The Future of Oncology Clinical Research: Trends and Innovations
Part 1 of 5: The Journey So Far: Significant Strides in the Fight Against Cancer
By Pratik Reddy, MPH , Mazen Nuwayhid , and Peng (Kate) G.
Cancer is one of the leading causes of death globally. The World Health Organization (WHO) estimates that in 2019, cancer was the first or second leading cause of death before the age of 70 in 112 of 183 countries studied [1]. Despite these alarming numbers, there has been significant progress against cancer over the past 30 years. Globally, the age-standardized cancer death rate has decreased by 15% (from 147.93 deaths per 100,000 people in 1990 to 125.41 deaths per 100,000 people in 2019) [2]. Within the United States (U.S.), the rate of improvement is marginally better, declining by 19% over this period (168.98 deaths per 100,000 people in 1990 to 137.37 per 100,000 people in 2019) [2]. Such progress is also reflected in the decrease in Disability-Adjusted Life Years (DALYs), which accounts for years of life lost due to premature death and years lived with the disease. Over the same 30-year span, DALYs lost across all cancer types fell by 18% in the U.S. (4,242 DALYs lost per 100,000 people in 1990 to 3,229 DALYs lost per 100,000 people in 2019) [3]. Globally, the age-standardized cancer DALY loss fell by 20% (3,824 DALYs per 100,000 people in 1990 to 3,062 DALYs per 100,000 people in 2019) [3].
The global decline in age-standardized cancer death rates and DALY loss has coincided with clinical advances and increased availability of novel therapeutics such as targeted therapies, immunotherapies, and gene and cell therapies that provide patients with new and effective treatment options [4]. Thanks to the substantial and ongoing investment in drug research and development (R&D), oncology has become an increasingly productive area of clinical research. Between 2002 and 2021, 215 novel active substances (NASs) for oncology were launched globally and the rate has been trending upward – the average annual number of NAS launches for oncology increased from about 5 between 2007-2011 to around 11 between 2012-2016 to approximately 21 from 2017-2021 [4]. Oncology also represents a greater share of new drug approvals, growing from 12% of all drug approvals between 2000-2008 to 18% between 2009 to 2017 [5]. As recently as 2022, 30% of new drug approvals were intended to treat cancer [6].
Looking ahead, in 2022 there were 2,331 investigational oncology products with an active research program, representing 38% of all drugs in the R&D pipeline [7]. Clinical research will continue to play a critical role in translating scientific advances into innovative medicines that provide meaningful therapeutic benefits to cancer patients. Advanced therapies, however, often require more sophisticated clinical research with associated economic and logistical implications. The growing trends of decentralized trial design and increased use of digital technologies in clinical trials have the potential to help address some of these cost concerns. Today, to maximize the return on limited resources, drug developers must consider the potential application of emerging artificial intelligence (AI) technologies which may help optimize clinical trial design, facilitate patient recruitment, improve operational efficiency, and enhance data analysis. The lack of diversity and representation across race and ethnicity, age, gender, and socioeconomic status has been a major and enduring challenge facing oncology clinical research, and addressing this requires concerted efforts from researchers and research institutions, drug developers, regulatory agencies, policymakers, healthcare providers, community organizations, and patients and advocacy groups.??
In the next four installments of the blog series, we investigate and expand upon these four mega-trends influencing the oncology clinical trial landscape: complexity and cost of drug development, the integration of digital and decentralized trial methodologies, the application of AI, and the imperative to enhance diversity and representation among clinical trial participants. Drawing on historical examples, related literature, and industry reports, we aim to provide the broader context of the forces shaping these trends as well as their implications for the evolving oncology drug development landscape.
References
[1] Sung, H. et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin 71, 209-249, doi:10.3322/caac.21660 (2021).
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[5]?Batta, A., Kalra, B. S. & Khirasaria, R. Trends in FDA drug approvals over last 2 decades: An observational study. J Family Med Prim Care 9, 105-114, doi:10.4103/jfmpc.jfmpc_578_19 (2020).
[6]?Al-Madhagi, H. A. FDA-approved drugs in 2022: A brief outline. Saudi Pharm J 31, 401-409, doi:10.1016/j.jsps.2023.01.007 (2023).