Phesi, a leading clinical development analytics company has today published the results of its mid-year analysis of clinical trials conducted globally in the first six months of 2024. The analysis of 66,935 clinical trials reveals that Covid-19 is no longer in the top five most studied indications, replaced by type 2 diabetes.
The top five most studied diseases are now breast cancer, solid tumour, stroke, prostate cancer and type 2 diabetes. With growing interest in GLP-1s to treat other conditions including obesity, there has been clear additional investment in this area. At the same time, oncology remains an area of high investment, with three of the top five most studied diseases being in oncology.
“Following the success of therapies like Ozempic, it’s no surprise that type 2 diabetes research is being prioritised by biopharmaceutical companies. But with complex conditions with several comorbidities – like Type 2 diabetes – sponsors looking to keep costs low and minimise protocol amendments will need to design protocols with higher degrees of precision. This starts by building a granular, comprehensive profile of the target patient,” said Dr Gen Li, President and Founder, Phesi. “This will be vital in turning the tide on increasing Phase II cancellation rates across all indications. The concern is that the almost a third of trials canceled at Phase II is becoming the new normal – driving up costs across the industry and delaying therapies from getting to market.”
Phesi’s analysis is the latest in its series of annual and half-yearly reports on the state of global clinical development. Phesi’s team analysed data from its Trial Accelerator platform, which contains data from more than 120 million patients in more than 400,000 cohorts. This most recent analysis found that the rise in Phase II study attrition first identified by Phesi in 2022 is continuing. So far in 2024, 32% of trials were terminated during Phase II – a 56% increase on pre-pandemic levels. High levels of cancellations at Phase II not only increase the costs of clinical development, but also have a knock-on effect on the rate at which new therapies reach patients.
“In the last two decades, medical advances have driven a shift towards precision medicine. Yet clinical development practices have struggled to adapt to more specific patient inclusion criteria and smaller patient pools. Trial design requires huge volumes of data to ensure participant selection matches the level of precision in the medicines being tested,” said Dr Li.
“Other complicating factors include the high number of investigators backing out from clinical trials post COVID-19, and new diversity requirements from regulators including the FDA – which exacerbate enrollment difficulties. The clinical development industry can turn the tide on rising attrition by beginning with the patient. By leveraging predictive analytics, sponsors can design protocols better aligned with the target patient population, and identify the best performing investigator sites with a higher level of precision.”