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International Clinical Trials

Getting Better

Charlton Ogburn Jr, an American journalist and author, wrote “perhaps because we are so good at organizing, we tend as a nation to meet any new situation by reorganizing; and a wonderful method it can be for creating the illusion of progress while producing confusion, inefficiency and demoralization”. I edited the first edition of European Pharmaceutical Contractor in November 1996 and now, 20 years later, I look back and wonder if the following industry changes have done more than create the illusion of progress:
  • Increased size, duration and cost of trials
  • IT and communication
  • Data protection and production
  • The advent of ‘technology’ leading to vastly more data, more regulation and legislation, and increased patient and investigator involvement
  • Size, development and financial basis of CROs
  • Types of outsourcing and its contracts

Some things have not changed, however, such as time and overall success rate from discovery to marketing; the number and speed of withdrawal of ‘unsuitable’ drugs; and the amount of trials that are delayed or aborted.

We can perhaps define progress as whether medicines are being developed faster, cheaper or better.

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Dr Graham Hughes
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