My colleague Trudie Lang is the nearest thing I know to a superhero. Bounding with energy and enthusiasm, which is something of a necessity as she does trials in some of the poorest places around the world and frequently does that research in the eye of the storm of a major disease outbreak. First Ebola and now Zika have taken up most of her time so that if you try to find her in Oxford she probably won’t be there. She is one of the driving forces behind MoreTrials.
Zika meant she had to pull out at the last minute from attending the recent ICH meeting in Lisbon, but in a letter to ICH Trudie has laid out the various problems that ICH-GCP has caused in some of the world’s poorest countries.
Of course, If you have deep pockets, let’s say you are developing a new drug that has the potential to make substantial future profit, you can get around these problems by throwing more money at it. It’s not very efficient, but it works. But if your pockets have holes in them, then you don’t do the research.
The letter also highlights what might be the biggest obstacle to change; Contract Research Organisations (CROs). If your business depends on making money from activity rather than outcomes you might therefore not want to do things more efficiently.
If you make more money by sending people out to monitor the data at the site rather than doing it remotely using a computer, what would you choose?
If you get paid more money for checking all of the data collected rather than just the data that really matters, what would you choose?
Along with the Marvel cape, Trudie also has a great sense of humour and the camel and the racehorse analogy was how she first described to me the problems with the ICH-GCP guideline and the ICH committee that created it and which Nick White and her nicely summarised in their 2001 Lancet paper, “Clinical Research: time for sensible global guidelines.” The opening sentence will give you a flavour of the problem:
“Clinical research is being slowly strangled by bureaucracy because guidelines that were developed for product-registration trials are being applied rigidly to all types of clinical research.”
A month has passed since the ICH meeting in Lisbon. We are eagerly waiting for their response.