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International Clinical Trials

Editor’s Comment

Bill Clinton once said when commenting on elections “it is the economy, stupid.” When discussing clinical research, forgetting that “it is the patient, stupid” is easy. The patient must always be at the centre of considerations from initial research to commercialisation. This concept is explored by Justin Schroeder at PCI Pharma Services (EPC page 44). He reiterates a famous quote from the US Surgeon General that “drugs don’t work in people that don’t take them” and regrets that as few as 30-40% of patient prescriptions are taken in a compliant manner. One way to improve patient compliance is in the design of the trials that contribute towards the approval of drugs, bearing in mind the dictum “drugs are not approved as such, their labels are”, so the better the label, the better the patient compliance. Jeff Lee at Bracket expands on these thoughts, exploring how sponsors can strengthen their perception of patient centricity, thereby improving recruitment, retention, and protocol adherence within the trial (page 30).

The patient becoming more tech-savvy should, in principle, make the application of technology to trials easier, provided that sponsors can develop the necessary mechanisms. Some of these new tools are described by Aaron Fleishman and Sarah Mandracchia at BBK Worldwide, concentrating on the use of modern techniques for managing study timelines and budgets (page 18).

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Dr Graham Hughes
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