EHR, the profit from participating in clinical trials is an equally important benefit.

Comprehensive data on how much a practice can profit from using their EHR in clinical trials is difficult to come by. But a compelling example is the Holston Medical Group (HMG) in Kingsport, TN. Soon after HMG began using an EHR in 1996, the company began participating in clinical trials using the data from their EHR. In the last few years, they created a strong ROI on their investment. Health Management Technology reported that “HMG’s income from clinical research went from $86,700 in the first year (1996) to $1.9 million in 2004, with estimated 2005 revenues of $2.5 million. That 68 percent average annual revenue increase enabled us to pay substantial bonuses to participating physicians—a total of $330,000 in 2004, with roughly $420,000 for 2005—and to cover the entire annual cost of operating the research department and the EHR itself.“

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. Instead of using traditional (and lengthy) screening procedures, HMG has the ability to almost instantly check their EHR records to see how many patients potentially qualify for which clinical trials.

Next, the scope of patient information contained within their EHRs helps improve accuracy when screening patients for clinical trials. The more information a practice has on a patient, the better able it is to assess a patient’s eligibility for a study. HMG’s EHR puts detailed information about their patients at their employees’ fingertips, which leads to increased enrollment and lower rejection rates.

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. The EHR will notify doctors that a patient is enrolled in a particular clinical trial, which allows them to double check that certain medications or treatments won’t violate the protocol of the trial.

Another example of an organization using EHR data to profit from clinical trials is the Mayo Clinic. The Mayo Clinic has 7 million digital patient records and they’ve teamed up with a firm to help unlock those records’ potential for accelerating clinical trials. The Mayo Clinic conducts thousands of clinical trials each year and they are paid based on the number of patients they enroll. Patient enrollment is one of the most difficult challenges in any clinical trial. Mayo is hoping that tapping its EHR database will improve patient enrollment and lower rejection rates.

Clinical trials are taking longer and becoming more expensive every year. As these trials become more cumbersome to conduct, 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.  Improving clinical trials by using EHR software is a win for everyone.

Chris Thorman is Senior Marketing Manager for Software Advice and can be reached at chris@softwareadvice.com.

2 comments

  1. Great article and useful information. While there are many factors that go into an EHR software purchase, we think clinical trial participation should get 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.

  2. Thanks for this article, Chris. I have been talking to several physicians about how I can be their sherpa as we navigate the clinical trial mountain but their initial interest nearly always leads to disbelief.

    NIDDM trials that pay $8,000 a patient, HTN trials paying $9,000 a patient, oncology trials paying $11,000 per patient… they are incredulous when they here this. Even screening failures get paid $400 – 600 dollars. These numbers aren’t common knowledge but they’re out there. Still, the I believe eventually some physicians will gamble, discover that one clinical trial can pay them $200,000 – 300,000 and word of mouth will get more physicians on board.

    After a decade in the industry, I am still stunned by the cash burn as pharmas enroll patients. It can take 12 – 24 months to get enough numbers for a phase 3 trial. The physician that uses EMR as a tool to identify candidates en masse, and then present that double digit number of pre-screened, protocol eligible, and willing patients will immediately find themselves a new best friend with deep pockets.

    Your EMR system will need to be robust and / or it will need to sit of a SAS platform so that customized extracts can be performed (How many post menopausal women are in my database who are on statin therapy, HRT, have a positive family history of cardiac disease but are not insulin resistant. Oh, they can not have ever been in a trial and can not be taking niacin supplements. This would be a valid query.)

    There are systems out there that can ginsu their way through a database and have an answer in less than a minute. Most will have to print out a few reports and staff will manually merge them together over the course of a few hours. Those with paper charts…

    A respectable EMR system, a happy EMR subject matter expert, a Study Coordinator and a clinical trial should gross about $200,000 per trial. With these numbers, your ROI for your EMR system should happen in months, not years.

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