Category Archives: Uncategorized

Brexit and Clinical Trials_Part 1

Well, the people of Britain have now spoken – albeit not that clearly given a 51.9%:48.1% split in the referendum voting figures. Nevertheless, it’s a democratic decision and now the word on almost everyone’s lips is “Brexit”. Despite a protest … Continue reading

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Statistical Controversies in Reporting of Clinical Trials

In one of the recent issues of the Journal of the American College of Cardiology, Professor Stuart Pocock and colleagues discussed controversies in reporting clinical trial results.  Prof. Pocock is a well-known biostatistician from the Department of Medical Statistics at … Continue reading

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Quality Drivers in Clinical Trial Conduct – Part 2

This study aimed to illustrate how sponsors should measure quality of clinical trials and identify the various drivers of performance.  It was able to actually quantify the magnitude of the relationship between each of the drivers of performance and quality … Continue reading

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Quality Drivers in Clinical Trial Conduct – Part 1

“Quality is never an accident. It is always the result of intelligent effort” (John Ruskin 1819-1900). Quality is an abstract concept and a term with which we are all familiar and tend to take for granted.  It is something to … Continue reading

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AUDIO-VIDEO RECORDING OF INFORMED CONSENT PROCESS_Part 2

In Part 1 we looked at the guidelines [1] for the requirement in India to make AV-recordings of the investigator(s) and patients (and any necessary witnesses/representatives) during the consent process and potential implications [2]. So how, in practice, has this … Continue reading

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AUDIO-VIDEO RECORDING OF INFORMED CONSENT PROCESS_Part 1

Lights, camera, action!  Starring Investigator and trial participants…. Back in November 2013, following a number of scandals in India involving revelations that vulnerable patients were being recruited into unethical clinical trials without proper informed consent, a supreme court order demanded … Continue reading

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An insight into relationships between CROs and Sponsors – Industry survey

The AVOCA group, founded in 1999, is a consulting and survey research firm based in Princeton, NJ. Each year, Avoca conducts industry research to measure current trends in clinical outsourcing and produces a report on the results. This year’s survey, recently … Continue reading

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