BOSTON —While consumers probably won’t feel the pain, the increasing complexity of clinical trials will make it harder for pharmaceutical and biotechnology companies to keep the costs of developing new drugs under control, according to a new study.
The study, conducted by the Tufts University Center for the Study of Drug Development, found that the median number of medical procedures conducted per clinical trial increased by 49% between 2000 and 2003 and between 2004 and 2007, while the total effort put into the procedures increased by 54%. The study is an update to one conducted two years ago that the CSDD said provided the first quantitative assessment of the effects of protocol design, meaning the planning of trials’ methodology, on clinical trial performance.
The most rapid growth in the number of medical procedures and burden to execute them between 2002 and 2007 occurred in trials of drugs for cancer, autoimmune disorders and central nervous system disorders—areas that many big drug makers have sought to target as they transition into the manufacturing of high-cost specialty drugs. At the same time, growth in complexity and execution burden saw the slowest growth in late-stage, phase-3 trials, due to companies’ looking to contain costs by gathering more data in phase-1 and phase-2 trials.
“More complex and burdensome protocols are extending study cycle times, increasing costs and challenging patient recruitment and retention,” Tufts CSDD senior research fellow and lead study author Ken Getz said. “Wide observed differences in complexity and execution burden by phase and therapeutic area indicate that pharmaceutical and biotechnology companies can target their efforts to improve protocol design and improve clinical trial operating performance.”
Getz said an increase in the number of criteria for eligibility to partake in studies resulted in a decline in volunteers enrolling in trials, and once they did enroll, the larger number of medical procedures for each protocol dissuaded them from staying in trials to the end.
Therapeutic area with the greatest complexity and work burden for phase-2 protocols, 2002-2007
|Therapeutic area||Total procedures (median)||Growth in total procedures||Investigative work site burden (median units)||Growth in work burden|