Dose-limiting toxicities… Tighter regulatory controls… Higher costs… Oncology comparator drug supply is challenging under the best conditions. Today’s increased focus on finding new cancer treatments continues to drive demand. At the same time, manufacturing and supply chain issues are causing shortages of many commonly used oncology drugs, making it critical to think strategically about standard-of-care comparators in your clinical trial. The right supply scheme can help keep the trial on track while reducing costs and waste.
Current oncology drug shortages
In the United States alone, the FDA Drug Shortages list includes nearly a dozen oncology drugs “currently in shortage,” including azacitidine, dacarbazine, floxuridine, fludarabine, and paclitaxel. A study on medicine shortages in the European Union found that “there has been a significant increase in the number of notified shortages within the last 5–10 years…” and that the categories most often affected were “pain relief medication, antihypertensives, anti-infectives and oncology medicines.”
A November 2022 article in Clinical Trials Arena notes that, according to GlobalData’s Clinical Trials Database, more than 4,000 ongoing oncology trials—28 percent of Phase III oncology trials and 19 percent of oncology Phase II trials—involved a drug on the FDA list. The author writes, “To plan ahead for possible shortages, experts say sponsors should think hard about sourcing strategies, weighing the advantages of localized and centralized sourcing based on their particular trial needs. In addition, improved drug waste management and back-up comparator options can all go a long way towards keeping clinical trials on track.”
Steps to consider:
1. Partner with a problem solver.
Every trial is different, and today’s oncology trials can be especially challenging. Pick a supply partner that has the experience, manufacturer and supplier relationships, and global resources to tailor solutions for any situation, including multiple medications and hard-to-source drugs, as well as complex regulatory requirements. Global reach and long-standing relationships can make it easier to access the hard-to-source drugs that your trial requires and can often provide cost advantages.