Data dissemination, clinical trials

Infection risk In an attempt to examine the incidence of serious respiratory infections in patients with rheumatoid arthritis treated with tocilizumab, data from clinical trials and extension studies (tocilizumab cohort), and age- and sex-standardised rheumatoid arthritis patients treated in daily clinical practice in a Tokyo women s facility (subsample cohort), were analysed. Rates of serious respiratory infections were 1.77/100 patient-years from 1999 to 2008 in the tocilizumab cohort studies and 0.53/100 patient-years from 2000 to 2009 in the subsample cohort. After standardising for corticosteroid use, pre-existing pulmonary involvement and disease activity, the risk of serious respiratory infection in the tocilizumab cohort was approximately double that in the subsample cohort regarded as a standard population [209 ]. There may also be an increased risk of disseminated Staphylococcus infections, in particular Staphylococcus aureus, in patients with rheumatoid arthritis treated with tocilizumab [210 ]. 

With the increased acceptance of the Internet and the huge innovations in web development tools, web-based data collection and management systems have become the choice of many CROs because of their capability for collecting clinical trial data in real time and disseminating critical clinical trial information to the participating sites and various oversight committees [27]. 

Upon completion of the Clinical Trial, and any prior publication of multi-centre data, or when the Clinical Trial data are adequate (in Sponsor s reasonable judgement), the NHS Trust may prepare the data deriving from the Clinical Trial for publication. Such data will be submitted to the Sponsor for review and comment prior to publication. In order to ensure that the Sponsor will be able to make comments and suggestions where pertinent, material for public dissemination will be submitted to the Sponsor for review at least sixty (60) days (or the time limit specified in the Protocol if longer) prior to submission for publication, public dissemination, or review by a publication committee. 

It must be said that how such information gets disseminated is controversial in the USA. A good recent example is an investigation of atovaquone vs. i.v. pentamidine in the treatment of mild to moderate Pneumocystis carinii pneumonia. This report included a decision tree to estimate the costs and cost-effectiveness of atovaquone vs. Pentamidine for cotrimoxazole-intolerant patients (Zarkin et al 1996). Clinical outcomes were based on data from a previous randomized controlled trial (RCT) (Phase III) comparing the two medications, while economic outcomes were based on... 

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