By James Rogers, CEO, Nextrials 

October 29, 2012 | Vendor Contributed Comment | 2012 has been a bumpy ride for pharmaceutical firms, exacerbated by a significant loss of revenue related to drug patent expirations. It’s been estimated that drugs scheduled to go off patent this year represent over $30 billion in sales—and include drugs such as Merck’s popular Singulair asthma/allergy treatment and Takeda’s Actos for Type 2 diabetes. As a result, pharma companies have committed as much as 18% of revenues toward research and development, trying to discover new ways to utilize existing drugs (thereby extending their patents) or to bring new drugs to market, all the while trying to trim costs. 

A wealth of new tools and technological advancements may be the answer for how researchers can do both: discover new, life-saving therapies more quickly while simultaneously cutting costs. One development that is generating a lot of industry buzz is the integration of electronic data capture (EDC) platforms, traditionally used to manage clinical trials, with those used within the health care industry to create and maintain electronic health records (EHR).  

An integrated EDC/EHR platform is of interest to many researchers today because they are already using an electronic data collection tool to help manage clinical trials. Since the collection methodologies for EHRs are similar, a single system could simultaneously be used for patient care and data in both the hospital/clinic and clinical trial settings.  

High profile, staged interoperability demonstrations through organizations such as HIMSS and IHE have shown the industry’s significant progress toward deployment of integrated platforms. Nextrials and its partner, Greenway Medical Technologies Inc., were the first in the industry to conduct a multi-site retrospective study where patients were enrolled in real-time and patient data was collected through a single interface. This pilot project proved that two major problems long associated with the concept of an integrated platform, duplicate data entry and workflow issues, had been successfully resolved. 

The industry should prepare to move beyond early adopters toward the more widespread usage of an integrated EDC/EHR platform. Here are four reasons why: 

Larger site and population pools. According to Synergyst Research, only 10 percent of licensed physicians participate in clinical trials due to time and staff constraints. An integrated EDC/EHR platform provides an easy entrance runway for smaller clinics that have never participated in drug research. Thanks to the federal government’s lucrative incentives, most of them have adopted EHRs…so an integrated EDC/EHR platform enables them to economically extend their practices into research. For researchers, this creates a greater pool of potential sites and patient participants, particularly since people living far from large medical centers (where research is routinely conducted) can now enroll in applicable studies through smaller, more localized clinics.  

The Nextrials/Greenway pilot involved research-naïve sites that reported after the study that the platform’s ease-of-use encouraged them to continue exploring participation in clinical trials. 

The Mayo Clinic, for example, is already successfully mining its EHR data to identify subjects for the thousands of clinical trials it conducts annually. By tapping its EHR database, the organization hopes to improve patient enrollment and lower rejection rates.  

Faster study starts. Fewer enrollment delays save time and money. An integrated EDC/EHR platform can pre-identify sites with appropriate patients and facilitate patient randomization. Instead of spending an enormous amount of time soliciting subjects for a narrowly-defined protocol, an integrated EDC/EHR platform enables study researchers to quickly sift through bigger patient populations—and, through online tools, redefine the protocol as needed to better match the study to the real-life patient population. 

Better data and lower study costs. Because 80-90 percent of the data is taken directly from a patient’s record, data collection is faster and source data verification is eliminated. As a result, study monitors and research associates do not need to travel to sites as often. 

Eliminate transcription errors and deliver enhanced data. By removing the potential for transcription errors, data quality is improved. Study-specific data requirements can be embedded as special tabs, and rules and alerts to ensure compliance can be implemented. Information that is not normally collected within a site’s EHR can also be recorded and stored via an integrated platform’s eCRFs (electronic Case Report Form); the data can be then displayed within the EHR interface.  

Researchers interested in seeing more validation of the benefits of an integrated EDC/EHR platform can attend one of the interoperability demonstrations at upcoming professional meetings and trade shows such as the HIMSS 13 Interoperability Showcase, being held March 4-6, 2013 in New Orleans.  

James Rogers is the co-founder and CEO of California-based Nextrials, Inc. He can be reached at jrogers@nextrials.com.