A group of charities in the U.K. is spearheading an effort to modify the EU's Clinical Trials Directive, a set of regulations which was intended to improve the safety of drug studies and which critics maintain has driven up the cost of studies and threatened to wipe out the drug research business in Europe.
According to The Telegraph, Cancer Research UK has joined a coalition that insists the directive created a battery of onerous regulations which significantly added to the cost of research without doing anything to improve safety.
"We are driving a Rolls Royce organization down a cart track, in terms of the bureaucracy and impediments that we have to overcome along the way," Cancer Research UK chief clinician Professor Peter Johnson tells the British newspaper. "The directive has just about doubled our costs for maintaining a portfolio of trials, because the cost of manpower pretty much doubled."
As an example, Johnson cites how requirements on reporting every adverse effect in a study prevented investigators from setting out to determine whether a common nutrient--with a clear safety profile--should be added to a cancer treatment. And with the number of clinical trials in the U.K. dwindling as the drug R&D industry finds itself being slashed by Big Pharma, the critics maintain that lawmakers need to act now, before the clinical trial business in Europe finds itself outsourced entirely to other, less expensive, regions of the world.
The group may have picked a poor example to make their case, though. Even if nutrients or other additives with a clear safety profile may get a pass on some of the regulations in the directive, it's unlikely that developers would be allowed to do a study of any new drug or drug combo without being required to report on adverse events. Modifying the directive in that one respect may do little to bring down the cost of any true drug study.
- here's the story from The Telegraph