The Tufts Center for the Study of Drug Development (CSDD) at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. The role of CSDD is to conduct a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues.
Two years ago, Tufts CSDD conducted an analysis of clinical trials, which provided the first quantitative assessment of the impact of protocol design on clinical trial performance. In the May 2010 CSDD Impact Reports, the center announced the results of a follow up study, which found that the “growing clinical trial complexity continues to challenge the ability of pharmaceutical and biotechnology companies to contain the ever-rising cost of developing new drugs.”
According to their results page, the study found that the median number of procedures per clinical trial increased by 49% between 2000-03 and 2004-07, while the total effort required to complete those procedures grew by 54%.
Tufts CSDD Senior Research Fellow Ken Getz, who conducted the study, noted that “more complex and burdensome protocols are extending study cycle times, increasing costs, and challenging patient recruitment and retention.”
The study also found “wide observed differences in complexity and execution burden by phase and therapeutic area.” This finding indicated that “pharmaceutical and biotechnology companies can target their efforts to improve protocol design and improve clinical trial operating performance.”
According to Getz, “the rise in the number of eligibility criteria used to screen volunteers has contributed to a decline in volunteers enrolling in clinical trials.” Even when patients do enroll, another problem is that “the larger number of procedures per protocol is dissuading study volunteers from staying in trials through to completion.” Other findings included:
- Between 2002 and 2007, protocols targeting diseases in oncology, immunology, and the central nervous system saw the most rapid growth in the total number of procedures and in the burden to execute those procedures; and
- Overall growth in complexity and execution burden grew at the slowest rate for protocols in Phase III studies, as companies, looking to contain costs, gathered more data in early phases of clinical research.
The findings of this study reveal that more attention is needed to promote the participation of individuals in clinical trials. The results also indicate that new protocols and procedures—while designed for safety—have created significant problems.
As we previously noted, clinical trials are extremely important because they contribute invaluable information about the benefits and safety of existing therapies, providing doctors and patients with reliable information for choosing between alternative treatments. While the safety and integrity of all clinical trials must not be sacrificed, the growing complexity and execution burden must be addressed before research is hindered further, and patients are left waiting for medicines to be tested.