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BioPharma: FDA Clinical Trials

HIT Perspectives Biopharma Insights – September 2015

FDA to Assess Role for EHRs in Clinical Trials

By Brian Bamberger Life Sciences Practice Lead

The Food and Drug Administration (FDA) is working to bring the world of clinical trials into the digital age. This will create an expanded role for electronic health records (EHRs), with the result of speeding the cycle of clinical research and regulatory submissions and ultimately helping bring medicines to market faster.

The FDA’s interest makes sense. It is one of a number of government agencies looking to streamline and computerize paper-based processes associated with medical care and research, such as clinical trials. Even though EHRs are not yet an integral part of the process, government officials believe clinical trials could benefit from leveraging the use of EHRs to:

* Eliminate duplication of data by capturing and transmitting electronic source data.

* Autopopulate the electronic study forms from EHRs.

* Reduce transcription errors and improve the quality of data.

* Encourage entering source data at the point of care.

* Facilitate remote monitoring of data to reduce the number of onsite visits by a regulated biopharmaceutical industry.

* Improve site monitoring to minimize the need for cross-referencing data in multiple sources.

* Make it easier for investigators to conduct clinical research.

* Facilitate the inspection and reconstruction of clinical investigations by FDA.

* Improve the standards-based technology solution to encourage widespread adoption.

Despite the promise of using EHRs for clinical research in regulatory submissions, there are unknowns to be addressed. What needs to be done to make this happen? Which barriers need to be overcome?

To help answer those questions, the FDA issued a Notice in the June 26 Federal Register soliciting stakeholder input concerning the benefits of EHRs to provide the necessary kinds of data for clinical trials, implementation challenges, gaps between these data that are regularly collected by EHRs for patient care compared with those required for clinical research and regulatory submissions, and regulatory obstacles.

In addition, the FDA asked for expressions of stakeholder interest in demonstration projects to test and evaluate how use of a single point, end-to-end EHR-to-electronic data capture (EDC) approach could be used to provide the specific kinds of data necessary for clinical trials. Demonstration projects are a well-known tool to assess the impacts, costs and benefits of technologies under specific scenarios and parameters.

One place to start would be for Risk Evaluation and Mitigation Strategies (REMS). The FDA requires the use of REMS to manage the risks of some drugs or biological products in order to ensure their benefits outweigh risks. However, REMS programs today are typically mired in paper forms, fax machines or – at best – website portals, which duplicate data recorded in EHRs.

The FDA and National Council for Prescription Drug Programs are both actively shepherding new transaction standards forward with the help of a few pharmaceutical companies. Since most REMS programs require information already recorded in the EHR, a set of EHR-based REMS transactions would increase accuracy of information and reduce physician burden involved in complying with REMS programs. Automation of REMS protocols will benefit those drugs for which approval may be delayed due to additional required safety studies. Other benefits of automation include opportunities to provide more data in REMS programs, increased accuracy of data, lower costs to submit and collect data and an improved audit trail throughout the process.

Point-of-Care Partners applauds the FDA’s interest in leveraging EHRs for clinical trials. We have extensive experience in piloting transactions for EHRs and using them to full advantage by pharmaceutical manufacturers. Call or drop us a line to discuss the possibilities.