“Experience is a series of places you’d rather not be” is one of my favourite phrases.

When planning a diagnostic development project, even seemingly benign decisions such as “How many diagnostic kits do I need to service my clinical trial in Brazil?” becomes REALLY important. It can be tempting to think, predicting kit numbers for our clinical trials is not that important right? Because we can just order some more kits when we have our clinical trial numbers figured out. But in the world of diagnostics here’s how that can play out…

The diagnostic manufacturer will have reagents that have a 6 week supply lead time. So asking for more kits means placing a larger order with the reagent supplier, who now informs you that the scale you have ordered means you need a larger batch HPLC purification method, which is not validated as part of the development of the diagnostic. Alternatively, you can split into 2 separate batches. Either way, you just added a 12 week delay to your clinical trial!
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It does not end there….. The larger kit numbers mean that you can’t fit all the kit boxes into a standard shipping box with dry ice. Which means you have to use a larger shipping box (or double the number of smaller shipping boxes). The diagnostic manufacturer can facilitate the larger shipping boxes but can’t accommodate the double numbers of smaller shipping boxes, at -80oC, out in Brazil. Unfortunately, the stability study only validated shipping of kits in the smaller shipping boxes. So now you can’t physically ship or store all the kits you need at your clinical trial centre in Brazil in time!
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Understanding the impact of seemingly minor decisions can have a huge impact on the success of your clinical trials and companion diagnostic developments. Working with an experienced partner who understands the importance of all decisions in the planning and management of a companion diagnostic, can significantly improve your chance of success.
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Jane Theaker, Director
(Jane.Theaker@DaTAGC.Solutions)