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PubMed2006

An industry perspective on the NIMH consensus statement on negative symptoms.

Negative symptoms of schizophrenia remain an area of substantial unmet clinical need. By convening a consensus conference in January 2005, the NIMH has taken a leading role in stimulating a resurgence of interest in methodological considerations related to development of new medications for treating negative symptoms. One audience for this work is clinical researchers in industry. They must take ideas, like those emerging from this consensus meeting, and determine whether they can be applied to their global trials in order to meet the needs of a broad group of customers, which include patients, clinicians, regulators, and payers. This article takes the ideas that surfaced from the NIMH consensus work and interprets them in terms of issues that industry faces for its clinical trials. Particular emphasis is given to addressing hurdles to study design and analysis that come when developing broad-spectrum or adjunctive agents that may be effective for negative symptoms.

Antipsychotic Agents↗
PubMed1993

National Institutes of Health Consensus Development Conference Statement on Diagnosis and Treatment of Early Melanoma, January 27-29, 1992.

The National Institutes of Health Consensus Development Conference on Diagnosis and Treatment of Early Melanoma brought together experts in dermatology, pathology, epidemiology, public education, surveillance techniques, and potential new technologies, as well as other health care professionals and the public, to address (a) the clinical and histological characteristics of early melanoma; (b) the appropriate diagnosis, management, and follow-up of patients with early melanoma; (c) the role of dysplastic nevi and their significance; and (d) the role of education and screening in preventing melanoma morbidity and mortality. Following 2 days of presentations by experts and discussion by the audience, a consensus panel weighted the evidence and prepared a consensus statement. The panel agreed (a) that melanoma in situ is a distinct entity that can be treated effectively by surgery with 0.5-cm margins and that thin, invasive melanoma < 1 mm thick has the potential for long-term survival in < 90% of patients after surgical excision with a 1-cm margin; (b) that elective lymph node dissections and extensive staging evaluations should not be recommended in early melanoma; (c) that patients with early melanoma are at low risk for relapse but may be at high risk for development of subsequent melanomas and therefore should be followed closely; (d) that some family members of patients with melanoma are at increased risk for melanoma and therefore should be enrolled in surveillance programs; and (e) that education and screening programs have the potential to decrease morbidity and mortality from melanoma. The full text of the consensus panel's statement follows.

Humans↗
PubMed1993

Pathology and prognostic factors.

Cutaneous malignant melanoma and its precursors were the general subjects of the National Institutes of Health Consensus Conference held in January 1992. Particular emphasis was placed on the diagnosis of early melanoma, especially melanoma in situ, and the controversies surrounding dysplastic nevi. Recent studies of unusual nevi often confused with melanoma, eg, deep-penetrating (plexiform) nevus, combined nevus, desmoplastic melanocytic nevus, and Spitz nevus in childhood, provided detailed histologic criteria for their discrimination from melanoma. Rare or unusual forms of melanoma, including desmoplastic melanoma, neurotropic melanoma, a newly described variant angiotrophic melanoma, subungual melanoma, and balloon cell melanoma have been the subject of comprehensive histologic studies. Other histopathologic investigations have described the prevalence of histologic regression and intraepidermal pagetoid spread in melanomas and the histologic features of reexcision specimens of melanoma. New evidence suggests that the predominant cell type infiltrating melanoma is the monocyte-macrophage, and the expression of monocyte chemotactic protein-1 by melanoma may explain the recruitment of this cell type. Immunopathologic studies of melanocytic lesions were performed with various melanocyte-associated antigens (eg, HMB-45), proliferation antigens (eg, Ki-67), and progression markers (eg, epidermal growth factor receptor and HLA-DR). HMB-45 binding has been localized ultrastructurally to early melanosome formation. Various prognostic factors, including gender, high-risk anatomic sites (particularly the scalp), race (black vs white patients), microscopic satellites, tumor volume, indices of proliferation and tumor cell motility, volume-weighted mean nuclear volume, DNA ploidy, and nucleolar organizer regions have been the subject of recent investigations. Analysis of many patients with long-term follow-up has facilitated better prognostic modeling of melanoma.

Diagnosis, Differential↗
PubMed2003

A summary of evidence on radiation exposures received near to the Semipalatinsk nuclear weapons test site in Kazakhstan.

The presently available evidence about the magnitude of doses received by members of the public living in villages in the vicinity of Semipalatinsk nuclear test in Kazakhstan, particularly with respect to external radiation, while preliminary, is conflicting. The village of Dolon, in particular, has been identified for many years as the most highly exposed location in the vicinity of the test site. Previous publications cited external doses of more than 2 Gy to residents of Dolon while an expert group assembled by the WHO in 1997 estimated that external doses were likely to have been less than 0.5 Gy. In 2001, a larger expert group workshop was held in Helsinki jointly by the WHO, the National Cancer Institute of the United States, and the Radiation and Nuclear Safety Authority of Finland, with the expressed purpose to acquire data to evaluate the state of knowledge concerning doses received in Kazakhstan. This paper summarizes evidence presented at that workshop. External dose estimates from calculations based on sparse physical measurements and bio-dosimetric estimates based on chromosome abnormalities and electron paramagnetic resonance from a relatively small sample of teeth do not agree well. The physical dose estimates are generally higher than the biodosimetric estimates (1 Gy or more compared to 0.5 Gy or less). When viewed in its entirety, the present body of evidence does not appear to support external doses greater than 0.5 Gy; however, research is continuing to try and resolve the difference in dose estimates from the different methods. Thyroid doses from internal irradiation, which can only be estimated via calculation, are expected to have been several times greater than the doses from external irradiation, especially where received by small children.

Chromosome Aberrations↗