Clinical trials are the quintessential project, being both complex and requiring project management skills and techniques to bring them to a successful close. The measure of a project success – delivering on time and with quality inside the proposed budget – are key requirements in the highly competitive environment in which pharmaceutical and CRO organizations operate, yet this benchmark is seldom achieved and increasingly further out of reach.
Studies show that at any given time about one-third of all clinical trials are behind schedule. These trials underperform due to operational failures; meaning, they’re behind schedule, over budget, or the data produced lacks the quality needed to support an approval. Perhaps the most disturbing fact is that cycle times associated with starting clinical trials have not changed in more than two decades, in fact they are getting slower, and the subsequent need for study rescue may increase the cost of trials by 20 percent or more. Nevertheless, are clinical trials operating on schedule, efficient?
Over the past decade the capitalized cost to develop an approved new drug has more than doubled, and although some have labeled this as publicized propaganda from pharmaceutical companies as government funding has continued to increase, one fact remains indisputable that study startup, the activities involved at the outset of clinical trials, remains highly inefficient and prone to bottlenecks and errors. Clinical trials that get off to a good start are more likely to execute well and finish on-time and on-budget – study startup is the Achilles heel of clinical trials.
With unrelenting pressures to rein in budgets and cycle times the application of project management techniques to study startup holds the key to optimizing operational efficiencies and compressing timelines.