Does geographic expansion increase or reduce the risk of clinical trial failure?
Data recently published by Citeline suggests a correlation between trial success and expanding geography, particularly in emerging markets. As the number of trials continues to grow outside of the U.S. and Europe, this seems to be a promising strategy for improving trial success. But will adding new countries give you the confidence to say you’ve reduced your risk?
Look at the numbers and you’ll see geographic expansion is only one piece of the pie. An analysis of 5,000 terminated trials showed 30% of phase III study terminations are due to enrollment difficulties, making patient recruitment the leading cause of trial failure.
Given that nearly 80% of clinical trials fail to meet enrollment timelines, according to Cutting Edge Information, it is clear the challenge has less to do with patient availability in a given region than with our ability to accurately forecast what will be required to enroll them.
Companies begin trials with a false sense of what to expect. Trial enrollment forecasts are faulty and rarely are completed according to plan. Site feasibility often is inefficient, contributing to inaccurate estimates.
The problem is that the current approach relies heavily on an outmoded paper survey of investigators. Those who respond provide unverified, rough estimates and may be overly optimistic about their ability to enroll patients. Those who do not respond may have the more productive sites, but you’ll never know. In the end, 37% of sites under enroll, and 11% fail to enroll any patients at all, according to a 2013 Tufts CSDD Impact Report. We can do better than that.
For decades, industries such as energy, construction and aerospace—industries that undertake major projects of the same scale as global clinical trials—have relied on statistical analysis to forecast completion times with scientific accuracy. Drug developers should follow their lead.
Instead of taking self-reported investigator guesstimates at face value, sponsors should conduct rigorous feasibility assessments using real data to determine the probability of enrollment outcomes. Instead of waiting for sites to miss enrollment targets, consider interventions, such as patient recruitment marketing campaigns to improve on your baseline forecast. Instead of managing unrealistic timelines, revise your probability estimates so target dates and numbers are attainable outcomes, not hopeful ambitions.
A variety of global data sources are available for more accurate estimates regarding the availability of patients. Here are a few:
Before undertaking your next global clinical trial, ask yourself and your colleagues: Are we sure our forecasts are right? Have we statistically validated our risk? Are we planning for success, or have we set ourselves up for failure?
Matthew Howes is head of strategic services at inVentiv Digital + Innovation, the digital center of excellence for inVentiv Health. A leader in digital strategy, Matthew has provided the fuel for digital businesses visited by over 100 million people every month and generate billions of dollars in revenue every year.
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