Complex trials detrimental to time, cost & recruitment; study
Pharma and biotech companies are under pressure to quicken and streamline the development process but the changing nature of clinical trials hinders these goals, according to a report by the Tufts Center for the Study of Drug Development.
The study found that between 2000 and 2003 the median number of procedures per clinical trial increased by 49 per cent. Furthermore, the total effort needed to complete those procedures rose by 54 per cent from 2004 to 2007.
In January 2008 Tufts issued a similar report looking into the impact of protocol design on clinical trial performance. This found that studies were taking considerably longer but Tufts has now identified that rising complexity is not uniform across all trials, creating streamlining opportunities.
Notably, certain phases of development and therapeutic areas (TA) are adding more procedures than others. Tufts highlights protocols targeting diseases in oncology, immunology and the central nervous system as experiencing the most rapid increase in burden from 2002 to 2007.
Over the same period Phase II and IV trials experienced the greatest relative increase in complexity and execution burden. Phase III changed the least and Tufts attributes this to companies collecting more data in earlier phases in an attempt to contain costs.
Tufts believes the wide variability in complexity and burden across TA and developmental phases indicates there are targeted opportunities for biopharm firms to streamline design.
“Wide observed differences in complexity and execution burden by phase and TA indicate that pharmaceutical and biotechnology companies can target their efforts to improve protocol design and improve clinical trial operating performance”, said Ken Getz, senior research fellow at Tufts.
