The State of Clinical Development in 2023
Increasing Phase 2 clinical trial cancellations can have a long-drawn and multifold impact on clinical research
Gen Li, PhD, MBA, is the president and founder of Phesi Inc., a global provider of patient-centric data software and analytics. Li has extensive experience in clinical development, having previously worked at BMS, Pfizer, and Pharmacia, where he significantly contributed to the Centre for Medicines Research (CMR) International database for pharmaceutical R&D performance. His work inspired him to create Phesi—ensuring the insights held from historical data, or data collected from planned and current clinical trials, were not lost.
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Gen Li, PhD, MBA, is the president and founder of Phesi Inc., a global provider of patient-centric data software and analytics. Li has extensive experience in clinical development. His work inspired him to create Phesi—ensuring the insights held from historical data, or data collected from planned and current clinical trials, were not lost.
With the aftershocks of the COVID-19 pandemic still rumbling, conflict affecting much of the world, and the global economy in a state of disruption, Phesi was keen to investigate the state of clinical development in 2023. Our global analysis of all clinical trials conducted in 2023—comprising 65,749 recruiting trials—revealed some important findings.
Most-studied indications
For two consecutive years, the top five most-studied diseases with the most recruiting sites remained the same. However, the ranking of diseases changed, with COVID-19 trials dropping significantly. Breast cancer remained the most studied for the third year running, followed by solid tumors, stroke, COVID-19, and prostate cancer.
It is notable that three of the five most-studied disease areas are oncological. The increase in solid tumor trials is a positive sign for patients given these trials are likely to unlock innovative cancer therapies. Breast cancer remains a priority in clinical development; approximately one in eight women in the US will develop invasive breast cancer in their lifetime.
Courtesy: Phesi Inc.
Meanwhile, we’ve seen a marked reduction in investment into COVID-19 therapies in 2023, likely due to fewer available patients, and we expect this downward trend to continue. However, the impact of the pandemic is still felt in clinical development—for instance, in rising attrition rates.
Rising attrition rates
In 2022, our analysis revealed an increased attrition rate at Phase 2, which was no surprise given the pandemic’s repercussions. What’s concerning is that the problem persisted in 2023, with more than a quarter (28 percent) of clinical trials canceled when in Phase 2—surpassing the average attrition rate of 20 percent before 2020.
Such high attrition rates in Phase 2 slow the rate at which new therapies reach the market and will have an ongoing effect on clinical development, adding to rising costs. The knock-on effect is that Phase 3 cancellations will likely rise in the coming years.
Trial amendments are another issue causing costly delays for sponsors and trial planners. Phesi data show the average Phase 3 protocol experiences around 3.3 substantial amendments, each costing an average of $500,000 and cumulatively adding 5.2 months of implementation time.
Breakdown of global share in clinical trials
Our analysis revealed the US is home to over a third (33 percent) of the 115,000 recruiting investigator sites from interventional trials globally—with as many sites as the next top seven countries combined. However, the US’s share of all global clinical trials has been steadily declining, with countries like Japan and China now playing an important role in a more integrated clinical development industry.
Courtesy: Phesi Inc.
The war in Ukraine also significantly impacted global recruiting investigator sites. Compared to January 2020, Ukraine’s share has decreased from 1.4 to less than 0.3 percent. Meanwhile, the share of recruiting sites in Russia, previously one of the top ten countries, dropped from 2.9 to 0.5 percent.
Putting data in the driving seat
The clinical development industry must adopt a data-driven approach to withstand the impact of global disruption. This begins with using digital patient profiles or DPPs. DPPs provide a statistical view of patient attributes, allowing trial sponsors to create digital trial arms and drive greater innovation in development. Building digital twins bridges gaps in patient recruitment, increases patient centricity, and reduces unnecessary amendments—helping get therapies to patients faster.