Translational Research

Introduction

This chapter begins with a description of the evolution of the term “translational research.” Then, the authors describe the current state of translational research, reasons for the results of basic research not leading to good results in clinical research, and steps that should be taken by drug researchers to be successful.

Translational research has recently become popular, but it has not been clearly understood and there are many points that are unclear. The term translational research emerged from the field of cancer research in the 1990’s and has developed in various fields. The National Institutes of Health (NIH) launched the Clinical and Translational Science Award program in 2006 and has dedicated large sums of money to the development of translational research. Thus, translational research has become a national project. Furthermore, journals that focus on translational research, such as Nature Reviews Disease Primers, and Journal of Translational Research , have been launched.

Definition

Early in the first decade of 2000s, the definition of translational research was: “ Translational research transforms scientific discoveries arising from laboratory, clinical, or population studies into clinical applications to reduce cancer incidence, morbidity, and mortality ” ( Fig. 55.1 ). This definition, which involves both basic and clinical research in the same segment in which scientists take advantage of new discoveries, caused confusion.

To clarify the meaning of the term, NIH updated the definition of translational research in 2007: “ Translational research includes two areas of translation. One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans. The second area of translation concerns research aimed at enhancing the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies is also an important part of translational science ” ( Fig. 55.2 ). The first stage of translational research, which is called T1 research, was described as the movement of discoveries from basic to clinical research. Similarly, the second stage, which is called T2 research, means research that applies the new findings in clinical research to the patient population. Because this updated definition was unidirectional, from basic to clinical research and from clinical research and to patient population, Rubio et al. developed a working definition of translational research. They stated that, “ Translational research fosters the multidirectional integration of basic research, patient-oriented research, and population-based research, with the long-term aim of improving the health of the public. T1 research expedites the movement between basic research and patient-oriented research that leads to new or improved scientific understanding or standards of care. T2 research facilitates the movement between patient-oriented research and population-based research that leads to better patient outcomes, the implementation of best practices, and improved health status in communities. T3 research promotes interaction between laboratory-based research and population-based research to stimulate a robust scientific understanding of human health and disease ” ( Fig. 55.3 ).

In this definition, patient-oriented research represents studies performed to solve the vague questions faced daily in clinical practice, therapy, and care and includes mechanisms of human disease, therapeutic interventions, clinical trials, and development of new technologies. Population-based research conducted on a defined population involves epidemiologic and behavioral studies. As shown in Fig. 55.3 , each type of research no longer has a unidirectional arrow but has a bidirectional arrow; the types of research are closely related to each other.