Patient recruitment takes up a greater proportion of a clinical trial's timeline in the USA than any other aspect, according to new research from Cutting Edge Information.
In a new report entitled Clinical Operations: Accelerating Trials, Allocating Resources and Measuring Performance, the company says 29% of drug-development timelines are spent on recruiting and enrolling patients, nearly twice as much time as is spent on patient treatment.
The competition for patients, combined with pressures to bring drugs to market faster, is seen as a key reason pharmaceutical firms and CROs are increasing their activities in markets outside the USA, tapping into a wider pool of patients who often have not been exposed to previous drug treatments.
Other findings from the report include that clinical trial protocol amendments are a major source of time delays and expense for their trials. This problem can be particularly costly in Europe, where companies’ regulatory departments have to send protocol amendments to the European Medicines Agency (EMEA) and the regulatory bodies governing clinical trials in each of the countries in which studies are run.
“Not only do excessive study protocol amendments cost development organizations additional time and money, they also carry a substantial opportunity cost to other trial activities,” according to the report.
In some extreme cases reported by interviewed executives, trial teams draft new protocol amendments even before previous amendments have been approved by regulatory authorities.
Finding more efficient marketing campaigns and new ways of attracting patient populations will drive the time-saving push for most big drug makers, according to Cutting Edge. Utilising the most effective referral tools and media channels to obtain patients can help cut down on this time-consuming task and accelerate enrolment, it says, adding that many companies are looking more to web-based resources and third-party vendors to assist with patient recruitment.
“Pharmaceutical companies face a huge challenge in reducing the industry standard 25% patient dropout and non-compliance rate," said Jon Hess, research team leader at Cutting Edge Information.
"Innovative companies that discover ways to lower the dropout rate and better meet patient needs will lead the industry in cutting clinical trial costs by maintaining their enrolled patients."