Good Clinical Practice (good + clinical_practice)

Distribution by Scientific Domains

Selected Abstracts

Quality assurance within the scope of Good Clinical Practice (GCP),what is the cost of GCP-related activities?

A survey within the Swedish Association of the Pharmaceutical Industry (LIF)'s members
Abstract The bureaucracy that the Good Clinical Practice (GCP) system generates, due to industry over-interpretation of documentation requirements, clinical monitoring, data verifications etc. is substantial. The aim of this study was to estimate the percentage cost of all such GCP-related activities within phase III clinical trials performed in Sweden in 2005. Method: An electronic questionnaire on ICH GCP-activities and their related costs was sent to 47 of the 60 member companies of the Swedish Association of the Pharmaceutical Industry (LIF). Results: The number of respondents was 29, giving a response rate of 62% and covering 97% (n=250) of phase III trials performed in Sweden in 2005. Approximately 50% of the total budget for a phase III study was reported to be GCP-related. 50% of the GCP-related cost was related to Source Data Verification (SDV). A vast majority (71%) of respondents did not support the notion that these GCP-related activities increase the scientific reliability of clinical trials. Copyright 2009 John Wiley & Sons, Ltd. [source]

The role of the monitor in veterinary clinical studies

Iain McPhee
Abstract Regulatory requirements for veterinary clinical studies have developed over the last 24 years. This paper covers the current best practice for the clinical study monitor. It describes and qualifies these activities as outlined in the International Conference on Harmonization of Technical Requirements for Registration of Veterinary Products (VICH) Good Clinical Practice (GCP) guidelines (GL9). Copyright 2006 John Wiley & Sons, Ltd. [source]

Ethical dilemmas in research quality assurance

Hans Lucas
Abstract In this essay three examples of ethical dilemmas in research quality assurance are presented. For one of the examples, dealing with the use of placebo control groups in bio-medical research on humans, the balance between ethical and scientific considerations will be evaluated on basis of a critical review of the applicable standards and/or regulations, such as the Declaration of Helsinki and the current Good Clinical Practice (GCP) regulations. Copyright 2005 John Wiley & Sons, Ltd. [source]

Management tools for the evaluation of compliance and costs in the production of chemical,pharmaceutical companies

Franziska Rank
Abstract Due to the stringent and increasingly demanding Good Manufacturing Practice (GMP) and customer requirements, companies within the chemical,pharmaceutical sector share the enormous challenge of evaluating and measuring compliance and costs. The need for implementing a compliance measuring tool for production was identified within the Schering AG and activities were undertaken. The established compliance evaluation system and the first model for a compliance cost system proved to be well-structured and suitable for the production. Consequently, the systems can be adapted by other areas and chemical,pharmaceutical companies and may even be expanded to other areas, such as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). Copyright 2005 John Wiley & Sons, Ltd. [source]

Injectable opiate maintenance in the UK: is it good clinical practice?

ADDICTION, Issue 4 2001
Deborah Zador
This paper reviews the current practice of injectable opiate treatment (IOT) in the United Kingdom, i.e. the "British system" of prescribing injectable heroin and methadone, and considers some of the clinical and ethical issues it raises. There is very limited research evidence supporting either the safety or effectiveness of IOT as practised in Britain. In particular there is almost no evaluation of long-term outcomes of IOT, which is of potential concern given the possibility of some patients remaining indefinitely in IOT, the risk of vascular complications, and its higher cost compared with oral maintenance. It would be easy to assess this controversial intervention as in need of further research. However, striving towards best practice in IOT involves more than generating evidence. The likelihood of a patient receiving IOT in the United Kingdom appears to be influenced more by the personal inclinations of prescribers than by outcome data (if any), or identified community needs for access to IOT. The author asks is this good clinical practice and is it sustainable? The "British system" needs to modernise itself consistent with international paradigms of continuous quality improvement, and the NHS's own agenda of clinical governance. [source]

Role of cytokines in rheumatoid arthritis: an education in pathophysiology and therapeutics

Marc Feldmann
Summary: Advances in cDNA and monoclonal antibody technology in the 1980s fuelled the discovery and characterization of the properties of cytokines. It became apparent that because cytokines were expressed in tissues derived from autoimmune diseases, they were likely to be of fundamental importance in disease pathogenesis and developing a new class of biological therapeutics. In this review, we describe the history of bench to bedside translation of work that led to the identification of tumor necrosis factor (TNF) as a key regulator of the loss of homeostatic immune-inflammatory responses in rheumatoid arthritis (RA) and a good therapeutic target. First in human clinical trials in collaboration with a biotechnology company, the safety and efficacy of TNF blockade with a chimeric monoclonal antibody was substantiated in patients refractory to standard anti-rheumatoid drugs. Abnormal immune-inflammatory responses after therapy showed improvement and remain a focus of ongoing research in many laboratories. Longer term multi-center studies that followed with several anti-TNF biologicals have demonstrated the augmented efficacy, including inducing clinical remission, of low dose methotrexate and anti-TNF therapy co-therapy, but serious infections and lymphomas in a low frequency have been observed. In the course of the past decades, three ,blockbuster' anti-TNF biologicals are in the clinic. Over a million patients with RA and other immune-mediated diseases have been successfully treated, and a better perspective on the risk of harm and its management has become part of good clinical practice. This success has encouraged a burgeoning industry of biologicals for chronic diseases. [source]

EpiPen epidemic or good clinical practice?

MS Gold
No abstract is available for this article. [source]

Clinical teaching: maintaining an educational role for doctors in the new health care environment

D Prideaux
Context and objectives Good clinical teaching is central to medical education but there is concern about maintaining this in contemporary, pressured health care environments. This paper aims to demonstrate that good clinical practice is at the heart of good clinical teaching. Methods Seven roles are used as a framework for analysing good clinical teaching. The roles are medical expert, communicator, collaborator, manager, advocate, scholar and professional. Results The analysis of clinical teaching and clinical practice demonstrates that they are closely linked. As experts, clinical teachers are involved in research, information retrieval and sharing of knowledge or teaching. Good communication with trainees, patients and colleagues defines teaching excellence. Clinicians can ,teach' collaboration by acting as role models and by encouraging learners to understand the responsibilities of other health professionals. As managers, clinicians can apply their skills to the effective management of learning resources. Similarly skills as advocates at the individual, community and population level can be passed on in educational encounters. The clinicians' responsibilities as scholars are most readily applied to teaching activities. Clinicians have clear roles in taking scholarly approaches to their practice and demonstrating them to others. Conclusion Good clinical teaching is concerned with providing role models for good practice, making good practice visible and explaining it to trainees. This is the very basis of clinicians as professionals, the seventh role, and should be the foundation for the further development of clinicians as excellent clinical teachers. [source]

Evaluation of the Acceptability and Usability of a Decision Support System to Encourage Safe and Effective Use of Opioid Therapy for Chronic, Noncancer Pain by Primary Care Providers

PAIN MEDICINE, Issue 4 2010
Jodie Trafton PhD
Abstract Objective., To develop and evaluate a clinical decision support system (CDSS) named Assessment and Treatment in Healthcare: Evidenced-Based Automation (ATHENA)-Opioid Therapy, which encourages safe and effective use of opioid therapy for chronic, noncancer pain. Design., CDSS development and iterative evaluation using the analysis, design, development, implementation, and evaluation process including simulation-based and in-clinic assessments of usability for providers followed by targeted system revisions. Results., Volunteers provided detailed feedback to guide improvements in the graphical user interface, and content and design changes to increase clinical usefulness, understandability, clinical workflow fit, and ease of completing guideline recommended practices. Revisions based on feedback increased CDSS usability ratings over time. Practice concerns outside the scope of the CDSS were also identified. Conclusions., Usability testing optimized the CDSS to better address barriers such as lack of provider education, confusion in dosing calculations and titration schedules, access to relevant patient information, provider discontinuity, documentation, and access to validated assessment tools. It also highlighted barriers to good clinical practice that are difficult to address with CDSS technology in its current conceptualization. For example, clinicians indicated that constraints on time and competing priorities in primary care, discomfort in patient-provider communications, and lack of evidence to guide opioid prescribing decisions impeded their ability to provide effective, guideline-adherent pain management. Iterative testing was essential for designing a highly usable and acceptable CDSS; however, identified barriers may limit the impact of the ATHENA-Opioid Therapy system and other CDSS on clinical practices and outcomes unless CDSS are paired with parallel initiatives to address these issues. [source]


PAIN PRACTICE, Issue 1 2004
Article first published online: 15 MAR 200
The goals of this study were to establish the frequency of palliative and aggressive treatment measures among patients with and without dementia during the last 6 months of life, to identify relationships between the severity of dementia and aggressive and palliative care, and to determine whether treatment patterns have changed over time. Antemortem data for 279 patients with dementia and 24 control patients who were brought for autopsy in chronic care facilities between 1985 and 2000 were reviewed. The severity of dementia was defined by scores on the Clinical Dementia Rating scale. Data on use of systemic antibiotics (designated as an aggressive treatment measure) and on use of narcotic and nonnarcotic pain medications and nasal oxygen (defined as palliative measures) were collected from medical charts. Fifty-three percent of the patients with dementia and 46% of those without dementia had received systemic antibiotics. Fourteen percent of the patients with dementia and 38% of those without dementia had received narcotic pain medications. The prevalence of aggressive and palliative measures did not vary significantly with the severity of dementia. Eleven percent of the patients with dementia who died between 1991 and 1995 and 18% of those who died between 1996 and 2000 had received narcotic pain medications in the last 6 months of their lives. It was concluded that the use of systemic antibiotics is prevalent in the treatment of patients with end-stage dementia, despite the limited utility and discomfort associated with the use of these agents. Patients with severe dementia and those with milder cognitive impairment received similar treatment may be contrary to good clinical practice, given the poor prognosis of patients with severe dementia. [source]

GCP auditors: hard to find,hard to develop,hard to keep: part III.

Continuous education, further development
Abstract Clinical research is a dynamic and constantly changing discipline. Continuous education of good clinical practice (GCP) auditors is required to guarantee consistent and dependable audit results during their careers. Ongoing training should strive to increase the auditor's capabilities and skills, even beyond GCP. This should not only maintain the quality assurance (QA) auditor in a position to conduct audits according to state-of-the-art methodologies and regulations, but also promote her/his further career development. To be ,fit for purpose' does not only characterize processes meeting defined requirements, but also implies that QA auditors must be continuously trained (hence, ,be fit') to perform high-quality audit services (hence, ,the purpose'). Copyright 2001 John Wiley & Sons, Ltd. [source]

Differences in clinical trial conduct in US and EU investigational sites

Douglas R. Mackintosh
Abstract Observations by clinical auditors about good clinical practice (GCP) compliance in US and EU investigational sites are described. Specific differences between the two regions are noted for institutional review boards (IRBs) and ethics committees; subject recruiting and consenting; investigator/study coordinator qualifications and functions; organization and recording of source data; health care delivery; quality of monitoring; and filing of regulatory documents. Neither region of the world demonstrated GCP superiority in the conduct of its clinical trials. Copyright 2001 John Wiley & Sons, Ltd. [source]