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International Clinical Trials

Editor’s Comment

Greg Ambra and Jean Battikha at DZS Clinical Services wonder “what's the risk?” and, in an attempt to answer this question, discuss risk-based monitoring (RBM), which is becoming increasingly prevalent in the conduct of clinical trials in 2016. They explore how key risk indicators have traditionally (if a recent innovation like RBM can have a tradition) been used in assessing risk, and further outline how central statistical monitoring (CSM) can process all the clinical data collected over the course of a study. Coming to a conclusion, an approach using a CSM plan seems more likely to ensure subject protection and overall site quality than site visits and source document verification alone.

Clara Heering at ICON points out that clinical trial operations are still prone to inefficiencies in the identification of important risks and errors, despite RBM being used to improve this. She notes that one million data points can compose a typical Phase 3 trial, and focusing on all of these can be an extremely wasteful process. One of the methodologies she proposes in order to further evolve RBM is human factor analysis, which is already employed by major non-pharmaceutical companies. The airline sector has, for example, reduced risk by 50%; based on this, she speculates how flawless execution of clinical study diagnostics could, in fact, translate into 50% higher efficiencies in clinical trials as a whole.

Another theme running through the magazine is the use of mobile and electronic devices to assist in the efficient conduct of studies. Nancy Mulligan and Patrick Prugh at UBC observe that mobile technologies have penetrated the vast majority of industries in recent years. Patient health information can now be accessed through smartphones, tablets and other wireless devices, and this access is quickly developing so that workflows surrounding key stakeholders in clinical trials, doctors and patients can be improved. The authors share some guidelines on the most effective ways of utilising these tools, but state that there is no ‘one size fits all’ approach when actually deciding on which ones to use.

Building on the digital side of pharma, further important views on electronic health records (EHRs) in clinical trials is given by Martin Gibson at NorthWest EHealth. He explains that EHRs offer numerous advantages that could potentially transform healthcare and significantly improve both clinical decisions and patient outcomes. These advantages are profound, but designing innovative EHR-based trial methodology that allows for effective development of new drugs while keeping patients safe is very challenging.

Our regional focus this quarter is on India and the Asia- Pacific area. Rich Nelson at PCI Clinical Services looks at why the location of investigational drug studies seems to be following the trend of manufacturing in the Asia- Pacific region, while Vivek Chaturvedi at Hitachi Consulting investigates the reasons underlying the credibility crisis that is enveloping India at present. Finally, in this section, Thanuja Naidu at Pharm-Olam describes ways of reinvigorating interest in conducting clinical trials in India, and the changing regulations that are expected to benefit patients and sponsors alike.

This rich edition of ICT also includes interesting articles on clinical trial supplies, logistics and a question from Mohamed El Malt of Europital regarding CROs: “Does size really matter?” He concludes that, perhaps, size is not everything.

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Graham Hughes
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