Can e-integration speed drug development?
By Robert Barr
The current U.S. economic recession has caused the growth rate to skid within the healthcare IT sector to a low 2.6%, amounting to a projected $28.4 billion in 2009, according to Gartner, Inc. Fortunately, this dreary outlook isn’t expected to last long, as the research firm anticipates that spending will resume its peak rate of 6.6% by 2011. This speedy recovery is in large part due to President Barack Obama’s pledge to bring change to an aging healthcare industry. The Obama administration has already committed to providing $50 billion over five years toward the advancement of healthcare IT, specifically, to drive the widespread adoption of electronic health records (EHR).
Historically, patient record-keeping has been a manual, laborious, paper-based process.Most records are often “physical” media such as film (x-rays), paper (notes), or photographs, making the storage and sharing of these records problematic. EHR, which refers to an individual patient’s medical health record in a digital format, was developed to streamline the storage and retrieval of these records. The benefits exceed time and cost savings, as the widespread adoption of EHRs will result in a standardization of forms, terminology and abbreviations, easing billing, improving data input accuracy, and most importantly, increasing the quality of care for patients. Yet, despite the overwhelming benefits, only 17% of the nation’s healthcare facilities, such as hospitals, clinics and private physicians, currently use some form of EHR.
One of President Obama’s top priorities this term is to devise an achievable timeline toward digitizing all medical health records within five years. “To improve the quality of our healthcare while lowering its costs, we will make the immediate investments necessary to ensure that within five years, all of America's medical records are computerized,” the president said in a speech at George Mason University in Fairfax, VA. “This will cut waste, eliminate red tape and reduce the need to repeat expensive medical tests. But it won’t just save billions of dollars and thousands of jobs; it will save lives by reducing the deadly but preventable medical errors that pervade our healthcare system.”
In conjunction, President Obama has also taken drastic measures to reduce drug costs with budget provisions for possible re-importation of less expensive medications and cuts in payments to private insurers and drug manufacturers. These changes have put additional pressure on the pharmaceutical industry to find ways to both reduce costs and accelerate the time to market for drug development. One significant step toward alleviating some of the pressure from the pharmaceutical industry has been the integration of electronic data capture (EDC). Currently used in more than 40% of all clinical trials, EDC is a method for collecting clinical data in electronic format. EDC significantly decreases the time to collect, manage and analyze clinical trials results, thereby reducing the time that it takes for new, life-saving drugs to get to market.
As the demand for both EHR and EDC surges, industry leaders recognize EHR-EDC integration as the next beneficial undertaking. While most recognize that EHR vendors, healthcare providers, EDC vendors and pharmaceutical companies all stand to gain, it is the pharmaceutical industry that stands to benefit the most, and that industry must take the reins in driving EHR-EDC integration into the larger market. It is imperative that the pharmaceutical industry takes the necessary steps to ensure that regulatory requirements, standards, technologies and other participants are all stepping in sync.
Healthcare and pharmaceutical industries have separate regulatory requirements in place that must be followed to ensure systems are validated. These regulations protect the integrity of the data within these systems, as well as the privacy rights of patients. Since requirements differ from industry to industry, when integrated, it becomes difficult to determine where one regulatory path ends and another begins.
In order for a data merge to be successful, both the EHR system and the EDC system must completely understand the requirements of the other to ensure that the data meets all regulations, particularly in situations where applicable data may exist between the two systems. For example, patient data that has been entered into the EHR system is subject to the healthcare industry’s rules, such as Health Insurance Portability and Accountability Act (HIPAA) related to patient privacy and security. During the integration process, some of this data may be transmitted from the EHR system to the EDC system, which is then subject to medical research rules, such as 21 Code of Federal Regulations (CFR) Part 11 related to data integrity, validation and security.
Currently, the task of unifying regulatory requirements remains within the healthcare and pharmaceutical industries, respectively. Both parties are working internally to define how the chain of custody is controlled and at what point each system’s rules should come in to affect. The healthcare and pharmaceutical industries are united, however, in their dedication to maintaining patient privacy throughout the entire data exchange process.
While separate standards exist within each industry, both sides have dedicated enormous amounts of time and resources toward adjusting their respective standards to extend support to the other side. In some cases, major transformations have taken place to provide a mapping to standards on both sides, allowing a controlled and well-documented way of exchanging data between the two systems. Industry organizations, such as Integrating the Healthcare Enterprise (IHE), the Society for Clinical Data Management (SCDM) and the Clinical Data Interchange Standards Consortium (CDISC), have come together, along with leaders within both industries, to define and document standards that can be used to share data.
IHE is an organization driven by healthcare professionals and the industry to improve the way computer systems in healthcare share information. IHE played a key role in developing the Continuity of Care Document (CCD), an XML-based markup standard intended to specify the encoding, structure and semantics of a patient summary (including patient demographics, medications and allergies) for seamless exchange between healthcare and pharmaceutical systems.
On the pharmaceutical side, CDISC has worked toward developing standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. CDISC is well-known for developing the Clinical Data Acquisition Standards Harmonization (CDASH) standard, which focuses on streamlining data collection in a way that promotes improved data interoperability throughout the biomedical research and product development processes, and enhances the interface with healthcare and EHR.
IHE and CDISC have jointly supported the development of an EDC data entry screen that can be pre-populated with routine patient information (demographics and patient histories) from within a standard EHR environment.One outcome of this has been IHE’s Retrieve Form for Data Capture (RFD), an integration profile which addresses the problem of integrated data capture for patient care and clinical research. This has been particularly essential in integration efforts because RFD enables EHR applications to directly request forms from clinical trial sponsors and public health reporting.It also enables pharmaceutical R&D teams to potentially shorten the timeline and cost for initiating new studies by creating an enormous pool of potential participants, should clinical trial organizers be able to tap EHRs within medical and healthcare facilities. This would, in turn, remove the need for source data verification, eliminating costs associated with study monitor visits.
With regulatory requirements and standards starting to fall in place, the burden for ensuring that EHR-EDC integration comes full-circle is now with technology vendors. Leading vendors from both sides have already begun to take steps toward preparing their technology for integration. However, the road has been a rocky one, requiring the integration of complex protocols and standards, elimination of cross-platform requirements, and participation in interoperability demonstrations and pilot-studies to proactively remove significant integration barriers.
Working closely with organizations such as IHE and CDISC, a handful of vendors have been in step from the start. Early on, these vendors were able to provide insight and feedback into the initial development and participate firsthand in implementation. With the XML standards in place, vendors are now able to communicate between EHR and EDC systems. Additionally, they have created mappings to transform healthcare standard formats, such as CCD, into pharmaceutical formats, such as CDASH. This ability allows both systems to continue functioning without major internal modifications, only requiring that external wrapper software be written to communicate and transform the data between systems.
With the use of XML and web services, EHR-EDC integration has become platform independent. This means that limitations that may plague other integrations are no longer an issue. Vendors running completely different technologies are now able to integrate their systems into RFD by following pre-set standards. By enhancing systems to support the RFD interface, there are no limitations on the type of hardware or software being used. This represents a significant cost-savings benefit to both industries, because it enables existing systems, both new and old, to work together in this integration process.
Progressive vendors are already participating in interoperability demonstrations and pilot studies. At the 10th Annual IHE North America Connectathon, attendees were shown an integration demonstration between clinical trials’ EDC technology and EHR used within healthcare systems. By participating, vendors were able to prove their products’ interoperability and compliance with standards, including CCD and CDASH, and remove significant integration barriers that would otherwise have to be dealt with on site (at the users expense). A similar demonstration to one that was held at the HIMSS09 Annual Conference & Exhibition in April is slated to take place at the upcoming Drug Information association conference in June 21-25, 2009 in San Diego, where CDISC has invited vendors to demonstrate their product's RFD interoperability.
Outside of conferences, individual vendors have also begun to initiate pilot studies that demonstrate an EHR system’s ability to integrate with an EDC system, and vice versa, all in an effort to ensure that regulatory requirements, standards and technologies have been addressed accurately. A clinical research software and services provider and an ambulatory healthcare business solutions provider are currently collaborating on the industry’s first six-site pilot study aimed at proving the viability of shared patient data pulled from disparate platforms. This pilot study, involving test sites across the U.S., is the first time outside of staged, high profile interoperability demonstrations where realtime, live patient data is collected and shared by two separate data management platforms. Thanks to advancements in data standards through proponent organizations such as CDISC and IHE, the pilot study is utilizing RFD technical specifications. This enables both organizations to access patient data within their native applications without duplicate data entry or additional paperwork.
“The ability to effectively reap the benefits of information that could be extracted from available data has been somewhat limited, due to an inability to effectively access isolated data silos, whether they be electronic or paper,” said Alan Louie, Ph.D., research director for IDC’s Health Industry Insights. “Integration is key to overcoming these hurdles and beginning to open the floodgates to both improving clinical trial operational efficiencies and delivering better medical decision-making at the point of care.”
In truth, all participants stand to gain from EHR-EDC integration. The benefits to the healthcare industry will be seen in physicians’ ability to provide a better continuum of care for patients. Giving physicians direct access to clinical trials inclusion criteria increases their ability to identify and enroll applicable patients into active studies while significantly decreasing their data entry demands. Similarly, the benefit to patients will be the increase in opportunities to participate in leading research for their diseases. After all, more efficient clinical studies will shorten the time that it takes for new, life-saving drugs to get to market and ultimately, into the hands of the patients that need them.
Yet while EHR-EDC integration would undeniably benefit all participants, the pharmaceutical industry, by far, stands to gain the most. To start, integration would be the resolution of two of the pharmaceutical industry’s most pressing problems: patient recruitment and randomization at the initiation of clinical trials. By integrating EDC with EHR, researchers will obtain a more efficient, more readily available solution for identifying and enrolling patients in new trials. For example, Case Report Forms (CRFs), which are paper or electronic questionnaires specifically used to document data on each patient participating in a clinical trial (including adverse events), can be pre-populated with data coming directly from existing electronic health records at diverse sites.This increases performance and efficiency of data capture while also minimizing the potential for bad data related to re-entry into multiple systems. This type of environment will also enable sponsors to test hypothetical enrollment trends and spot recruitment problems even before the study protocol is finalized — saving the pharmaceutical industry a significant amount of time, money and resources.
While the overall industry is still mid-shift toward EHR-EDC integration and is currently in the testing and implementation phase, the benefits for patients, physicians and those within the pharmaceutical industry are becoming obvious. With the emerging support of the Obama administration, the future of integration is bigger and brighter than most anticipated. Healthcare and pharmaceutical industries are only one small piece of a greater project being supported by IHE and CDISC. The ability to exchange secure and reliable medical health data is bringing together many different pieces of the puzzle, such as medical imaging, medical hardware and devices, laboratories, accounting and many more. It won’t be long until all participants come together in sync towards a common goal: streamlining data processes to save time, labor, costs and most importantly, patients’ lives.