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.

Kidney disease trials for the 21st century: innovations in design and conduct.

Abstract: Compared to other specialties, nephrology has reported relatively few clinical trials, and most of these are too small to detect moderate treatment effects. Consequently, interventions that are commonly used by nephrologists have not been adequately tested and some may be ineffective or harmful. More randomized trials are urgently needed to address important clinical questions in patients with kidney disease. The use of robust surrogate markers may accelerate early-phase drug development. However, scientific innovations in trial conduct developed by other specialties should also be adopted to improve trial quality and enable more, larger trials in kidney disease to be completed in the current era of burdensome regulation and escalating research costs. Examples of such innovations include utilizing routinely collected health-care data and disease-specific registries to identify and invite potential trial participants, and for long-term follow-up; use of prescreening to facilitate rapid recruitment of participants; use of pre-randomization run-in periods to improve participant adherence and assess responses to study interventions prior to randomization; and appropriate use of statistics to monitor studies and analyse their results. Nephrology is well positioned to harness such innovations due to its advanced use of electronic health-care records and the development of disease-specific registries. Adopting a population approach and efficient trial conduct along with challenging unscientific regulation may increase the number of definitive clinical trials in nephrology and improve the care of current and future patients.

High prevalence of potentially virulent strains of Helicobacter pylori in the general male British population

Abstract: BACKGROUND Strains of Helicobacter pylori that express the cytotoxin associated gene product A (CagA) may be more strongly associated with serious gastric diseases, such as gastric cancer and peptic ulceration, than other strains. Data, however, are sparse on the prevalence, risk factors, and other correlates of these strains in the general popu- lation. AIM To characterise aspects of the seroepidemiology of CagA + strains of H pylori in the general British population. METHODS We measured serum IgG antibodies to mixed H pylori antigens and separately to CagA in 1025 men aged 40–59 years who were randomly selected from a larger group of participants in a community based survey conducted in 18 different British towns. RESULTS Overall, 44% (95% confidence interval 41–47%) of the men were seropositive to CagA antibodies, representing about 61% (57–65%) of the men seropositive to mixed antigen H pylori . The risk factors for seropositivity to CagA antibodies were similar to those for seropositivity to mixed antigen H pylori , apart from an increased prevalence of reported bedroom sharing in childhood (p CONCLUSION In a nationwide study of potentially virulent H pylori strains, there was a high prevalence of the infection, with some evidence that acquisition of such strains might occur earlier in life than other strains.

Examination of potential novel biochemical factors in relation to prostate cancer incidence and mortality in UK Biobank.

Abstract: Background Although prostate cancer is a leading cause of cancer death, its aetiology is not well understood. We aimed to identify novel biochemical factors for prostate cancer incidence and mortality in UK Biobank. Methods A range of cardiovascular, bone, joint, diabetes, renal and liver-related biomarkers were measured in baseline blood samples collected from up to 211,754 men at recruitment and in a subsample 5 years later. Participants were followed-up via linkage to health administrative datasets to identify prostate cancer cases. Hazard ratios (HRs) and 95% confidence intervals were calculated using multivariable-adjusted Cox regression corrected for regression dilution bias. Multiple testing was accounted for by using a false discovery rate controlling procedure. Results After an average follow-up of 6.9 years, 5763 prostate cancer cases and 331 prostate cancer deaths were ascertained. Prostate cancer incidence was positively associated with circulating vitamin D, urea and phosphate concentrations and inversely associated with glucose, total protein and aspartate aminotransferase. Phosphate and cystatin-C were the only biomarkers positively and inversely, respectively, associated with risk in analyses excluding the first 4 years of follow-up. There was little evidence of associations with prostate cancer death. Conclusion We found novel associations of several biomarkers with prostate cancer incidence. Future research will examine associations by tumour characteristics.