Penicillin hypersensitivity: detection by basophil response to challenge.
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The management of osteoarthritis has been limited to symptomatic treatment to decrease pain and improve function without modifying the underlying disease process. New insights into the structure, physiology, and function of cartilage, however, have led to the development of promising approaches that might ultimately modify the underlying disease process. Over the past year, a number of therapeutic trials in osteoarthritis were reported in the literature. These studies provide an opportunity to review methodologic challenges in clinical trials of osteoarthritis.
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Type 2 diabetes (T2D) is a devastating disease with multiple complications affecting many tissues, most notably the cardiovascular system. To be able to prevent a chronic disease such as T2D, certain requirements have to be met. Knowledge about its natural history with a preclinical phase, modifiable risk factors, effective and simple screening tools to identify high-risk subjects, and effective intervention that is affordable and acceptable are necessary. In addition, the efficacy of the intervention has to be proven under a clinical trial setting. Several major lifestyle intervention trials have been successfully carried out, with consistent results: the risk of T2D in high-risk subjects can be halved, the effect of lifestyle changes is rapid, and benefits are similar in different ethnic groups. Thus, the prevention of T2D is possible in most high-risk subjects, but how to achieve this at the population level remains a major challenge.
The Cancer Biotherapy Research Group [CBRG], formerly known as the National Biotherapy Study Group [NBSG], celebrated its 10th anniversary in 1997. CBRG is a not-for-profit cancer clinical trials group of community oncologists whose activities for the most part have been funded by their associated community hospitals. From its inception the Group has focused on clinical investigations of biological agents in the treatment of patients with advanced cancer. This article reviews the history of the Group, its structure, accomplishments, and its current objectives and challenges.
The proper financial administration of clinical trials is becoming a major priority and necessity for involved institutions. The Office of Inspector General in the Department of Justice is sharpening its radar on this growing field. Institutions involved in the conduct of a clinical trial need to become more proactive in the financial management to successfully pass audits and improve financial outcomes. Budget tools standardizing itemized costs can be built to aid clinical trials managers. Using tools already available in a clinic or hospital setting can help even the most junior budget negotiator. Establishing guidelines to streamline and aid the management of a clinical trial program will make managing less challenging.
Ozone (O3) is an air pollutant produced by sunlight-driven reactions involving the oxides of nitrogen and volatile organic compounds. The population of many large metropolitan areas in the US is exposed to high levels of O3, particularly in the summer months. Individuals exposed to O3 levels in human experiments at higher than common ambient levels develop reversible reductions in lung function often associated with symptoms, such as airway hyperreactivity and lung inflammation. Animal models have helped characterize potential mechanisms of lung injury from O3 exposure. Defining the adverse effects of chronic exposure to ambient levels of O3 on lung function and disease have been challenging, in part due to the presence of co-pollutants, such as particulate matter. The US Environmental Protection Agency's 1997 revised standard for O3 (0.08 ppm averaged over 8 hours) is designed to provide better protection to susceptible individuals. The revised standard is being implemented following the failure of court challenges.
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Global control and prevention of meningococcal disease depends on the further development of vaccines that overcome the limitations of the current polysaccharide vaccines. Protein-polysaccharide conjugate vaccines likely will address the marginal protective antibody responses and short duration of immunity in young children derived from the A, C, Y, and W-135 capsular polysaccharides, but they will be expensive to produce and purchase, and may not offer a practical solution to the countries with greatest need. In addition, OMP vaccines have been tested extensively in humans and hold some promise in the development of a serogroup B vaccine, but are limited by the antigenic variability of these subcapsular antigens and the resulting strain-specific protection. Elimination of meningococcal disease likely will require a novel approach to vaccine development, ideally incorporating a safe and effective antigen or antigens common to all meningoccocal serogroups. As a solely human pathogen, however, N. meningitidis has developed many tools with which to evade the human immune system, and likely will pose a formidable challenge for years to come.