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Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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At least 127 records · Page 7Linked to original sources
PubMed1996

Clinical trials: what more is needed? A critical view.

TRADITIONAL DIVISIONS OF MEDICAL RESEARCH: Medical research has been traditionally classified as "basic' and "applied'. The latter category has tended to emphasize the value of randomized controlled trials. These, however, cannot be applied to routine clinical care without considerable extrapolation. There is a further need for research into optimal methods of health care delivery directed at improving the standards of treatment and taking account of such factors as socio-economic need and barriers to access. REQUIREMENT FOR AN INTEGRATED PROGRAMME OF RESEARCH: If the full opportunities offered by scientific research are to be exploited, an integrated programme of research is required which extends from the basic to the applied and which recognizes the traditional, end-point, controlled trial as only one component in a spectrum of scientific activity.

Antihypertensive Agents↗
PubMed1999

Pharmacoeconomics research credibility: a controversial and recurring theme in health outcomes research.

OBJECTIVE: This paper provides a framework for and discussion of the continued development and adoption of good health outcomes practice with application to health outcomes research. METHODS: We explored the issue of credibility in health outcomes research, including efforts within academia, governments, industry, and other interested parties to elevate the standard of health outcomes research to that currently expected of clinical research. A large percentage of health outcomes research programs are designed, implemented, and funded through efforts of the pharmaceutical industry; this fact casts doubt on the validity of study findings, with the result that these results often may be disregarded entirely. CONCLUSIONS: The constantly increasing need to demonstrate value for money in the context of health-care interventions is likely to continue as the need for continued high quality medical care persists and health-care budgets decline. Efforts aimed at guiding healthcare expenditures, such as health outcomes research, require further examination and attention.

Conflict of Interest↗
PubMedDate not supplied

Quality of Japanese clinical trials estimated from good clinical practice audit findings.

To describe qualitatively recent changes in the Japanese clinical trial environments, we compared the results of the Good Clinical Practice (GCP) audits conducted from April 1997 to March 2000 (FY1997 to FY1999) with those from April 2002 to March 2003 (FY2002). In addition, the audit results were compared between the United States and Japan. The audit findings in the former period were based on the official audits by the Organization for Pharmaceutical Safety and Research (OPSR) that covered 331 hospitals and 775 trials. The audits by the OPSR in the latter period targeted 136 hospitals and 226 trials. The total number of deficiencies detected in the Good Clinical Practice audits in the former 3-year period (FY1997 to FY1999) was 1529, and the number in the single year (FY2002) was 1627. The total number of deficiencies detected and reported was about 3-fold on an annual basis between the periods. By category of deficiencies, there were 2 remarkable changes in the OPSR's audit findings between FY1997-FY1999 and FY2002. One was an increase in the proportion of protocol deviations from 14.7% (225/1529) in FY1997-FY1999 to 48.2% (785/1627) in FY2002, and the other was a decrease in the proportion of case report form-related deficiencies from 43.6% (666/1529) to 16.0% (260/1627). The high prevalence of protocol nonadherence and the relatively few findings of informed consent errors were important characteristics of Japanese trials inferred from the audit result reported by the OPSR in FY2002. In the United States, relatively high proportions of protocol nonadherence and informed consent errors were observed in the audit finding reported in 1997. Although the audit results for clinical trials between the United States and Japan are not strictly comparable, our results suggest that protocol deviations are a compelling issue for quality improvement in the conduct of clinical trials for the 2 regions.

Clinical Trials as Topic↗
PubMedDate not supplied

Getting people to want sliced bread--an update on dissemination of the Guide to Community Preventive Services.

This article provides an overview and update on dissemination strategies regarding the Guide to Community Preventive Services (Community Guide), a federally sponsored and independently led initiative to develop evidence-based findings on the effectiveness of selected population-based interventions. Despite the innovative nature, barriers to dissemination and utilization of Community Guide findings exist. Terms and concepts used to guide dissemination efforts designed to address these barriers are identified and discussed.

Decision Making, Organizational↗
PubMed2003

Developing strategies for psychopharmacological studies in preschool children.

OBJECTIVE: To identify the obstacles and special challenges-ethical, practical, scientific, and regulatory-faced by investigators who attempt to conduct psychopharmacological studies in preschoolers. METHOD: In a workshop held at the 47th Annual Meeting of the American Academy of Child and Adolescent Psychiatry, featuring interactive sessions designed to elicit discussion of the theory and feasibility of research in this young population, several key domains were identified: diagnosis and assessment, ethics, research design, special considerations for preschoolers, regulatory/industry issues, and education/training. RESULTS: A Pediatric Psychopharmacology Initiative is needed to consolidate recommendations from this and other workshops and current federal, research, and regulatory committees. A scholarly review and a guide for institutional review boards and investigators should be prepared on issues related to preschoolers. Developmental specialists provide valuable expertise that can strengthen studies of pediatric psychopharmacology. "N of 1" case studies can provide valuable information to clinicians. Only preschoolers with severe symptoms that occur in several interpersonal contexts should be entered into trials. Indications for the study of symptom complexes (e.g., aggression) rather than specific diagnoses should be examined and considered for regulatory activities. Psychopharmacology practice parameters for preschoolers are needed. CONCLUSIONS: With preschoolers being increasingly treated with psychopharmacological agents, the need for investigations to address the safety and efficacy of these medications is becoming a central issue for researchers from many disciplines.

Adolescent↗
PubMed2004

Provider perceptions of pharmacy management: lessons from the military health system.

OBJECTIVE: The objective of this study was to contrast experiences and opinion of providers in military treatment facilities, where a single formulary is used, with those of community providers where multiple formularies and preferred lists are commonly encountered. STUDY DESIGN: We conducted cross-sectional surveys. SETTING: The study was conducted at military and community practices that serve military beneficiaries. PARTICIPANTS: We studied randomly selected clinicians, stratified by military treatment facility (MTF) size or number of military beneficiaries served. The final samples included 566 eligible MTF and 557 private clinicians, with 69% and 38% response rates, respectively. OUTCOME MEASURES: We wanted to determine experiences with and opinions of formularies and/or preferred lists and related policies. RESULTS: Sixty-three percent of military providers were very familiar with formulary content and 60% with nonformulary request procedures; 67% thought their formulary was up-to-date and 84% felt Pharmacy & Therapeutics (P&T) committees were responsive to providers. In contrast, 23% of community providers felt very familiar with (multiple) formulary content and 10% with nonformulary request procedures. Only 15% perceived that formularies were current and 34% thought P&T committees were responsive to providers. Statistically significant differences remained after analysis of potential bias. CONCLUSIONS: Community providers were less aware and less satisfied with pharmacy benefits management policies than military providers, likely as a result of their daily interactions with multiple, unrelated pharmacy management systems. Addressing the problems expressed by community providers is imperative for pharmacy benefits managers.

Adult↗
PubMed2005

Good clinical practice: historical background and key aspects.

Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for anyone involved. In this review article, key aspects of GCP and the responsibilities of investigators, monitors and sponsors are described. In addition, a comprehensive overview of the historical background on the development of GCP from the US Pure Food and Drugs Act of 1906 over the Nuremberg Code, the Kefauver-Harris Amendments and the Declaration of Helsinki until now is given. Knowledge of the historical background may help understand the developments in GCP.

Clinical Trials as Topic↗
PubMed1995

An evaluation of TQM in primary care: in search of best practice.

Presents an evaluation of a TQM initiative which was designed to help the general level of awareness and knowledge within general practices and to encourage the implementation of TQM in primary care. The purposes of the initiative were to assess the effectiveness of the TQM approach used, not only in terms of tangible results but also in terms of cost effectiveness suitability and workability; and to check the transferability of the model used and its replicability with similar levels of benefits in other general practices on a nationwide basis.

Awareness↗