Lee Shapiro, Allscripts, LLC USA

If we are serious about reducing healthcare costs, we must realize the important role that pharmaceutical care plays in the cost equation. Overall, our health system spends pennies for pills, compared to thousands of dollars for procedures. Yet delays in bringing new medications to market cost our healthcare system billions of dollars each year (not to mention lost revenues for pharmaceutical companies). Meanwhile, patients are waiting for treatments that could enhance or extend their lives, in many cases at a cost less than currently available treatments. 

This article focuses on one narrow aspect of that problem — enhancing speed to market by accelerating clinical research. According to the Center for Information and Study on Clinical Research Participation, nearly 80% of all clinical trials in the U.S. are delayed by one month or more because of unfulfilled enrollment of patients into trials. One way to make the process quicker is to enlist the assistance of physicians by enhancing their knowledge of available clinical trials and engaging with their patients to participate. 

The problem is that interested physician practices face the need to install and learn two separate IT systems for which there is, as yet, no standard linkage: the electronic health record (EHR), which experienced physicians say can augment clinical trials, and electronic data capture (EDC), used by pharmaceutical companies and clinical research organizations (CROs) to collect information. Why not merge the two, many in healthcare are asking? A single, integrated system could not only facilitate faster development of life-saving drugs but significantly enhance patient safety by reducing preventable medication errors, which injure 1.5 million Americans each year and kill nearly 7,000 — one major benefit of EHRs. 

It’s not that the industry isn’t working on EHR-EDC interoperability. In 2008, the Clinical Data Interchange Standards Consortium (CDISC) released a first draft of guidance for the use of EHRs in clinical research, following up on the earlier introduction by FDA of 21 CFR Part 11 rules for the same purpose. And at HIMSS 2009, the world’s largest healthcare IT trade show, a coalition of industry vendors, including my company, Allscripts, demonstrated the real-time sharing of information between the two systems. But there’s no question that progress has been slow. 

Several developments are now speeding things up. 

	The American Recovery and Reinvention Act (ARRA) of 2009, which will provide $44,000-$64,000 in stimulus dollars for practices that implement an EHR between 2011 and 2016, is accelerating the pace of EHR adoption. The Congressional Budget Office estimates that 90% of practices will be using an EHR system by 2019. One reason this is so important is, again, patient safety: Paper records, often written in illegible handwriting, are a primary cause of preventable errors, and EHRs connect physicians with critical clinical information in real time, which promises to limit duplicate costs and prevent many medical errors.

Some pharmaceutical researchers have viewed EHR data as less scientifically “pure” than data from EDC systems because they believe it is collected in a less controlled manner. But this perception is rapidly changing as researchers become more familiar with EHR technology, which, in reality, is every bit as reliable as data collected for clinical trials in EDC systems. In general, the same people who collect data on research patients also document care in their clinical practices. Furthermore, the threat of malpractice litigation is a strong driver of high quality documentation among physicians. 

Another hurdle to EHR use in data capture for clinical trials is the lack of a certification program to definitively demonstrate that a system is compliant with those 21 CFR Part II rules. Ultimately, guidelines for clinical research should be developed and incorporated by the Certification Commission for Healthcare Information Technology (CCHIT), the main certifying body for EHRs, but this notion is still at a very early stage. 

In this ongoing debate, too many people are focusing on the challenges without considering the promise. We need look no further than the banking industry for a real-life example of the benefits of connectivity. Banking is a highly competitive industry with differing information standards, technologies, and authentication methods, all dealing with the only thing requiring as much care as your health — your money. Yet the banking industry early on discovered how to use technology to seamlessly deliver “just right, just in time” information via the automated teller machine (ATM). Today, anyone with a bank account can use an ATM anywhere in the world to access money across continents in seconds. If the banking industry can do it, then surely healthcare can. 

In addition to enhancing patient safety, leveraging the EHR for clinical research would provide numerous benefits for all parties, among them the ability to: 

Provide near real-time feasibility testing of clinical trial protocols 

Speed identification of patient candidates

Reduce the failure rate of initial patient screenings

Provide enhanced protections for patients 

Reduce risks for pharmaceutical companies.

	Allscripts is helping physician practices optimize their participation in clinical trials in several ways: 

Allscripts Electronic Health Records are currently used by 60,000 physicians to automate and connect different aspects of patient care. Physicians rely on it to connect them in real time to the information they need from diverse stakeholders, including pharmacies, payers, patients, laboratories, hospitals, and other physicians. To manage their participation in clinical trials, many practices use Study Manager (a product of Study Manager, Inc., of Seattle, WA), a Windows-based, web-enabled application that is the most widely used clinical trial management system. Study Manager, which tracks a practice’s progress against milestones and manages their recruitment process and research budgets, is provided in an EHR-integrated form exclusively by Allscripts.

The Allscripts Clinical Trial Network (ACTioN) is a matching service with supporting resources that leverages Allscripts EHR to connect practices and patients to research opportunities. Currently, 500 principal investigators and 16,000 physicians who use our EHR system are now using the network to either recruit patients for clinical trials or find the right trial for their patients. Pharmaceutical companies and CROs can use the aggregated, anonymous patient profiles derived from combined medical records in ACTioN to find those practices with patients that fit the exact protocol for any given clinical trial — and they can do so without compromising the privacy or security of the patients’ information. 

RecruitAssist is a Web-based feasibility and site optimization tool, provided at no cost to ACTioN sites, that is used to input inclusion and exclusion criteria and determine how many patients might be eligible for a study. Once a study is started, it can also be used to generate patient recruitment lists, accelerating what can be a lengthy process in offices that rely on paper-based recruitment efforts. 

RecruitAssist also enables pharmaceutical companies and CROs to access aggregate ACTioN data, allowing them (1) to adjust trial protocols in advance to better align with the realities of actual patient populations; and (2) to locate research-experienced practices that already have trusted relationships with appropriate patient populations. One company that was hoping to recruit two or three candidates a year for a study on insulin inhalers was able to find 30 prospects within minutes; in a matter of weeks, a large multi-specialty physician group in Washington, DC had successfully recruited four candidates for the study. 

A good example of how ACTioN and RecruitAssist work together is provided by Northeast Georgia Diagnostic Clinic (NGDC; Gainesville, GA), which has 32 physicians and 30,000 active patients, and has been using Allscripts EHR since 2005. In 2008 the clinic created the NGDC Research Center as a full-service, multi-specialty, private practice-based investigative site. NGDC Research Center was an early member of ACTioN, participating in monthly ACTioN Forum calls on topics such as educational opportunities to pursue as a new research site and ways to identify potential research projects. With the help of a consultant (hired based on the advice of the Allscripts clinical trials team), the clinic built a detailed research plan and was soon ready to market itself to pharmaceutical companies and CROs, which it did using RecruitAssist. 

In fairly short order, NGDC Research Center was approached by the Allscripts team with a research opportunity, including a study description and an estimate of how many eligible subjects there were in the site’s patient database. The subject was Paget’s disease, a rare condition that would have made recruiting participants a daunting prospect without use of the automated methods offered by RecruitAssist. The Center was interested. After completing the sponsor’s credentialing process, it signed its first contract with a major company — six months after start-up. 

Starting early this year, the research industry will also benefit from two new ways physicians will be able to use RecruitAssist to enhance their ability to conduct research: 

To benchmark their practice in terms of cost-effectiveness with similar sized practices in the area and identify areas for improvement. 

To deliver automated “meaningful use” reporting required by ARRA in order to qualify for EHR stimulus dollars. Allscripts will use its centralized data warehouse infrastructure to provide meaningful-use reports to physicians for review and, upon approval, will forward them to the Centers for Medicare & Medicaid Services. 

	Another tool coming in 2010 is Allscripts Physician Alerts, which will enable physicians using an Allscripts EHR to inform a patient of the availability of a clinical trial, in real time at the point of care. 

In collaboration with several major pharmaceutical companies and CROs, Allscripts has also created the Medication Compliance Index, which provides physicians using the company’s EHR with a patient’s likely medication adherence level at the time of prescribing. When fully activated, this will allow physicians to spend more time, as needed, to educate patients on the spot, ultimately promoting better outcomes by boosting compliance — and making it easier for pharmaceutical companies to demonstrate their products’ effectiveness. 

All these tools have been developed with sensitivity to the need to preserve the anonymity of patient information as mandated by HIPAA. Allscripts never reaches out directly to a patient or exposes personal health data; the relationship is strictly with the practice. 

Taken together, these and other developments on the horizon can be expected to significantly advance the country’s research agenda. Again, they will allow pharmaceutical companies to rapidly design and test clinical trial protocols based on real-world populations, and improve the yield of viable candidates by selecting research sites based on the number of patients that meet a given protocol; they will provide physicians with access to information regarding potentially life-saving new therapies during patient encounters. 

At the global level, these advances will likely revolutionize adverse drug-event monitoring. Allscripts EHR lets physicians report adverse events in the patient record; eventually, they will provide this information without compromising HIPAA to the FDA and other interested parties. 

At some point, clinical trials will become a seamless part of the services offered by physician practices. That day is getting closer. PC 

	Lee Shapiro is President of Allscripts, the leading U.S. provider of clinical software, connectivity, and information solutions for physicians. Shapiro directs the company’s strategy, business development and partnerships, and business activities addressing Allscripts electronic prescribing, revenue cycle management, emergency department information systems, care management and Internet-based consumer health services. 

Articles

Converging the processes and data from EHRs and from the electronic data-capture (EDC) of the clinical research environment could change the paradigm of drug development and safety