A major global pandemic was not enough to stop surging rates of biopharma research and development, but trial productivity still remains below the long-term average.
That is according to a new report out by CRO analytics firm IQVIA, which found that funding for early- and late-stage R&D, as well as deals, jumped last year regardless of the pandemic, while aggregate R&D spend for the top 15 companies “reached a record high.”
It also found that, overall, clinical trial activity recovered from midyear 2020 to levels above 2019–even without factoring in COVID-19 trials, which clearly didn’t exist the year before. Total trials reached 4,686, more than 300 extra than 2019 and an 8% rise, with 985 in phase 3, 1,880 in midstage testing and 1,821 in phase 1.
But there is more complexity here: There was an increase in the clinical trial productivity index, i.e., the way IQVIA measures how these trials are doing, but in 2020 it found this was mostly due to an improvement in phase 3 trials, widening the gap with phase 1 trials, “which score significantly lower with this index.”
When it comes to midstage tests, trials “have consistently been above the overall index” as success rates have been trending up and durations have been trending down, “even as complexity has been rising in phase 2 as rising numbers of endpoints and eligibility criteria are attributes of these trials.”
Overall, however, productivity “remains below historic levels,” the report found, as success rates are below the long-term average. This is because the complexity of trials is generally increasing, as are study durations in many diseases, IQVIA’s authors note.
Looking at the pipeline of pharma, IQVIA saw that growth in the late-stage pipeline continued in 2020, bringing total expansion to 43% since 2015, as cancer drugs reached record-high numbers. Growth in the early-stage pipeline, including next-generation biotherapeutics, paused in 2020, however.
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The dismal lack of diversity in clinical trials also continued: 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 of only 3% in the past six years and “were under-representative 79% of the time from 2015 to 2020,” IQVIA said.
Persons of Asian descent are also estimated to comprise 6.5% of the U.S. population, but again, only in 2015 was the median above this threshold, and 52% of trials in the past six years that were used by the FDA to approve medicines had under-representative participation.
“The growth in research and development driven by new oncology drugs, new funding and strategic investments is a testament to the resilience and strength of the innovative, global biopharmaceutical industry,” said Murray Aitken, executive director of the IQVIA Institute for Human Data Science, in an accompanying release.
“Faced with significant disruptions and the need to reprioritize research and development, the global life sciences industry has demonstrated its ability to meet and even exceed expectations for new and better lifesaving therapies and vaccines.”