Turns out the COVID-19 pandemic wasn’t as tough as the clinical trials industry. “Despite significant societal disruptions…overall clinical trial activity rose 8% in 2020, the fourth consecutive year with an increase above 7%,” according to a new report from IQVIA.
Not surprisingly, given the pandemic’s arrival on U.S. shores in early 2020, monthly trial starts fell significantly in the first quarter last year, but recovered from mid-year to higher levels than in 2019 even without the COVID-19 trials, the report found.
Clinical trial patient population diversity remained a stubborn problem, the report said. For example:
- African Americans or races identified as Black account for 13.4% of the U.S. population, while the clinical trials used to approve new medicines had a median participation from them of only 3% in the past six years and were under-representative 79% of the time from 2015 to 2020.
- Persons of Asian descent are estimated to comprise 6.5% of the U.S. population, but only in 2015 was their median trial participation level above this threshold, and 52% of trials in the past six years that were used by the U.S. Food and Drug Administration to approve medicines had under-representative participation from them.
- Hispanic or Latino ethnicity is estimated at 16% of the U.S. population, and consistently the median participation in trials from this segment of the population is less than half that level, though patients may not always identify themselves as such.
Overall productivity in clinical trials stalled in 2020, the report found, noting, “Most diseases areas have been declining in clinical development productivity—a composite metric of success rates, clinical trial complexity, and trial duration—over the past decade, which embeds the challenges of achieving clinical results in well-satisfied traditional disease areas such as cardiovascular and endocrinology, as well as shifts in research priorities to more difficult areas such as oncology and rare diseases.”
The report also found:
- The increase in the clinical trial productivity index in 2020 was mostly due to an improvement in Phase III trials, widening the gap with Phase I trials, which score significantly lower with the IQVIA index.
- Phase II trials have consistently weighed in above the overall productivity index as success rates have been trending up and durations have been trending down, even as complexity has been rising in Phase II with rising numbers of endpoints and eligibility criteria being attributes of these trials.
Edited by Michael Causey