As clinical supply managers, we are not here for the times when things are going well. We are here because change happens and things go wrong that impact the supply chain. We need to be able to see when change is coming and manage through that change.
In clinical trials, there are a lot of things that we have little control over. Start for instance with before FPI (first patient in). Say you have the perfect supply plan, good communication with your sites, and great drug supply coming down the line. So you think maybe it's a good time to set your sights on something else. Then wham! All of a sudden it's FPI and supply problems start hitting from out of nowhere. Or maybe you are two months into a study and enrollment is already out of control because shipments are off, a manufacturer is late, or labels didn't print right. These are the everyday kinds of things that can and do go wrong, which we have no control over.
Let's look at enrollment as another example. Say it is underperforming like when 25 patients are enrolled and you are supposed to have 200. Did anyone consider that country approvals were required before site enrollment could begin? Just one "small" delay like this can cause a domino effect on your entire study. Fortunately, predictive clinical supply planning technology puts threats like these on the radar.
6 Disasters that Can Be Averted Using Predictive Supply Planning
Predictive clinical supplies and optimization technology helps to spot potential problem areas before they hit the supply chain. Equipped with supporting data, supply managers are able to share important insights with the rest of the team early on. Data can alert the team about the kinds of things that can go wrong so that preparations can be made to address them ─ or ideally ─ avoid them in the first place. Here is a look at six of the biggest threats to the clinical supply chain and how predictive technology can keep hard-hitting impacts at bay.
Unrealistic Enrollment Projections
Have you ever experienced where site personnel have overstated when they will begin enrolling subjects and how many? It happens; enrollment is an area where people tend to get overly optimistic. One way to keep projections realistic is to maintain solid working relationships and communication. After all, the sites are a key driver in your drug supply. Regularly bring in actuals from your IVR and recalculate the numbers for a realistic view of your drug supply over time. Get monthly enrollment forecasts at the site level and keep an eye on when the last patient is in. You may discover that the actuals vary significantly from your supplies forecast. If that is the case, you need to understand why there is a difference and bridge the gap between the two.
Be careful about the assumptions you are making decisions on .Let me illustrate with a clinical supplies guy I know. It is early on in the planning and he's confident that there is enough (more than enough!) drug supply to meet study requirements and so he moves onto something else. Excellent - his study reaches 100% enrollment and he is feeling really comfortable. But then a few months in, he realizes that his drug supply is located in the wrong place — and worse — he discovers that it is somewhere in the world where it is unlikely he will get it back in time, if ever. So although things initially looked good, this supply manager failed to account for regional enrollment differences and his drug supply was not where it was needed. He was operating on incorrect assumptions.
Drug supply management gets tricky in so many ways, especially with things like dosing. Since people in Asia for instance tend to weigh less than in the US, doses may differ and your drug supply needs to reflect these kinds of variations. It is a similar scenario with pediatric studies: children start little but then they grow so the dose may need to be increased over time, affecting supplies planning.
Timing of Shipments
Another common pitfall is sending drug to the depot too early. Dispersing drug to the depot on Day 1 for example can result in having too much drug somewhere and if that happens to be in South Africa for instance, you are unlikely to get it back in time.
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Having worked in clinical supply chain management for more than 30 years, Buz Hillman, Associate Director at Janssen Pharmaceuticals, is responsible for developing, leading, and managing strategic improvement initiatives in clinical supply processes. He's taken innovative approaches to clinical supply forecasting and IWR data analyses, resulting in significant changes in the way clinical supplies are managed within the corporation. His efforts have been recognized with several prestigious innovation awards.Here are some key takeaways Buz shared with others tackling "Everyday Challenges of Clinical Supply from Johnson & Johnson", presented at BioClinica's 2014 European User Conference. Buz has also presented these challenges in a complimentary on demand webinar.
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My advice is to maintain an open dialogue with your clinical team. Begin the conversation based on realistic data from your predictive clinical supplies planning tool. BioClinica's Optimizer data is a goldmine and it has a dashboard that gives early warning signs. Mine that data to manage supplies more efficiently and cost-effectively. And make sure the clinical team knows what your job is: To keep sites supplied!
Focus Attention Where Needed
Get the schedules and data you need to stay informed. Use the data to get a decision on things that don't seem right. I honestly don't give much attention to what's right in my Optimizer dashboard that's because I'm focused on what is wrong so that it can be fixed.
Well I hope you picked up something from me here. Remember the big pharma companies are dealing with the same clinical supply situations as the small ones. Technology is available to support you in managing your supply chain to control costs and help keep studies on track.
Buz has used BioClinica's supplies Optimizer for five years at Janssen Pharmaceuticals. Today it's in use on approximately 200 ongoing clinical trials there.