In Part I of this blog series, I identified some of the challenges in supporting clinical trials and a few reasons why early planning for clinical supplies is very important. In Part II, let’s look at three areas of clinical supply support that can greatly benefit from having the support team involved from the start and given ample time to design and contribute to the protocol:
Clinical Supply Labeling: Single panel labels applied at room temperature can be designed and proofed fairly easily using standard components. It’s when you start adding complexities to the equation that the length of time from concept to final proof acceptance can grow exponentially. Examples of this are labels that need to operate in extreme temperatures that need label stock and adhesives that will perform in those temperature ranges, i.e., vapor phase liquid nitrogen so labels will remain intact and securely in place after application, multi-panel tear off labels, booklet type labels and labels that incorporate multiple color print and fonts. Labels can be provided in bulk meaning all the labels are the same or they can become individually unique labels due to the addition of vial numbers, kit numbers or subject IDs. In addition, many international clinical studies require clinical agent labels that are written in several languages. The more complex the label the more time it takes to design the label itself, find and source unique label components and go through the review and critique process from the stakeholders to the final proof stage. You then have to actually manufacture the labels.
Clinical Supply Kits and Packaging: Kits can be as simple as a box or bag surrounding a group of like objects, i.e., syringes or applicators and can expand up to kits that contain many different components used in multiple steps, a good example are blood or specimen collection kits. Recently we had a protocol that incorporated a “start up” kit that contained multiples of 28 different components. Due to the final large volume of materials, we designed and had manufactured a custom container with movable dividers so the clinical sites could arrange the components in a way that each site desired. This is an example of innovative packaging that can assist the clinical staff in the performance of the study. This can only happen if the clinical supply support group is given ample time to design and manufacture containers and other items that are unique to a protocol.
Complex protocols that require the over-encapsulation of clinical agents, bingo card type bubble compartment cards (to facilitate better patient compliance) and the formulation of matching placebos can add significant time to the already busy schedule leading to implementation of the study. The sooner the protocol team involves the clinical supply support group the faster innovative solutions can be researched, finalized and incorporated into the final protocol design.
Cold Chain Compliance Packaging: With advances in medical science some of the current clinical agents being used in clinical trials have much more stringent storage and transportation requirements than ever before. Gone are the days of store in a cool, dry place only to be replaced with store at 2-8 °C or store between -15 to -22 °C ONLY. The new biological agents arising from stem cell research and the field of personalized medicine may have even more rigorous storage and shipping requirements, some with tight or no temperature excursions during transit. The temperature sensitive characteristics of these newer agents coupled with the increased focus on cold chain management by regulatory agencies make the packaging of these agents more of a challenge than ever before. Pre-certified shipping containers, utilizing phase change materials, may be adequate for smaller domestic studies as they can typically maintain the required temperature range for 1 or 3 days, well within the time needed to ship agents coast to coast. Large international studies having clinical sites located on different continents pose larger challenges. The logistic timelines may be much longer than 2-3 days from repository to the final destination and the shipments may cross several international borders (each with its own detailed inspection) and use several modes of transport. This situation may require the clinical supply support team to design and certify custom packaging to successfully reach these long distance sites. The design and certification of such a container may require the team to use outside resources for assistance, particularly the certification portion. All this takes time for prototype to final configuration.
In conclusion there are many things that go into a successfully designed clinical study. One source of assistance may be the clinical supply support team. The sooner you can get them involved the better the overall quality of the study will be. Give them the time to analyze the protocol’s needs and to create innovative solutions to the study’s unique needs.
Interested in learning more about managing the distribution of clinical agents for large, multi-site clinical trials? Download our eBook Protecting Your Protocol: Operating a Flawless Clinical Agent Repository. It discusses the process of how clinical agents are received, filling orders for clinical pharmacies, and ultimately how to minimize risk through the patient bedside so that you spot disasters before they happen.