The challenge and future of clinical research in orofacial pain.

A fter holding the position of Associate F.ditor for 1 year, it seemed to me that offering some perspectives on the future of clinical research in orofacial pain would be a good idea. Enormous achievements m the treatment of acute illness have been witnessed in the past decades. However, it has become increasingly clear that many breakthrough interventions for acute illness have either no value or only limited value in the treatment of chrunic diseases. This unmet healthcare need of subjects with chronic disabling diseases forms the basis for much needed research. Chronic orofaciai pain conditions are no exception in this regard. Careful observation and systematic evaluation of human material is essential to the understanding of disease phenomena or treatment effects. Clinical research, as defined by the United States National Institutes of Health, consists of all biomédical and behavioral research that involves human subjects in which an investigator obtains data through intervention ot interaction with the individuals or uses identifiable , private information. This includes all research that involves the use of human organs, tissues, and body fluids from living individuals, as well as graphic, written, or recorded information that is derived from living individuals. Essential to any meritorious clinical project are a logical study design, an appropriate case definition and study sample, and the employment of valid, reliable clinical measurements. Diagnostic tests should be reproducible, with limited variability attributable to the assessor or data handling process. The number of potential confounding factors should be restricted, or controlled in the study design by the ran-domization of subjects. Known obstacles to quality clinical research include rigid belief systems, which tend to limit the scope of an investigation, and insufficient validity of diagnostic criteria and great observer variation, which invite the erroneous interpretation of findings. While the shortcomings and pitfalls of clinical research are increasingly understood, méthodologie questions often arise in the planning of trials for which a scientifically correct answer is simply not available. Only after essential pilot work on matters of study design will it be possible to launch the full-scale clinical trials that are expected to produce definitive knowledge of disease etiology and intervention. While understanding of the common physical, psy-chologic, social, and economic aspects of patients with orofacial pain defines the personal and societal significance of the problem at hand, the underlying disease mechanisms will likely not be discovered by this kind of desctiptive research. For persistent orofa-cial …