Beating other investors to an offer or getting ample time to support a clinical trial can yield big benefits and returns. The advantages from the financial perspective can be fairly evident but the gains from having plenty of time to plan, design and implement support functions for clinical supplies may not be so obvious. In this two part blog series, I will discuss the challenge of supporting clinical trials and the importance of early planning for clinical supplies.
One of the challenges that occurs time and time again is the study sponsor or lead principal investigator presents their protocol to you late in the development process and requests assistance and input on how to obtain, store, package, label and ship the clinical agents needed for the study. My standard answer when put into that situation is “I will do what I can to optimize the project but if you only give me 30 days to plan and execute you are going to get plain ideas that use off-the-shelf techniques and in-house technology.” That level of sophistication may get the job done for small, fairly simple protocols but clinical supply support done quickly at last minute for larger complex trials may lead to all sorts of potential errors.
It is almost impossible to allow the clinical supply support team to become part the protocol design process too early. The benefit of talking with clinical supply support representatives early in the protocol design is their input on label and packaging design that can be incorporated into the initial protocol design without going through several version changes if what the protocol team originally proposes either should not or cannot be accomplished. This input may lead to ease of use of the clinical agents by both the study clinicians and study subjects, increased patient compliance of study subjects and more efficient outer packaging for shipping.
These improvements may be achieved by the use of color coding on labels highlighting differences in drug strength or dosage times, multilingual patient instructions that are tailored to the study population, custom kit boxes with pre-printed patient instructions and kit container sizes that can be densely packed into outer shipping containers. All these changes can take significant time to design and go through the proof and acceptance process.
The minimum lead time to do a comprehensive job of clinical supply support would be 6 months. It is not foolish to involve the clinical agent support team anywhere from 12 to 18 months out before study start when doing a complex, multiple arm international trial. That will give the clinical supply support team ample time to use the latest technologies to create an innovative approach to package, label and ship clinical agents and any ancillary supplies.
Stay tuned for Part II of this blog series where I'll review three areas of clinical supply chain that can greatly benefit from early involvement from the support team in regards to design and protocol development. In the meantime, check out my case study Cooling Valley Fever: Unique Kits for a Unique Clinical Trial. It focuses on the challenges of designing complex kits and distributing them to clinical sites, and how customized soultions can support clinical trials.