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Discovery & Development Clinical Trials

The World’s Most Studied Disease

In January, Phesi released the results of its 2022 analysis of the world’s most studied diseases. After analyzing more than 80,000 trial records, the results showed that breast cancer retains its position at the top of the list. COVID-19 studies took second spot ahead of prostate cancer (in third) and stroke (in fourth). We asked Phesi CEO Gen Li for his thoughts on why the battle against breast cancer remains so important.

What sociological factors are contributing to breast cancer position in research?

The main reason that breast cancer remains top of the most-studied research areas is that it continues to be one of the most common indications globally. The American Cancer Society predicts that around 298,000 new cases of invasive breast cancer will be diagnosed in women in 2023 in the US alone. It also predicts that around 44,000 women will die from breast cancer this year. With breast cancer being the second leading cause of cancer death in women, it’s unsurprising that it remains an area of high priority for the clinical development industry.

Which sociopolitical factors hinder such research?

A lack of diversity among patients being recruited for clinical trials continues to present a hurdle for successful clinical development – not only in breast cancer but also in other indications. An analysis we conducted last year revealed that 42 percent of US cancer trial cohorts do not include African American patients, and 48 percent have no Hispanic American patients. 

Without diversity in cancer research, the industry cannot ensure that treatments are effective for all. Black people have the highest death rate and shortest survival rate for cancer of any ethnic group in the US, making it all the more urgent that this population is represented in clinical research. To bridge the diversity gap, clinical development companies should use the wealth of available data to inform clinical trial design at the planning stage. Recruitment sites and patient demographics should be considered much earlier in the trial design and planning process, respectively. Sponsors can also create digital twins, which can fill gaps in patient cohorts. This approach collates real-world patient data from similar or identical trials using the same agent to accurately model comparator outcomes while accelerating development.

How is digital technology changing the research landscape? 

Digital technologies, such as AI and digital twins, have proven to be invaluable across the clinical development industry. In traditional clinical studies, patients are often unnecessarily exposed to a placebo or potentially an inferior comparator, both of which increase the burden on both patients and sites, presenting ethical challenges and/or requiring higher numbers of patients to complete trials.

With better access to data, the clinical development industry will be empowered to design smarter trials and develop faster cures. For instance, with real-world data, sponsors can create digital patient profiles to guide protocol/trial design, using digital twins to detect early signals in a blinded trial, and digital control arms/external control arms to reduce sample size or eliminate a control arm altogether. These technologies can drive faster innovation in clinical development.

What activities is Phesi currently involved in when it comes to breast cancer research?

We are committed to working with sponsors to help them develop treatments for breast cancer, and we will continue to analyze our database – which contains more than 60 million patient records – to monitor trends in breast cancer research and provide advice to sponsors. 

In 2022, we released a global analysis of 2,511,046 breast cancer patients from 4,674 investigator sites, which found that participants in breast cancer trials are getting younger. With awareness of trends like these, sponsors can adapt the way they design trials to cater to a new cohort of patients – for example, accounting for fertility concerns, which is a new element in a younger patient demographic. As we gain more precise answers about molecular markers in breast cancer drug development – as in many other areas of cancer drug development – clinical data science will become even more critical and not just a “nice to have.”

How realistic is a cure?

Certainly, the development of a cure for the disease would be a huge achievement for the industry. As we have shown, breast cancer is one of the most extensively studied diseases globally, with a total of 25,000 investigator sites recruiting for breast cancer clinical development. As such, research into the disease area is currently consuming a vast amount of resources; finding a cure for breast cancer would not only help many thousands of patients, but also enable sponsors to invest this time and money into research into other disease areas.

We have already made strides in understanding many subtypes of breast cancer. Additionally, better understanding of breast cancer at a molecular level has stimulated more specific treatments for some of the “hard-to-treat” subtypes of the disease. However, I don’t predict that we will find the “cure” for any kind of cancer by 2030, but it is safe to predict that we will have made significant progress by 2030 in breast cancer treatment.

How has the pandemic affected research activity for breast cancer?

As we enter the fourth year of the pandemic, further signs of damage to the clinical development industry are continuing to emerge. Our latest analysis of all trials conducted in 2022 (80,917 global trial records) finds the overall number of trials has decreased, and the attrition rate for all phase II clinical trials was 28–42 percent higher than the previous five-year average. This is the highest proportion of terminations we have seen at phase II in recent years, which serves as a warning sign for the clinical development industry. 

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About the Author
Rob Coker

Deputy Editor of The Medicine Maker

Following a Bachelor’s degree in English Literature and a Master’s in Creative Writing, I entered the world of publishing as a proofreader, working my way up to editor. The career so far has taken me to some amazing places, and I’m excited to see where I can go with Texere and The Medicine Maker.

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