Pharmaceutical companies which make extensive use of contract clinical research organisations (CROs) tend to enjoy faster development times for their projects, according to data provided by the Tufts Center for the Study of Drug Development in the USA.
Sponsor companies who were high CRO users are more likely to submit marketing application within 30 days of the projected submission date than low users, said Dr Christopher Milne, assistant director of Tufts CSDD, at the Pabord conference in London.
But interestingly there was no difference between in-house clinical research and the outsourced variety in terms of the quality of the work carried out, with just one exception: High users of CROs for pivotal trials also had a significantly shorter time from the last patient visit in a study to data lock than low users, at 42 days versus 56 days, respectively.
And with the pharmaceutical industry facing the double whammy of spiralling R&D costs and lengthening clinical development times – as well as a reduction in the number of new drugs coming to market – it is unsurprising that Tufts’ data indicates that drugmakers are turning to CROs to carry out more clinical development.
The cost of developing a new drug has risen from $800 million in 1997 to $1.1 billion in 2001, and could reach $1.9 billion by 2013 if the current trend continues, said Milne, citing data from a seminal paper by Joseph DiMasi that was published in the Journal of Health Economics in 2003.
The cost of clinical trials accounts for the bulk of the overall cost of drug development – and given that the time spent on them has obstinately stayed at around 40%-50% of the total 13-14 years of a typical drug development project – the rationale for greater use of outsourcing is clear.
The data bear out this view. Global spending on clinical services outsourcing grew at a rate of more than 15% a year between 2001 and 2004, outstripping the 11% growth in overall clinical development spending, said Milne.
Outsourced clinical research (not including pass-through clinical services like central lab and investigator grants) reached around $5.6 billion in 2004, or around 15% of the total $37.7 billion spend across the industry. Back in 2001 it accounted for 13.5%, he told the meeting.
Milne believes that the trend toward outsourcing will continue, even though the clinical landscape is changing more now than at any time in recent decades. New technologies such as adaptive trial design, microdosing, electronic data capture, pharmacogenomics and biomarkers serving as surrogates for clinical endpoint are now providing new opportunities to reduce clinical testing times, and CROs have played their part in developing them, he noted.