While recent improvement in clinical trial enrollment levels in cancer may seem modest, there are notable advancements moving the needle in expanding the pool of potential participants, as our May issue explores.
Oncology clinical trials have always been a unique area in the R&D landscape. One of their greatest and longest-standing challenges has been enrollment. The number of patients participating in clinical studies for cancer, when compared to overall levels, has always been heavily lopsided to the low end—and even further so when you measure minority patient populations specifically. However, change could be on the way. According to a recent study published by the Journal of Clinical Oncology, which reviewed data from the 1,200 Commission on Cancer programs, the overall estimated patient participation rate in cancer treatment trials was 7.1% during the period 2013-2017, which was higher than historical estimates of <5%.
While the improvement seems marginal, what are some of the advancements moving the needle in perhaps expanding the pool of potential participants in oncology studies? To that end, our May issue of Applied Clinical Trials examines what the future landscape of oncology R&D could look like.
Leading off our coverage is a look at the scientific advances and emerging modalities that are pacing drug development efforts in cancer. Following that is an article on harnessing the potential of kinase inhibitors (KIs) for future advances in cancer. According to the authors, more than 50 KIs have been approved by the FDA to treat 20 types of cancer. Notably, with KIs, physiologically-based pharmacokinetic modeling is used for first-in-human pharmacokinetic predictions early in the discovery process, and for informing inclusion/exclusion criteria for the clinical trial protocol. This model can be employed if a sponsor is considering combining its KI drug candidate with another small molecule, to manage comedications, and create virtual cancer patient populations to evaluate compounds.
Wrapping up our May feature articles is an overview of the FDA’s recently released guidance in support of Project Optimus, which is a dosing-reform program established by the agency's Oncology Center of Excellence. Since the FDA announced the initiative in 2021, the industry has responded with a wave of technological advancements, especially driven by artificial intelligence. With Project Optimus, the authors note that the FDA has taken a clear position of shifting away from traditional chemotherapy and promoting more progressive tailored approaches.
Again, while recent increases in cancer trial enrollment seem minimal at the moment, with the innovations showcased in this issue of ACT (also check out our "In Focus" dive into the complex playing field for oncology trials), plus the many more out there, I am confident the industry is on the right path toward bringing cancer patients life-changing therapies faster and more efficiently than ever before.
As always, thank you for reading.
Mike Hennessy Jr is president and CEO of MJH Life Sciences®
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Novel Agent Shows Superiority Over Placebo in Reducing Monthly Migraine Days
September 5th 2024Lu AG09222 shows promise as first-in-class medication that prevents neurogenic inflammation, vasodilation, and parasympathetic lacrimation, which are considered to be surrogate markers of migraine attacks.