The increasing complexity of clinical trials continues to vex drug developers, according to the Tufts Center for the Study of Drug Development
Tuesday, 15. May 2012
The new analysis, published in the report of May / June Tufts CSDD Impact, published recently, also found that:With capital and high cost of media, and the inherent complexity of the culture of mammalian cells, the proteins produced by mammalian cell culture are very expensive, they added. The bacterial production is generally more economical in terms of media components, but the bacteria are often inefficient to produce properly folded protein complex, requiring denaturation and renaturation step that adds significant costs for the production of bacterial proteins.
- The complexity and great variability exists in the protocol execution costs among the therapeutic areas and phases of clinical studies, which indicate the opportunity to simplify the design.
- The overall growth performance has increased complexity and slower spending rate for Phase III protocols, the companies that seek to contain costs, more data collected in the early stages of clinical research.
The study found that the average number of cases in clinical trials has increased by 49 percent between 2000-03 and 2004-07, while the total effort required to complete these procedures has increased by 54 percent.
- Between 2002 and 2007, the protocols targeted at diseases in oncology, immunology, central nervous system and has seen the fastest growth in the total number of procedures and responsibilities to carry out these procedures.
According to Getz, the greatest number of eligibility criteria used to screen volunteers has contributed to a decline in enrollment of volunteers in clinical trials.
And once you sign up volunteers, he said, the highest number of procedures per protocol study is discouraging volunteers to stay in the testing phase until the end.