It Pays to be Proactive When Sourcing Oncology ComparatorsPosted on 02/28/23
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.
2. Involve your drug supply partner early in the process.
How early? It’s never too soon. When consulted prior to or early in the development process, your comparator supply partner can often provide input that results in a Clinical Trial Application that offers much greater flexibility should circumstances suddenly change. This might include potential back-up options to address shortages due to supply chain interruptions, other potential disrupters, such as new or changing regulations, or even in the event that a drug might be discontinued. It can be helpful to work with a partner that will assign an experienced project manager who can track key internal and external milestones and shift comparator sources as necessary to keep your trial on track.
3. Supply strategically to cut waste.
A successful supply strategy will help minimize the impact of any shortages while also reducing waste—a critical goal, considering the high cost of oncology drugs. Medicare’s 2020 data on drug waste lists seven oncology drugs among the top 10 drugs with the highest waste, totaling more than $300 million in losses. Although hard data is hard to come by, an expert cited in the Clinical Trials Arena article estimates that as much as half of the drugs supplied in oncology trials are wasted. Much of that waste is due to the challenges of trying to predict per-patient and per-site needs in advance—a task that is exceptionally difficult in oncology trials. Talk to your supply partner about just-in-time supply and other solutions to minimize waste.
4. Consider the source and ask the right questions.
Another consideration is whether to source centrally or locally—and the best choice for each unique situation requires weighing a number of factors. For example, European Medicines Agency approval does not necessarily mean that a drug is available in all European Union countries. The sourcing decision might depend on study timelines, quantities, available documentation, even the sponsor’s willingness to share study details. The most flexible overall strategy might be a supply scheme that offers the advantages of both. Myonex now offers innovative Clinical Trial Patient Solutions (CTPS) in North America and Europe that provide access through a pharmacy network or centralized pharmacy without the need for forecasting or bulk upfront orders, thereby eliminating overages and waste while also reducing the impact of potential shortages on the trial timeline. CTRx North America and CTRx Europe also provide local sourcing, compliant with local regulations, that gives patients convenient access, even to limited-distribution drugs. This approach can be particularly advantageous for trials with sites in the European Union, as some approved drugs cannot be sourced locally in all countries. The program can be combined with other Myonex services, such as Drug Sourcing, Equipment & Supplies and Packaging & Distribution, for a flexible, efficient end-to-end supply strategy.
If you’re running oncology clinical trials, get ahead of the obstacles posed by potential product shortages. Myonex has a team of clinical supply sourcing experts who are ready to help. Contact us today.