Labeling comparator supplies takes careful planning
Labeling comparator supplies may seem like a small step in the overall planning of your clinical trial, however, coordinating the label design in parallel to securing comparator drugs can often times be quite a challenge. While labeling comparator supplies is certainly not a new concept, in my 15+ years of clinical supplies labeling experience I have seen a rapid increase in requests for comparator labels within the past 5 years.
To ensure that designing the labels does not become a hindrance to the rest of the planning process, and to avoid delays in timelines for the study startup, here are some top tips to keep in mind for your future studies that include comparator drugs:
- Samples: I cannot stress enough the importance of receiving a physical sample. This will ensure proper sizing and fit of the label, as well as function as a demo for label application – especially in cases where information needs to be covered and/or remain visible. Be sure to plan ahead and order additional supplies (when available) so a physical sample can be sent to the label design team. If physical samples are unable to be ordered and sent, a technical drawing is the next best option provided that all measurements and dimensions of the component are clearly marked.
- Existing Information: Comparator drug components contain commercial information, directions, and in most cases a lot number and expiry date printed onto the component or commercial label. The question here is what can be covered on the supplies, and what has to remain visible? Some studies require that the entire component be covered with an over-label; while other studies need to have access to the information already printed on the component. Establishing up front what you can or cannot cover helps the label design and print production specialists determine the proper sizing, templates, and label materials to use for your clinical label.
- Commercial inserts: Are there existing inserts in the commercial carton? Will they remain in the carton after the inner component is labeled? It’s important to take into consideration the thickness of the existing insert, and make sure there is enough room for a labeled inner component to fit back into the carton or kit. For studies with multiple countries, keep in mind that a booklet label will add thickness to the inner component. If the insert needs to stay, then you may need to plan for an alternative kitting strategy.
- Change of drug manufacturer: Sometimes in the midst of planning a study, or even during the study itself, a decision is made to switch manufacturers of the comparator product. If this occurs after the proofing process you need to take into account that the current label design may not work on the new supplies. The best way to mitigate this is to have a sample of the new supplies sent to the labeling group to confirm the size and layout will still function as intended. Photos of the new lot being ordered can also be helpful, provided the exact measurements are sent along as well.
- Kickoff Meeting: With all of the factors above playing a part in the design of your clinical comparator label, it’s best to schedule a kick-off meeting with the labeling team and work together to put a strategy in place ahead of time. Taking the extra steps to plan up front will ensure that the end result is fit for the needs of your study.
By following these top tips, and working alongside the labeling experts at Clintrak Clinical Labeling Services, you can rest assured that your comparator label will be of the highest level of quality and accuracy with unrivaled industry turnaround times.