The substantial cost of clinical trials will be reduced a fraction after implementation of the EU’s updated regulations governing clinical trials. The Commission estimates an annual saving of €800 million (1,088 million euros, £643 million).
This is about 60% of the cost of taking a single pharmaceutical to market. The claim is estimated two years before the recommendations come into practice. The earliest date they will first apply is 28 May 2016.
To put this price ‘saving’ into context, a study by Cutting Edge Information found that 42% of Phase I trials run longer than planned, which compares with 31% of Phase II and 30% of Phase III trials. Each day the trial is postponed equates to losses in drug sales of up to $600,000 (440,000 euros, £357,000) for small products and up to $8 million (5.9 million euros, £4.8 million) for blockbusters. The costs of delays – which tend to carry on for months – are potentially a lot more than the savings expected from these updated regulations.
Possibly the largest factor behind clinical trial delays is slow, and insufficient, patient recruitment. A shortage of patients has been reported by CentreWatch to delay 70% of clinical trials between one and six months. A postponement in bringing a blockbuster to market of a single month could cost up to $240 million (177 million euros, £143 million).
In a news piece discussing this challenge, the Los Angeles Times quoted Dr E. Ray Dorsey, a neurologist at the University of Rochester Medical Center, who has studied the problem. Dr Ray Dorsey said: “It’s a major issue. Many trials are started and never finished because they can’t complete enrollment. A lot of money is wasted.”
However, the problem of recruitment appears to vary with geography. In a multi-national breast cancer trial that planned to recruit 3500 patients, the US arm began nine months after the other countries, with an expectation of recruiting 350 patients – 10% of the original target.
The purpose of this blog is to explore various challenges faced by clinical research organizations and clinical investigators in implementing clinical trials within reasonable timelines and at reasonable cost, and discuss strategies to overcome them.