It’s a fact that ancillary supplies are frequently perceived as less important than study drug. Sponsors typically focus their attention on investigational drug, but may give short shrift to other supplies necessary for a clinical trial—the equipment, instruments and consumables that are collectively known as ancillaries.
While the focus on study drug is understandable, not paying ancillaries the attention they require can be a costly mistake. To understand why, let’s examine some common myths about ancillaries.
One of the most common mistakes made by sponsors is addressing ancillaries too late. This could mean that ancillaries fail to reach sites on time, delaying the start of studies. Planning for study drug and ancillaries should take place simultaneously, because they go hand in hand. Like study drug, ancillaries are subject to import/export challenges, translation needs, information delivery, and regulatory guidelines and timelines.
Many sponsors are under the mistaken impression that ancillaries are commodities and that sourcing them is as simple as placing an Amazon order. Thanks to the advent of precision medicine and patient-focused treatments, the volume and sophistication of ancillaries have grown. In addition to commonly used consumable goods whose supply has been limited due to COVID-19, ancillaries now include electronic items that may not be immediately available. Examples include eDiaries, iPhones, tablets, and wearable devices that go home with study patients, as well as specially programmed digital devices to track medication usage or make medication administration simpler.
Ancillaries aren’t optional; they are clinical trial must-haves. A study cannot begin unless both the investigational drug and ancillary components are available. Given the complex administration of many investigational drugs, one could argue that ancillaries play a more important role than ever before. No one benefits if sites have plenty of study drug, but lack the infusion pumps necessary for administering it, for example.
The budget for ancillaries can be anything but small. However, that budget can easily be overlooked when studies are outsourced or when sites purchase their own ancillaries – resulting in an unwelcome wallop to the overall study budget.
Budget considerations aside, the level of complexity involved in managing ancillaries can outstrip the resources of many sponsors, especially smaller companies. Sponsors would do well to choose a clinical supply service partner capable of handling distribution of both study drug and ancillaries. This limits the number of handoffs across the supply chain, while ensuring that drug and ancillaries reach sites so studies can start on time.
To learn more about ancillary management, please download the full article.