According to the "Streamlining Clinical Trials” study, patient recruitment now takes around 23 per cent of the total clinical development time line and, more worryingly for the pharmaceutical industry, is continuing to increase.
Study author David Richardson explained that: "In the past, patient recruitment improvement has focused on making sponsors and trials more accessible and convenient for patients," adding that "more recently, companies have been deploying web-based recruitment, including informational trial websites."
He went on to say that while a web based recruitment approach may streamline the process it does not address the lack of patients and, he suggested, makes competition for patients between trial sites more likely, thereby exacerbating the problem.
In today’s ultra competitive pharmaceutical market, the ability to bring new products to market in the short possible time can be critical in determining both a product’s success and a developer’s prosperity.
While discovery and early phase work can be difficult to streamline, the manner in which clinical trials are conducted, and particular the time taken to enlist subjects, can have a dramatic impact on the time they take to complete.
According to the Tufts Centre for the Study of Drug Development, clinical trials now comprise 60 per cent of total development costs, up from 30 per cent in the 1980s.
While the emergence of genetic testing has made the patient selection process more effective, this very effectiveness can mean that fewer patients from a prospective patient group are likely to be deemed suitable for enrolment.
In addition, such modern genetic procedures take more time to complete than traditional screening measures and require more costly laboratory analysis to complete.