Clinical Trial Service Unit

About: Clinical Trial Service Unit is a based out in . It is known for research contribution in the topics: Population & Stroke. The organization has 428 authors who have published 1387 publications receiving 181920 citations.

Health-Related Quality of Life and Survival of Cholangiocarcinoma Patients in Northeastern Region of Thailand.

Abstract: In northeast Thailand, cholangiocarcinoma (CCA) is a major cause of mortality. Patients with CCA have a poor prognosis and short-term survival. The purpose of this study was to investigate the association between health-related quality of life (HRQOL) and survival time, and to explore whether change in HRQOL score is related to survival among CCA patients. The study was performed between February 2011 and January 2012, and included 171 patients with newly diagnosed CCA from 5 tertiary hospitals in four provinces of northeast Thailand. The HRQOL was measured at baseline, 1 month, and 2 months after diagnosis by the FACT-Hep questionnaire (Thai version 4). The outcome was survival time from diagnosis. Cox's proportional hazard model was used to evaluate the association between HRQOL and survival time. A higher overall score on HRQOL was associated with a significantly better survival (HR per 5 units increase in HRQOL was 0.92, 95% CI: 0.88-0.96). Two of the separate domains contributing to the overall HRQOL-functional well-being and hepatobiliary cancer subscale-were found to have independent effects on survival, even after adjustment for potential confounding variables, and the other domains of HRQOL. CCA patient whose HRQOL scores had improved (≥9 units) at the 1st month of follow up had a reduced probability of dying from the disease (HR: 0.56, 0.32-0.95) after adjustment for the same confounding factors. A positive association between HRQOL at diagnosis and survival time was found. An improvement in HRQOL score in the first months after diagnosis further increases survival.

Associations of domain-specific physical activities with insomnia symptoms among 0.5 million Chinese adults.

Abstract: Previous studies have demonstrated the association between physical activity and sleep quality. However, there is little evidence regarding different domains of physical activity. This study aimed to examine the associations between domain-specific physical activities and insomnia symptoms among Chinese men and women. Data of 452 024 Chinese adults aged 30-79 years from the China Kadoorie Biobank Study were analysed. Insomnia symptoms were assessed with self-reported difficulties in initiating or maintaining sleep, early morning awakening, daytime dysfunction and any insomnia symptoms. Physical activity assessed by questionnaire consisted of four domains, including occupational, commuting-related, household and leisure-time activities. Gender-specific multiple logistic regression models were employed to estimate independent associations of overall and domain-specific physical activities with insomnia symptoms. Overall, 12.9% of men and 17.8% of women participants reported having insomnia symptoms. After adjustment for potential confounders, a moderate to high level of overall activity was associated with reduced risks of difficulties in initiating or maintaining sleep and daytime dysfunction in both sexes (odds ratios range: 0.87-0.94, P < 0.05). As to each domain of physical activity, similar associations were identified for occupational, household and leisure-time activities in women but not men (odds ratios range: 0.84-0.94, P < 0.05). Commuting-related activity, however, was associated with increased risks of difficulties in initiating or maintaining sleep and any insomnia symptoms in both sexes (odds ratios range: 1.07-1.17, P < 0.05). In conclusion, a moderate to high level of physical activity was associated with lower risks of insomnia symptoms among Chinese adults. However, such associations varied hugely in different domains of physical activity and with gender differences, which could help with better policy-making and clinical practice.

Risk-adapted approaches to the management of clinical trials: guidance from the Department of Health (DH)/Medical Research Council(MRC)/Medicines and Healthcare Products Regulatory Agency (MHRA) Clinical Trials Working Group

Abstract: In 2009, the Department of Health asked the MRC and MHRA to identify major obstacles to non-commercial clinical trials research in the UK and suggest remedial actions. Risk-proportionality in trial management and monitoring was identified as a key area and a sub-group formed to: • Develop a process to facilitate the agreement of key stakeholders on the level of risk associated with a clinical trial of an investigational medicinal product (CTIMP). • Identify how risk-adapted approaches for CTIMPs can be achieved within the current regulatory framework. • Develop guidance on risk assessment and the risk-proportionate management of clinical trials. The resulting guidance focuses on the risks inherent in a trial protocol which impact on participant safety and rights, and the reliability of the results. A two-part assessment is suggested: 1) a simple IMP risk categorisation based on marketing status and standard medical care, and 2) assessment of the trial design, population and procedures to identify specific areas of vulnerability. The first part, IMP risk category, has implications for simplifications of initiation and conduct of a CTIMP that may be possible within the current regulatory framework. Possible risk-adaptations include: the need for competent authority authorisation; content of the Clinical Trials Authorisation (CTA) application; IMP management; safety surveillance; trial documentation; and GCP Inspection. The risks associated with the IMP also determine trial procedures for monitoring participant safety. The second part of the risk assessment addresses other aspects of clinical trial design and methods: safety risks from clinical procedures; risks related to participant rights; and risks to the reliability of trial results. It is designed to help trialists identify potential vulnerabilities and to prepare tailored trial management and monitoring plans to minimise risks which may be reviewed and modified throughout the life of a trial. The IMP risk category and safety monitoring plan may be submitted to the MHRA with the CTA application to ensure that there is shared understanding on this key aspect of a trial. We hope that the entire risk assessment and associated plans will provide the basis for a common understanding of stakeholders of the risks for that trial, and facilitate a risk-proportionate approach to trial activities. The guidance is available on the MHRA and NETSCC websites.

Asymptomatic carotid artery stenosis: who should be screened, who should be treated and how should we treat them?

Abstract: Although stopping smoking, lowering blood pressure and reducing lipid levels will reduce global stroke risk and cardiovascular mortality, these remain leading causes of death and disability especially in ageing populations. Further prevention strategies are needed and, in the first part of this review, we explore the potential benefits of appropriate screening for carotid artery disease to reduce stroke and identify those who may have related cardiac disease. Although whole-population carotid screening is an inefficient and costly means of identifying candidates with tight carotid stenosis who might warrant intervention, it can identify many people with lower levels of stenosis who may benefit from cardiovascular risk-reducing medications. Longer-term benefits and cost-effectiveness of any targeted screening program needs further evaluation. Patients with carotid stenosis are known to be at increased risk of stroke and vascular death. Whilst randomized clinical trials and guidelines have reported stroke hazards and benefits of interventional treatment for carotid stenosis, uncertainty remains about their optimal medical management. In the second part of this review we discuss Level I evidence for medical and surgical treatment of asymptomatic carotid stenosis, reasons for the current lack of consensus on interventional management of these patients and future studies which may help to clarify which groups will (and which will likely not) benefit from interventions.