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Getting trials done – the Dutch way.

October 2, 2012

Castle Course in Einthoven

Just back from Ben Mol’s clinical research methods course. Amazing.

No fretting about bureaucratic, financial or time constraints. Instead serious discussion about getting the right answer quickly, and protecting patients from ineffective and harmful treatment while still getting what really work to them. Click here for the website.

Ben is having considerable success in persuading health insurers to fund clinical research. You might imagine that each would leave it to the others – they don’t. But neither do they like wasteful gold plating – spending millions to ensure that every nurse who hands out a questionnaire has done a course in research ethics!  It’s difficult to compare systems, and Ben may hide some costs in his clinical service, but the Dutch consortium seems able to rattle off game changing trials much more cheaply than we can.

Consider the recent PPROMEXIL trial of induction v. expectant management for pre-labour rupture of the membranes between 34 and 36 weeks. This recruited 535 participants (target 520 – five times more than the previous largest trial) over 2.5 years, and reported neonatal sepsis, the pre-specified primary endpoint, in all but four. It showed with considerable confidence that induction does not reduce sepsis. Click here for the main publication.

The whole trial, including health economics and an updated meta analysis, cost €400K. It would have cost over £1M in the UK, and taken twice as long to complete.  We have much to learn from the Dutch.

Jim Thornton

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