SPECIAL SECTION: EHR CONVERSION

Striking Gold: Mining Data for Clinical Research with EHR

A California practice gives a first-hand account of the pros and cons of going digital to track trials.

BY Uyen Tran, BA , Edwin F. Archbold, PhD, MA , AND Michael K. Tran, MD, FACS

Clinical research is essential to improving healthcare for people all over the world. For a private practice physician, involvement in clinical trials provides intellectual and financial rewards, and adds a unique level of academia and cutting edge research to the practice. But along with these rewards are the challenges of integrating the extensive logistical and documentation requirements of clinical research and Good Clinical Practices (GCP) into the daily work of a medical office. Conducting a successful clinical trial not only means having an adequate pool of potential research subjects in your patient base and the staff expertise to implement the study protocol; it also requires having the right office clinic infrastructure.

With government incentives spurring more physicians to convert from paper charts to EHR, office clinic infrastructure is widely changing on a fundamental level. If clinical research is already part of one’s practice or is at least on the horizon, it is crucial to consider the pros and cons of adopting EHR — and what kind of EHR — in one’s office clinic. Recently, our office conducted our first clinical trial after implementing an EHR. This article summarizes our experience, from the points of view of a study coordinator, research monitor and principal investigator.

Screening Patient Samples

One of the greatest advantages afforded by EHRs is the ability to “data mine.” The work of pre-screening patients to find those who pass the inclusion and exclusion criteria of a clinical study protocol is often tedious, laborious and time consuming when dealing with paper records. When a practice has a large pool of patients, conducting pre-screening involves gathering all the paper charts and combing through thousands — or hundreds of thousands — of sometimes illegible or cryptic notes. While this is being done, the paper charts are not accessible to other staff with essential functions in the regular practice, such as billers or surgery schedulers.

With the right EHR, it is quite easy to set up search criteria to find patients with specific diagnoses, ages, medication history and other characteristics. Once identified, the research coordinator can look at their electronic charts to fine-tune the selection process. This can be done without physically having to possess their charts and limiting access to them by other staff. Once the pool of patients is narrowed, a list can be generated and the study coordinator can start calling to recruit potential subjects. Mail merge letters and address labels can also be made to facilitate communication. Since most research studies have “competitive enrollment,” whereby each clinical research site competes with the others to enroll the combined number of subjects called for by the study protocol, EHR gives a distinct advantage by allowing quick identification of potential enrollees.

In our study, we were able to identify patients with the specific condition being studied very quickly, and the study coordinator was able to devote her time to calling potential subjects rather than identifying them via paper charts review. However, we found that most of the patients who eventually enrolled in the study did not come from these calls, but rather were patients who had regular medical appointments and were recruited by the principal investigator during their visits. This is reflective of the importance patients place on the opinion of their doctor in deciding whether they should participate in a research study with inherent unknown risks. This tendency, however, does not diminish the data mining advantage that EHR offers.

For a study in which the condition of focus is less prevalent, waiting for the rare patients to come through the office for routine office exams would not be an efficient way to identify potential subjects. Another benefit from EHR that emerged in our study was that our screen failure rate was very low. This is due in large part to the ease with which patient clinical data can be quickly and accurately accessed in order to determine inclusion and exclusion criteria qualifications.

Not Exactly Paperless

Where EHR does not live up to its billing, however, is in the area of “going paperless,” at least when it comes to clinical research. In a clinical trial, the data called for by the protocol is recorded in a “source document.” Traditionally, the source document is a paper chart that has several essential features. First, it allows recording of data that often may not be captured in the regular clinic chart. Second, to facilitate data entry, the formatting of the source document often mimics the formatting of the Electronic Data Capture (EDC) tool, usually a Web site to which the data is transferred and then transmitted to the research sponsor. Third, the source document has to allow the FDA to audit when and who entered and/or altered data.

According to the FDA, “Verification of source data is necessary to confirm, amongst other things, the participation of subjects and to detect omissions, transcription errors, alterations in data, or falsification of data. When paper source documents are available for review, tracing of data in paper-based studies can be performed easily. However, when source data are electronic, the data are traced through complex data capture, transmission and archival processes.”¹

The Code of Federal Regulations Title 21 Part 11 specifies the FDA criteria under which electronic records and electronic signatures can be considered trustworthy of use in clinical research. If EHR is to replace paper source documents, what does it take for the EHR system to be Part 11 compliant? Do clinical research staff and the Study Monitor (a representative for the study sponsor who is responsible for overseeing the conduct of the clinical trial at an office) have a unique username and password to access the EHR system, using clearly defined user roles and/or privileges and audit trail protection capabilities on the system? Is the audit trail protected from modification by system users? Does the EHR have the ability to perform manual and/or automated back-ups of study data in regular fashion? Lastly, what are the implications of the Study Monitor having unrestricted access to charts in the EHR system, including those of patients not involved in the study?

Because of software limitations and FDA requirements, most EHRs currently available cannot function as source documents. They often come with pre-programmed data fields for routine clinical practice, and new ones required by the research protocol might not be able to be added. The way data fields are arranged on the screen also may not be customizable in order to match the EDC tool. Last, while EHRs are required to have some ability to be audited in order to qualify for financial incentives, the requirements are not as stringent as those imposed by the FDA for clinical research.

At our office clinic, we use an EHR system that has the capability to be customized to function as a source document with all the features outlined above, but in the end we decided to use traditional paper source documents. From a practical standpoint, it was easier for us to print and certify the patient’s medical history from the EHR, and to record study data on a traditional paper source document. For this particular study protocol, we also felt that using our EHR for the source documents would have made monitoring activities more complex.

Conclusion

As the tradition of documenting medical information moves from paper charts to electronic charts, requirements from sponsor companies and the Food and Drug Administration are also evolving to ensure good clinical practices with regard to clinical research. If clinical trials are in one’s future, carefully consider how an adopted EHR will affect the conduct of these trials.

From our experience, we recommend choosing an EHR that allows for “data mining” and can be customized to incorporate new data fields and formatting. It is also important to evaluate EHR systems based on the full range of technical specifications including their back-up frequency capabilities and user privilege options. Anticipate how well the EHR system deals with audit trail protection and source documentation maintenance, keeping an eye toward the need of future system upgrades and long-term storage requirements. OM

References

1. Guidance for industry: Electronic Source Documentation in Clinical Investigations. (12/2010). Food and Drug Administration Web site. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM239052.pdf. Accessed January 2012.