As the industry struggles with declining productivity as evidenced by the decreased number of submitted New Drug Applications (NDAs) and approved New Molecular Entities (NMEs), Clinical Trial pharmaceutical management is examining every aspect of the R&D process to bring commercially attractive new drugs to market in a more timely fashion. The longest and most costly step in the entire process is late phase clinical research. The performance of investigators at clinical trial sites is a major issue for many involved in late phase development. TTC LLC and the University of the Sciences in Philadelphia (USP) are conducting an extensive, multi-year, global analysis of why some clinical trials finish faster and perform better than others do, including the operations of clinical sites.
Drug development organisations that understand and learn from the concerns of clinical investigators will be in a better position to design, and subsequently execute, quality clinical trials in a more rapid time frame. A mail and email survey of over 1,000 US investigators reveals that investigators’ operational concerns centre on financial management, drug safety reporting, and patient recruitment. These concerns are found in almost all types of active clinical sites and are not concentrated in one particular group or groups of clinical investigators. While investigator uneasiness with financial issues and patient recruitment may be what many would expect to see, their uneasiness with adverse event reporting is a potentially major issue.
Finance Matters Clinical Trial