Complex Clinical Trials
A recently completed analysis by the Tufts Center for the Study of Drug Development cites rising protocol complexity as a key factors that negatively impacts clinical trial performance and efficiency, while driving up the cost of developing new pharmaceuticals, reported Melissa Fassbender in Outsourcing Pharma. The situation could get even worse.
According to Ken Getz, associate professor and director of sponsored research at Tufts Center for the Study of Drug Development (CSDD), "Protocol design scope and complexity have steadily increased, and this trend will continue—and likely accelerate—as pharmaceutical and biotechnology companies target more difficult-to-treat and rare diseases, enroll more stratified patient populations, and collect higher volume and more diverse data.”
Getz explained that on top of increasing clinical costs and inefficiencies, current protocol design practices add to the burden on internal and external staff to execute trials and stymie study volunteer recruitment and retention rates. To perform the analysis, the researchers assessed 9,737 protocols from 178 global pharmaceutical and biotechnology companies.
Key findings stemming from the study, summarized in the July/August Tufts CSDD Impact Report, released in July, included the following: Phase I and II clinical trials are the most complex, based on numbers of distinct and total procedures, whereas Phase III trials have seen the highest increase in complexity during the past 10 years. The total number of endpoints rose 86 percent between 2001-05 and 2011-15, and procedures supporting these endpoints contributed a much higher proportion of data informing secondary supplementary, tertiary and exploratory endpoints. From 2001-05 to 2011-15, drug makers doubled the number of countries and increased the number of investigative sites by 63% to support Phase III protocols, as the mean number of patients declined 18 percent. During the next three years, companies expect electronic case report form data in the primary electronic data capture to decline as a share of all data collected to support protocol endpoints, highlighting the growing challenge of data coordination and integration.
In 2016, the Tufts Center for the Study of Drug Development, which is a multidisciplinary, academic research group that provides data-driven analyses and strategic insight to help developers, regulators, and policy makers improve the efficiency and productivity of pharmaceutical R&D, estimated average clinical trial costs across all three phases of development at roughly $340 million in out-of-pocket expenses, according to an article by Lisa LaMotta in Pharmadive. That study cited some of the tools that are optimizing clinical trials today: patient centricity, tapping into technology, wearable data, flexibility and automated site supplies.
“Big pharmas and small biotechs alike are looking for innovative ways to improve trial outcomes and, in turn, lower trial costs — this means increasing the efficiency in which they recruit patients, monitoring more closely how drugs are supplied and being more flexible about trial design,” LaMotta concluded.