Translational Medicine and Biomedical Informatics Explained

Introduction to Translational Medicine

Translational medicine is a new discipline covering studies in basic science, human investigations, non-human investigations, and translational research (Mankoff et al., 2004). Basic science studies address the biological effects of medicines on human beings. Studies on humans discover the biology of disease and serve as a foundation for developing therapies. Non-human, or non-clinical, studies advance therapies for clinical use or use in human disease. Translational research refers to appropriate product development for clinical use and looks into the identity, purity, and potency of a drug product during early clinical trials (Mankoff et al., 2004).

Translating the knowledge derived from basic sciences into clinical research and treatments is the central task of translational medicine (Nagappa, 2006). There is a pressing need for this type of research given the enormous volume of information generated in the information age. Using this information effectively is the challenge encountered by scientists and healthcare providers worldwide. Clinical research has exposed this limitation in current clinical practice, and this recognition led to the development of translational medicine as a distinct discipline (Nagappa, 2006).

Translational research connects basic research to its application in the clinical setting (Mariani, 2003). The clinical setting encompasses the diagnosis, treatment, and prevention of disease — applying a discovery to practice. Edward Jenner is credited with the first clinical experiments in developing a smallpox vaccine, conducted in 1830 (Mariani, 2003).

Translational Research

A recent survey conducted by the Science Affairs Committee revealed that roughly 1,888 MD/PhDs; 3,194 MDs; 5,703 PhDs; and 480 other qualified professionals — a total of more than 11,000 researchers — are engaged in basic and clinical oncology research alone in the United States (Mariani, 2003). Developing new therapeutic strategies is a lengthy process. The research and development phase takes, on average, one to three years; clinical trials take two to ten years; and filings and approvals take two months to three years. In total, it takes three to sixteen years to introduce a new treatment into clinical practice in the United States (Mariani, 2003).

Teamwork is essential in every phase of this process (Mariani, 2003). This spans discovery, transfer to the clinic, evaluation of patient samples, and rethinking of treatment and delivery. A team may be far more effective under the leadership of a scientifically trained and experienced physician, as this setup enables the right questions to be raised when designing experimental standards and helps avoid dead-ends. Other factors that enhance successful translational research include the availability of mentors, time, rewards, and sufficient resources. Factors that deter or inhibit research success include distractions from other official duties, inadequate funding, differences in knowledge among researchers, technology transfer barriers, and strict scheduling constraints (Mariani, 2003).

Ultimate success, however, rests on high professional standards among those involved. This is a significant problem at present, as there is a shortage of trained medical personnel in the United States and in other countries conducting such research. Physician-scientists are particularly scarce in the fields of radiology, pathology, and surgery — the very professionals who can effectively communicate with clinicians. As a result, there is a wide gap between physicians who understand the problems and scientists who know the solutions. The chronic and global shortage of nurses further aggravates the situation. These circumstances may indicate a lack of appropriate education and rewards for high-performing professionals who uphold high ethical standards, as well as a lack of adequate resources and processes to ensure accurate and reliable assessments of new treatment strategies (Mariani, 2003).

Translational Medicine and Drug Development

Translational medicine is that branch of medical research which endeavors to directly connect basic research to patient care (Nagappa, 2006). It translates basic research into real therapies for real patients. The bench-to-bedside concept links laboratory findings to the patient's bedside for treatment. Many pharmaceutical companies have formed dedicated groups to facilitate this interaction. In the past, significant obstacles stood between basic research and clinical practice: new drugs were developed separately from the clinic and then submitted for safety testing and the necessary clinical trials. Translational medicine aims at eliminating the gap between them — hence the laboratory "bench-to-bedside" concept (Nagappa, 2006).

Translational medicine is a special form of diagnostics that provides prognostic information about a patient's condition in a non-invasive manner that causes no discomfort. As a technology, it identifies future and probable problems that may surface during drug development and guides those processes accordingly (Nagappa, 2006). Theories evolved at the laboratory bench during pre-clinical experimentation are tested on patients, and the results are then taken back to the laboratory to refine biological principles relating to human disease (TCG, 2008).

Translational medicine is a mix of basic science and clinical research. This mix requires skills and resources that have traditionally been distinct and separate, which is why research institutes, university science departments, clinics, and hospitals cannot individually accomplish its goals. Organizations that do possess these resources often encounter internal, political, and organizational impediments to integrating their functions and departments. Translational medicine can operate effectively only in environments where experts work together and share information (TCG, 2008).