It’s Only a Little Ice: A Personal View with Companion Commentary

[摘要] First, parallels are drawn between the conduct of clinical trials and a few events in history that share a management style known as “top-down” management or a hierarchal decision-making process. The author suggests that this process isolates investigative sites from sponsors and contributes to the failure of clinical trials. Trial design, patient recruitment, site selection, the use of electronic data devices, and enrollment timelines are examined in greater detail. Suggestions for a more open or shared process are offered, with the belief that fewer trials might fail and fewer questions might remain in the case of those that do.

[学科分类] 精神健康和精神病学

[关键词] clinical trial;trial design;site selection;drug development