Phesi, a company that offers artificial intelligence (AI) powered clinical development analytics and solutions, has released the results of its most recent analysis of clinical trials conducted around the world in 2021. The findings indicate that breast cancer was the most studied disease area, followed by COVID-19. Oncological diseases dominated the top five, with non-small cell lung cancer, solid tumors, and multiple myeloma rounding out the number.
Paul Chew, chief medical officer Phesi, remarked, “The fact that oncology takes four of the top five spots for most studied disease area underlines its status as the area still receiving the most investment – and it is good news for patients that even as the biggest public health crisis for 100 years is ongoing it is still taking the top spot. Breast cancer affects 2.2m people a year globally and is the second most common cancer in women in the US, making up about 30% of all new female cancers each year.”
Phesi’s analysis indicates that within breast cancer clinical development 25,000 investigator sites have been solely dedicated to recruiting patients since 2017, a trend that appears unaffected by COVID-19. This includes pharmaceutical and academic studies, and the same investigator sites involved in multiple trials; this means an average of up to 7,000 people are continually working on breast cancer clinical trials. According to Phesi, this trend is likely to continue, but it is costly and not sustainable.
Outsourcing-Pharma checked in with Gen Li, president and founder of Phesi, to discuss the analysis and what might lie ahead.
OSP: Could you share some of the reasons why Phesi conducted this analysis—how do you think this info might be of use to pharma firms and clinical researchers?
GL: We wanted to measure objectively whether the majority of research over the past year has been focused on addressing the current public health crisis and to see what other disease areas currently receive the most investment. More importantly, we also wanted to review whether this investment was channeled correctly.
The analysis underlines that most trial sponsors failed to leverage the true power of their data or ensure targeted business spending. Our analysis showed that only 14% of the 900 breast cancer trials were optimized, highlighting considerable room for improvement to ensure new treatments are delivered to patients as quickly and safely as possible. This is part of Phesi’s continuing effort to get an accurate pulse of global clinical development as an industry.
OSP: Were there any surprises?
GL: We were surprised to see the inclusion of solid tumors within the top five. However, it is really positive to see its inclusion and shows that innovation in oncology is continuing.
Solid tumors represent approximately 90% of adult cancers, yet many treatments like immunotherapy have proved less effective against solid tumors because it is difficult for immune cells to make their way efficiently into the core of solid tumors. Now we are seeing renewed focus and new breakthroughs in the space despite the challenges brought about by COVID-19.
OSP: You noted in your announcement that COVID-19 did not impact the trend of sites dedicated solely to recruiting these patients; were there any other areas that you did discern COVID-19 and the pandemic having an impact?
GL: COVID-19 dramatically impacted clinical development in 2020, with over 4,000 trials appearing in the space. While unsustainable, this was an understandable reaction to the crisis, however, our research and data since then show the industry bounced back with many trials in other disease areas resuming in late 2020. While COVID-19 is still impacting the world, sponsors have learned to adapt, which can be seen through the growth in trial sites in China after the virus had been relatively contained.
However, for many of the suspended trials, COVID-19 is likely to only have been a superficial trigger for a much deeper problem in the design and enrollment, given around a fifth of trials fail in ordinary circumstances. Most of the trials that failed during the pandemic were linked to intrinsic challenges in protocol design, rather than being directly caused by COVID-19. Adding an extra site can actually just exacerbate existing problems when decisions are not data-led, rather than solving them.
OSP: Is there anything you’d like to add?
GL: The industry launched over 4,000 COVID-19 clinical trials in a short period of two months. That was positive and necessary – it was an acute pandemic challenge facing humankind. Most of those trials failed, but we have harvested several effective and safe vaccines. Now we are learning to live with COVID-19, and our analysis revealed that together we are effectively making this important adjustment.
Phesi is exhibiting at this year's Summit for Clinical Ops Executives (SCOPE), taking place February 7-10 in Orlando, Florida, and online. The company also presented the session "Unlocking the Power of Integrated, Patient-Centric Data Science to Answer the Biggest Questions in Clinical Development," Tuesday, February 8 at 4:05 pm EST. For more information about the event, visit www.scopesummit.com.
