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.

High Levels of C-Reactive Protein Are Associated with an Increased Risk of Ovarian Cancer: Results from the Ovarian Cancer Cohort Consortium

Abstract: Growing epidemiologic evidence supports chronic inflammation as a mechanism of ovarian carcinogenesis. An association between a circulating marker of inflammation, C-reactive protein (CRP), and ova ...

Alcohol and coronary heart disease reduction among British doctors: confounding or causality?

Abstract: Alcohol and coronary heart disease reduction among British doctors: confounding or causality? In the absence of experimental evidence, the interpretation of observed associations may be difficult unless they are exceptionally strong. There is no simple rule for distinguishing between associations of moderate strength that are partly or wholly causal and those that are entirely due to confounding between the factor under study and some other factor that is actually a cause of the disease. All importantly relevant evidence has to be taken into account, including the biological plausibility of causality. Several epidemiological studies have found an inverse association between the consumption of alcohol and coronary heart disease, and many authors have concluded that the most plausible explanation is that alcohol can be somewhat protective. Some, however , remain unconvinced. Shaper' 11 , for example, believes that the inverse association may well arise just because the non-drinking group is 'particularly predisposed to ill-health in all forms, and for several reasons, most particularly predisposed to coronary heart disease'. One widely discussed possibility is that the non-drinking group includes a substantial proportion of ex-drinkers who have given up alcohol because they already had heart disease, but the inverse relationship holds even after ex-drinkers have been excluded' 2 \" 41 and it also holds among men and women with no self-reported history of coronary heart disease in the past' 3 ' 5 \" 81. The other possible non-causal explanation for the observed inverse association involves confounding , lifelong abstainers being at relatively high risk because of some personal characteristics that affect the risk of the disease (other than the effects of their abstinence, or their past history of coronary disease). In our 1978-91 prospective study of mortality in relation to the consumption of alcohol in British doctors' 6 ' we, like many others, found that moderate alcohol consumption was associated with a reduction in mortality from vascular disease (Fig. 1) and concluded that the apparently protective effect was likely to be partly or wholly real. Shaper' 91 , however, has t I 0 21 42 63 Units (U.K.) of alcohol per week in 1978 questionnaire Figure 1 Trend in mortality from vascular disease (is-chaemic heart disease and stroke and residual vascular; ICD 9th revision 401-459) with consumption of alcohol (U.K. units per week) in British doctors 1978-1991. Floating absolute risk and 95% confidence interval, standardized for exact age and smoking. proposed that the lower …

Failure of a new protocol to improve treatment results in paediatric lymphoblastic leukaemia: lessons from the UK Medical Research Council trials UKALL X and UKALL XI.

Abstract: The impact of various types of intensification therapy was examined in a cohort of 3617 children aged 1-14 years with acute lymphoblastic leukaemia (ALL) enrolled in the Medical Research Council (MRC) UKALL X (1985-90) and UKALL XI (1990-97) trials. UKALL XI was modified in 1992 to incorporate the "best arm" of UKALL X with two 5-d intensification blocks at 5 and 20 weeks, and an additional randomization in respect of a third intensification at 35 weeks but omission of two consecutive injections of daunorubicin during induction. All children were eligible for randomization irrespective of risk group. The impact of the various types of intensification therapy was examined in a stratified analysis. At a median follow up of 102 months, both trials had an identical event-free survival of 61% (95% CI 58-63%) at 8 years. Survival at 8 years in UKALL XI was significantly better in than in UKALL X, 81% (79-83%) compared with 74% (72-76%) (P = or = 50 x 10(9)/l (P = 0.002). Introduction of a third late intensification block compensated for omission of anthracyclines during induction but produced little additional benefit. These results show, in a large cohort of patients, that minor modifications of therapy may influence relapse rate and obviate the benefit of previous randomized trials. The failure to adapt treatment for higher risk children contributed to these disappointing results.

Data sharing in clinical trials - practical guidance on anonymising trial datasets

Abstract: There is an increasing demand by non-commercial funders that trialists should provide access to trial data once the primary analysis is completed. This has to take into account concerns about identifying individual trial participants, and the legal and regulatory requirements. Using the good practice guideline laid out by the work funded by the Medical Research Council Hubs for Trials Methodology Research (MRC HTMR), we anonymised a dataset from a recently completed trial. Using this example, we present practical guidance on how to anonymise a dataset, and describe rules that could be used on other trial datasets. We describe how these might differ if the trial was to be made freely available to all, or if the data could only be accessed with specific permission and data usage agreements in place. Following the good practice guidelines, we successfully created a controlled access model for trial data sharing. The data were assessed on a case-by-case basis classifying variables as direct, indirect and superfluous identifiers with differing methods of anonymisation assigned depending on the type of identifier. A final dataset was created and checks of the anonymised dataset were applied. Lastly, a procedure for release of the data was implemented to complete the process. We have implemented a practical solution to the data anonymisation process resulting in a bespoke anonymised dataset for a recently completed trial. We have gained useful learnings in terms of efficiency of the process going forward, the need to balance anonymity with data utilisation and future work that should be undertaken.