By Callum Bir, Director, Life Sciences, Oracle Asia Pacific
Dated: 5/1/2008
The research and clinical care process has fundamentally changed in recent years.
When it comes to drugs and therapeutic programs, one size no longer fits all and the traditional practice of reactive medicine with treatment selected by ‘trial and error’ will no longer suffice. Numerous factors have contributed to this phenomenon.
The population is aging rapidly and Asia has been singled out as the world’s most rapidly aging region. By 2050, Asia is expected to house almost two-thirds of the world’s population over 60 years of age.
To exacerbate the situation, the number of chronic diseases such as heart attack, stroke, diabetes, respiratory disease and cancer has grown significantly. The World Health Organization (WHO) projects that by 2015, more than 70% of the people who will die from such diseases will be from Asia Pacific. This amounts to 270 million deaths out of 388 million deaths globally.
In order to deliver effective treatment and high-quality care, the health sciences industry is beginning to recognize that research data from laboratories needs to be converted at a faster rate into clinical practice to diagnose and treat patients. The process of applying molecular insights from laboratory discovery to clinical care is known as translational medicine. This represents a paradigm shift in the biomedical research enterprise and is regarded as the future of healthcare.
Technology Facilitates and Accelerates Information Exchange
Traditionally, bench scientists, drug developers and clinical researchers have rarely shared insights, ideas and information. The onset of new age research methodologies requires these stakeholders to embrace the use of technology to reduce bottlenecks in the development of new drug treatments. This will result in significant benefits in the area of public health and for the entire healthcare industry.
The challenge for health sciences enterprises is to build an information technology (IT) support infrastructure to provide an environment for researchers, clinicians and drug developers with workflow that can continually change and evolve as researchers work with a mix of clinical science, molecular science and clinical practice. These stakeholders must also be able to share and seamlessly transfer large amounts of clinical, patient, genome, genetic, demographic and supply chain data from one point to another, and in a secure manner to ensure patient confidentiality. The databases also need to be updated in real time at the clinic so the information is returned in a timely manner back to the research bench for meaningful diagnostics and analyses.
There are several core technology concepts in translational, personalized and molecular medicine environments that will help health sciences enterprises select a suitable IT support infrastructure. These include:
Database
As the quantities of available biological, genetic and biomarker information, and the use of public data repositories increase, consistency in the information held in these databases is vital to allow full integration, exchange and comparison of their contents.
Data is held in various repositories – hospitals, clinics and total wellness centers. A robust, field proven database is critical to store all the data in a single repository to help information back and forth to the research bench and clinics. Moreover, data needs to be seamlessly integrated from diverse sources such as research institutes, hospitals, government agencies, pharmaceutical companies and healthcare providers, and likely all with disparate IT systems.
The key to translational and personalized medicine is collaboration between all these various sources. This exponentially grows biomedical information in terms of volume and complexity. A database solution that incorporates IT best practices, built on open standards, hot pluggable into heterogeneous systems is necessary to manage this collaboration.
Service Oriented Architecture
The lack of integration among legacy systems and applications points to a continued dependence on manual processes that can introduce high risk errors into critical medical data. In addition, the disparate systems can compromise the health sciences enterprise to follow through the research cycle seamlessly from bench to clinics.
However, health sciences enterprises need not worry about system rip and replace, but instead take a Service Oriented Architecture (SOA) approach that leverages existing IT investments, is standardized in its approach and is flexible enough to keep up with the changing needs of the industry. Through SOA, health sciences enterprises can build an infrastructure that responds quickly to new organizational challenges and delivers new dynamic applications.
Open Technology Standards and Interoperability
Today’s health sciences organizations seek technology solutions that enforce industry standards and best practices. They are realizing the importance of interoperability between clinical, administrative, and financial business processes. They are trying to alleviate the burdens of data fragmentation, redundant data entry, cumbersome administrative processes, and lack of collaboration or information sharing across organizational boundaries.
Business Intelligence
In an increasingly competitive marketplace where health sciences organizations are struggling to reign in costs, the ability to transform data into information that can facilitate varied decision-making processes is quickly becoming a business imperative.
Health sciences organizations can adopt business intelligence solutions that leverage a rich data repository to deliver timely access to relevant, high-quality patient data - from patient conditions, treatments to outcomes – that are achieved regardless of where the patient data is created or stored. This means that information exchange can be delivered in real time from the bedside to the benchside and vice versa, allowing patients to benefit more quickly from cutting-edge research. At the same time, researchers get invaluable clinical data to support, clarify and refine further research.
Identity and Access Management
Security has emerged as a global concern. In the US, for example, the Health Insurance Portability and Accountability Act (HIPAA) sets requirements and regulations concerning access to and storage, usage, and transmittal of patient data, affecting most health insurers, pharmacies, hospitals and doctors.
These “covered entities” also typically include scientists conducting biomedical research, which is why informed consent must be obtained when a patient enrolls in a research study. Similar privacy regulations will be enacted in increasing number of countries. As more and more patient information is digitized and shared across networks, the need to protect and manage confidential records and bioinformatics has become paramount.
Health sciences enterprises need to select technology vendors whose products are secure by design; not just retrofitted or bolted on as an after fact. They should allow for assignment of privacy labels and control access to data to enable a large group of user community without compromising on the integrity of the data. Ideally, the vendor should possess the ISO 15408 security evaluation at evaluation assurance level (EAL) 4, the industry’s most rigorous assessment for commercially viable software.
With increasing governance and compliance regulating the healthcare industry, health sciences enterprises can more easily meet compliance initiatives without adversely impacting the practice with security policies such as identity and access management in place.
Technology as a Pillar for Translating Research into Reality
Translational or personalized medicine research may be hot areas in the medical and healthcare industry at the moment but development is still in its infant stages.
In order to “fast forward” new age medical approaches to actual patient care enhancement and results, the industry requires world-class technology solutions that truly understand the needs of scientists, drug developers and clinical researchers. This in turn will truly enable the health sciences providers to translate research into real decisions that can impact patient care and help usher in a new era of healthcare.
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