If you went to the grocery store with only a mental list of items, it would cost you more time and money in the moment. Additionally, you’d probably buy some groceries that will spoil before you use them and others that will sit on your shelf for months. Another hidden cost is the one or two trips back to the supermarket to exchange or purchase the specific ingredients necessary for a recipe you are planning to cook.
The same is true for clinical ancillary management. As therapeutics become more complex, the supplies required in the protocols for clinical trials have extended beyond typical scientific products. Historically, ancillaries required in a study have been small---perhaps a few required items for drug administration. While that still may be true for some studies, today more complex ones might request 50 unique items. Sourcing, packaging and storage for equipment ranging from needles, bandages and tubes to freezers, ECG machines, laptops and nutritional supplements can be overwhelming. It might become even more complicated when you factor in the requirements of local, regional and global sites.
Similar to our shopping list, a standard checklist would be impossible due to a multitude of variables. However, here are some suggestions that will help you manage clinical ancillaries more effectively by planning ahead.
One common pitfall is thinking about your supplies generically, which ultimately will add time, resources and costs to your project. For instance, if you need syringes, you might ask:
- how will they be used?
- what are you injecting?
- who is administering the drug (patient or medical professional)?
- what adjunct product(s) might be required?
- is there a size, thickness or dosage consideration?
Once you have your rough draft, share it with the planning team and amend the list based on their recommendations. One of your colleagues might know steps in the protocol that require specific supplies you hadn’t considered. Although this process seems cumbersome, a thoughtful, collaborative approach will pay off in time, money and resource savings.
Unlike traditional supplies, it can be challenging to determine how many ancillaries are purchased at a time to avoid expiration or wastage. These items are not necessarily measured in individual units multiplied by the number of sites/patients. Additionally, each item on your list might need individual consideration. Just like our groceries example, you can’t afford to have supplies expiring, missing or sitting on shelves too long.
Now that you are prepared, consider how you’ve purchased standard products in the past. Some locations and vendors may be routine, but new supplies might require sourcing new distribution options. Engaging experts to evaluate your needs, preferences and budget requirements simplifies the decision-making process. However, the more you know about trends in clinical ancillaries, the more effective your supply chain team will be in managing clinical trials.