When it comes to managing your clinical supply chain, how accurate is your forecast?
In the world of clinical trial supply, this is a concern many supply chain managers grapple with on daily basis. Ensuring a trial has all it needs in good measure - from the drug itself to all the necessary equipment - is critical to that trial's success.
Ultimately, everything boils down to having enough drugs that will support the study making sure none of it goes to waste. It's not about forecasting any number it has to be the right number.
"If you're a company that doesn't have a good forecasting system then I would suspect that's your challenge," said one supply chain expert, who spoke on condition of anonymity. "There are good products out there, but if you're not using them then it could well be that's your biggest challenge."
Additionally, for many involved in clinical trial supply, patient enrolment and site activation are crucial factors, as both are key drivers within the supply chain. Therefore, when managing your supply chain, it is vital companies have a good forecasting system in place and that they actively use it.
"If you look at your study design, that's fixed," the supply chain expert said. "There's not too much variation in that sense. So therefore, your variable demand drivers become site activation and enrolment."
In that regard, he said, it's important companies steer clear of overly ambitious projections. While it might be easy to project when you intend to start your trial, you cannot activate your site until you get country approval. Furthermore, the whole mindset of 'a year ago, it took me 13 months to get South Africa up and running, so I'm going to assume that's still the case', is a flawed outlook.
Whereas you might be confident about when you're going to get country approval (based on experiences in the past) it's crucial companies don't fall into the trap of complacency, as the door for just getting country approvals can swing widely.
For the CTS expert these are the main concerns for large pharmaceutical companies. Nevertheless, for the companies who aren't as far along in the development process, forecast accuracy is their chief concern.
"There are many smaller companies conducting clinical trials that struggle to afford a good forecasting product," he said. "That's when they're left to resort to excel. We were there a decade ago and it isn't an ideal forecasting system."
For the smaller-sized sponsors, working in an excel-frustrated environment, it's crucial they recognise the importance of getting to a better place. But there is a cost to it, measured not only in money, but in time and resources.
There are two ways to justify having a better forecasting system in place. One is to review your company's track record of missing doses. A second way is to look at all the drugs you threw away that could have been allocated to another trial. In this instance, there's an opportunity cost of allocating that drug to a trial where a drug will not be needed.
Going forward, it is vital the industry at large re-evaluate forecasting processes. Chances are companies, small, medium and large are over forecasting the demand for their trials and as a result, their overage is significant. Therefore, having an accurate forecasting system in place is crucial.