Trials of the century

imagesClinical trials have Biblical time frames for a reason – as with everything in medicine ‘Do No Harm’ is the base camp of all research…spending a fortune only to fall short of Everest’s summit is stomach-grindingly disappointing but you fight another day. Taking a header from 27,000 feet because you’ve raced to the peak is infinitely worse. Fatal, is the word.

Big pharma, watching is blockbuster drugs fade, is talking up the need to shorten the trials process in some instances so that they can get treatments to market quicker to help patients and, ahem, get a return on investment.

It is a logical extension of their deft moves to acquire bio-pharma firms who have already done research in key and novel disease areas so the gap between outlay and return is narrowed. Pfizer is now collaborating with 21 US hospitals to identify cell surface research projects with promising futures.

Makes good business sense but the danger is that an accelerated investment return metric could begin to dominate research so rather than scientists pursuing a disease area that badly needs a new treatment they could be diverted to something that promises a swift return. Would orphan disease fit neatly into a ‘smash and grab’ future?

With money running out everywhere, this nuance could skew medical research and, combined with government reluctance to spend, spend, spend on new drugs, the impact will be felt at the sharp end rather than just on the progress charts pinned to marketing department walls.

As we roll inexorably into the personalised medicine era, science and medicine faces the prospect of money dominating even more than ever. How and where research is conducted needs to be an urgent global discussion!

A streamlined trials system should be chased and pharma companies should be allowed to use existing data to give their plans useful go-forward but we abandon clinical trials at our peril. Ben Goldacre mounted a hugely important and successful campaign to secure increased transparency around trials data – will he may now have to turn his investigative/campaigning prowessl to protecting the core of the system?

The crucial element here is that any changes have to be done in clear sight and that any bureaucracy that slows down drug development is shredded quickly so that patients – and pharma companies – don’t have to wait a second longer than they need to get relief.

The financial models of health are changing by the second and the NHS research mandate – one of the few shining parts of the Health & Social Care Act – should be given every chance to succeed.


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