Phesi: Long-term damage from COVID-19 movement restrictions on clinical development is becoming clearer
The company released the results of its global analysis of all clinical trials conducted last year.
In 2022, the attrition rate for Phase 2 clinical trials was 28% – 42% higher than the previous five-year average. This is the highest proportion of terminations at Phase II in recent years and is even higher than in 2020, where the COVID-19 pandemic caused unprecedented disruption.
The organization said these high levels of attrition at that stage of studies are likely to have an ongoing effect on the clinical development industry and may slow the rate at which new therapies reach market, or even prevent viable new therapies from ever reaching patients.
In providing some rationale for the increase in Phase 2 terminations Dr Gen Li, president, Phesi, told BioPharma-Reporter, that the development stems from a combination of operational reasons, with the main factor being the COVID-19 pandemic and its impact on the biopharmaceutical industry.
“As we enter the fourth year of tackling coronavirus, the long-term damage on clinical development is becoming clear. Movement restrictions to protect public health meant that it was very difficult to recruit patients for many clinical trials, which has contributed to a higher termination rate. Another factor is that the enrolment challenges caused by the pandemic may also have negatively impacted data quality and rendered statistical results inconclusive, causing further terminations.”
However, he also pointed out that the total number of clinical trials has decreased overall and, subsequently, the rate of terminations is higher.
“Phase 2 studies are considered critical trials, so our latest findings have presented reason for concern. The statistics represent hundreds of compounds with potential to discover a viable new therapy that have been brought to a halt, but more time and more data will be needed to understand the full picture.”
Phesi, he continued, hopes to see clinical trial sponsors adopt a data-driven and patient-centric approach to rescue delayed trials from abandonment, to design more relevant protocols, and ensure successful study outcomes for existing trials. “Otherwise, the financial burden on sponsors and cost to patients’ health will be huge.”
Applying predictive analytics in protocol design, simulating trials, and using digital patient profiles will accelerate clinical development to get therapies to patients faster, he said. Indication-specific predictive modelling will streamline trial design and improve identification of patient populations and site selection, by providing detailed information on historical trial performance at a country and/or investigator level, added Dr Li. With these data, sponsors can model trials to reduce amendments and unnecessary termination, said the Phesi lead.
Brest cancer most studied disease
The company’s report, which evaluated 80,917 trial records, reveals that breast cancer retained its position as the most-studied disease area, followed by COVID-19.
Breast cancer affects 2.2 million people a year globally. It is the second most common cancer in women in the US, making up about 30% of all new female cancers each year.
Three of the top five most-studied disease areas fell within oncology, with prostate cancer the third most-studied disease, solid tumors fourth, and stroke fifth. Both prostate cancer and stroke enter the top five in 2022, replacing non-small cell lung cancer and multiple myeloma in 2021, according to Phesi’s data.
However, while oncology remains an area of high investment in clinical development, last year saw widespread scale back of overall activity.
“With an increase in available vaccines and therapies, it is not surprising that the number of recruiting trials for COVID-19 therapies has fallen. However, the reduction in breast cancer trials is unexpected, with 113 fewer recruiting trials in 2022 compared with 2021,” added Dr Li.
