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At least 451 records · Page 25Linked to original sources
PubMed2001

Discrimination of changes in osteoporosis outcomes.

The purpose of this paper was to identify existing work related to discrimination, responsiveness, and minimal clinically important differences (MCID) for 4 key clinical outcomes in osteoporosis, to serve as a background to discussions about how to define MCID for both individuals and groups. The outcomes assessed were bone density, fractures, quality of life, and function. We conducted a systematic literature search in MEDLINE, EMBASE, and Current Contents for articles that discussed responsiveness, detectable difference, improvement criteria, and clinical importance. We used the Beaton cube to classify the studies depending on whether they compared differences between or changes within individuals or groups. Although a number of studies were identified that presented data on detectable differences beyond error and observed differences, few studies presented data on how to define clinically important differences. A key priority for future research is to define minimally clinical important differences for clinically important osteoporosis outcomes using a consensus based approach that will be accepted by the osteoporosis community at large. Furthermore, these MCID will likely be different for individual patients seen in clinical practice than for individuals in a clinical trial.

Clinical Trials as Topic↗
PubMed2001

Towards a definition of "difference" in osteoarthritis.

To assess existing information regarding detectable differences in osteoarthritis (OA), a systematic literature search was conducted up to December 1999. Thirty-three articles were considered methodologically relevant to the definition and categorization of detectable differences in OA. It was determined that the musculoskeletal literature contains a wealth of information that relates to observed changes, much of which is derived from the clinical trials literature, but there have been relatively few methodological studies that have systematically evaluated the nature, categorization, and relevance of the change. Furthermore, most of those that have been published take the perspective of an individual or groups of experts other than that of the patient. This summary of the current literature reveals that the diverse sources of information go part way towards developing an understanding of detectable differences and their importance in the area of OA research and clinical practice. Stakeholders' interests as well as factors that modulate perceptions of importance need to be taken under consideration. In particular, the patient's perspective of the importance of change at an individual level requires further evaluation. This area of clinical research is relatively underdeveloped, but there is considerable opportunity for progress.

Clinical Trials as Topic↗
PubMed2002

[A qualified clinical trial system for cancer chemotherapy, an urgent motion].

Since cancer chemotherapy is generally carried out in the combination form, seldom in single regimen, a new treatment using new drug is not readily available for the clinical use, unless appropriate clinical trial will be performed. Although most clinical trials so far have been used to in the company-oriented-form in our country, new aspects and challenge to the cancer chemotherapy strongly demand to establish stable system to conduct a qualified clinical trial independently conducted from the company. The problems related to this item were analyzed based on the author's own experience of JFMC, and urgent motion was proposed thereupon.

Clinical Trials as Topic↗
PubMed2001

Protecting genetic materials and genetic information: a case study of Guthrie Cards in Victoria.

The authors are privileged to have been provided with correspondence about a dispute over the ongoing storage of genetic material (as Guthrie Cards) in Victoria. The correspondence details confusion over the roles of government and the private sector service provider in accounting for the storage, use and destruction of these stored genetic materials collected as part of a government public health program. The purpose in publishing this account is to highlight the present inadequacies in current practices and the ongoing potential for a crisis in the management of collected genetic materials through a lack of appropriate regulation, transparency and accountability. The article suggests measures to remedy some of the existing inadequacies in contractual arrangements and recommends that the government retain ownership and control of both the genetic materials and the derived information to ensure some accountability in the present legal environment.

Contract Services↗
PubMed2002

WITH: a system to write clinical trials using XML and RDBMS.

The paper illustrates the system WITH (Write on Internet clinical Trials in Haematology) which supports the writing of a clinical trial (CT) document. The requirements of this system have been defined analysing the writing process of a CT and then modelling the content of its sections together with their logical and temporal relationships. The system WITH allows: a) editing the document text; b) re-using the text; and c) facilitating the cooperation and the collaborative writing. It is based on XML mark-up language, and on a RDBMS. This choice guarantees: a) process standardisation; b) process management; c) efficient delivery of information-based tasks; and d) explicit focus on process design.

Clinical Trials as Topic↗
PubMed2003

[Clinical safety data management in company non-sponsored trials].

There is currently no harmonized way in Japan to manage safety data which are obtained during clinical trials supported by Government funds. There are two types of clinical trials, 'sponsored trials(sponsored by industrial companies)' and 'non-sponsored trials(funded by the Government, etc.)'. The Japanese Ministry of Health and Welfare has issued many of pharmaceutical laws(GCP, GPMSP etc.) for the regulation of sponsored trials, while none has ever established for non-sponsored trials, thus leaving the most important quality control/assurance unregulated. In this manuscript we discuss that the simple application of pharmaceutical laws to government-sponsored trials can not be a proper answer because of the different nature of the two types of trials.

Aged↗