CHICAGO—KMR Group, a leader in analyzing research and development performance data for the biopharmaceutical industry, reported in August that the duration of clinical trials continues to hold steady or increase, despite ongoing efforts by biopharmaceutical companies to reduce cycle times. Specifically, KMR assessed cycle time trends for more than 6,000 Phase 2/3 clinical trials using proprietary industry data across 27 companies going back to 2005. The analysis focused on clinical trials across all therapeutic areas.
KMR defines total cycle time as the interval from protocol approval to clinical trial report, and the analysis reportedly reveals that both Phase 2 and 3 trials have increased significantly over the last 10 years and continue to rise. Phase 3 trials took a median 35.7 months in 2005-2007 and 42.9 months in 2012-2014. Not only have industry median cycle times risen, KMR notes, but also when normalizing performance by company, the median change on a company basis also shows significant increases. Since the 2005-2007 period, cycle times have increased 16.4 percent in Phase 2 and 55.4 percent in Phase 3 on a per-company basis.
“One obvious question is why, despite efforts to reduce time, cycle times continue to rise,” KMR noted in observing these trends. “Only with this understanding can companies set actionable controls to help counteract this negative trend.
“We see the research environment shifting as regulators and payers demand more from companies to demonstrate safety, efficacy and cost effectiveness. The result of these shifts are increasing patient sample sizes, longer treatment times and more carefully observed adverse effects. Indeed, a major factor as to why cycle times have risen are increasing treatment times in the trial deign. However, even when accounting for treatment time, there is still a large increase in study duration over this time frame, indicating treatment alone is not the cause.”
Another dynamic brought on by these growing demands is the increased use of contract research organizations to offload some of the rising burden. That shift itself brings an entirely new set of challenges, such as how best to manage the CRO relationships, oversight, loss of operational control and quality concerns—and still keep costs low.
As the pharma and biotech industry evolves to a more patient-centric view and the investment in personalized medicine (such as biomarkers and companion diagnostics) and rare diseases becomes more important, KMR expects trial times to continue to increase—it also expects further demand from regulators to incorporate payer-specific endpoints in trial design, which will add complexity, cost and time.
Electronic data capture (EDC) systems have been one tool companies have used to reduce cycle times, and KMR notes that over the past decade, the use of EDC to reduce data capture times has had a positive impact for companies. But, as most companies have already transitioned to EDC in a majority of trials, KMR maintains that the next frontier in terms of reducing cycle times is in the study start-up and recruitment space.
“This encompasses an entire set of processes that can contribute to lengthy cycle times, such as country startup, site initiation and the performance of sites, as well as the specific countries companies are working in and how many,” KMR notes. “If companies focus on this area, they can achieve substantial reductions in trial time, but navigating the dynamic between major and emerging markets, site performance and size of study is a complex endeavor. Companies that maneuver this area with more dexterity will be able to achieve large improvements, but companies that are unable to meet the rising demand and challenging environment from regulators and payers will continue to fall behind the industry.”