Clinical Trials Arena: What are some of the key operational challenges you face within the clinical supply chain?
Industry Expert: For those involved in the supply chain, I would say comparator sourcing and pooling supplies are probably the main challenges. Very often if recruitment is not as expected or approval of a site is not gained, then additional countries are added at a later stage, which logistically speaking can create many obstacles.
CTA: Would you say the latter is a bigger challenge rather than comparator sourcing?
IE: I think in some cases both of these issues come hand in hand with one another. The reasons behind these obstacles are manifold and vary from case to case. Sometimes it can be a regulatory issue and sometimes there are too many ongoing studies and the CRO might not be able to identify the right number of sites or the right number within a given country.
CTA: In your experience, what are the best ways of mitigating these problems?
IE: It boils down to ensuring you have ongoing dialogue with both the clinical teams and the CRO involved. My department sets clear expectations on recruitment forecasts and actual recruitment. One of the most difficult issues we deal with is when we either cannot buy the comparator that we want or we over recruit at a site where it takes three or four months to get the product over the border. That risks potential stock out, which of course means we won’t be able to treat ongoing patients. This is a recurring problem that’s tough to circumvent because you cannot control border and customs patrol.
CTA: Is that where the crux of the matter lies?
IE: Yes, as the regulations are unpredictable. On top of that, the regulations change constantly from country to country. So it’s difficult to navigate and that emphasises the importance of open dialogue with all the key players involved. You have to anticipate early enough if you see a rise in the number of patients or see a switch in regions so you can redirect your supplies to the right place.
CTA: So, open dialogue is vital in terms of mitigating any changing circumstances that may occur. What would you say are the key considerations trial sponsors should bear in mind in instances like these?
IE: It’s difficult to say because all trial sponsors should identify parameters that could impact any given study. It’s important to keep an open dialogue, be proactive, anticipate areas that are especially vulnerable, and identify whether you have available stock. If you have any weak spots, you have to be proactive and ask for the information to ensure operations are going ahead as planned and there aren’t any changes.
CTA: Could you give a real life example of when you faced this kind of scenario?
IE: One is when you’re recruiting in a specific region where there is a long import timeline, so you have to be really careful when putting together your projections for patients to predict any rise or fall in recruitment.