Clinical trials face delays all too often. But in a competitive industry, where time-to-market is everything, keeping these delays to a minimum could be the difference between a market-leading product and one destined for the shadows. McKinsey calculates that a second-to-market product will have a 6% market share disadvantage ten years later, showing the long-lasting impact a delay could have.
A well-known culprit is patient recruitment, which is often slower than trial schedules anticipate. Securing adequate stock of comparator drugs is another tricky area where complications often result in expanded timelines. Pharmaceutical Technology spoke to Ian Hoban, business development director at Aposave, the pharmaceutical services division of Abacus Medicine, to find out what sponsors can do to avoid delays.
Don’t leave it too late
If you haven’t started developing a rigorous comparator sourcing strategy, but have already developed an initial patient recruitment strategy, it’s time to urgently address the gap. Often, sponsors leave it too close to the start of the trial to place their orders. Being hit with a longer-than-expected lead time or a customs-related hold up at this stage could be detrimental.
“If delays happen, there’s things you can do such as potentially source smaller quantities up front as a solution for the initial demand while you slowly build up the inventory for the large bulk of the trial,” says Hoban. “That can have a knock-on effect though; if you’re sourcing smaller quantities, they can have shorter expiry dates, meaning they’re at risk of not making it through to the end of the trial.”
A problem that’s even harder to solve is missing documentation. According to Hoban, some sponsors go wrong by focusing too greatly on getting a good deal regarding the acquisition cost of the comparator. If the product doesn’t come with the necessary documentation, it could cost you more in the long run.
“It can cause all sorts of delays down the line,” Hoban adds. “The documentation might be important in moving it from one market to another. The medicine’s usage in a global trial could be compromised by that missing data.”
Choosing the right market to source from is also key. While small markets may work well for early phase trials, increasing the volume to supply a late-phase trial could account for a significant portion of the total patient demand in that market. “You’re never going to be able to sustainably source those volumes in a small market. When doing a Phase III study, you need to look at bigger markets or go direct-to-manufacturer,” suggests Hoban.
Having completed a thorough initial sourcing plan at the early stage of your trial design, it’s critical to make sure it is regularly reviewed and challenged throughout the life of the project. The dynamic environment of pharmaceuticals often throws up a change of circumstances that makes what was previously achievable suddenly very difficult, if not impossible.
For instance, some medicines become harder to source over time as demand increases both from other trials and existing patient markets. Meanwhile, as products approach the end of their life cycle, the manufacturer’s loss of exclusivity strategy may cause previously available presentations to be phased out – something currently seen with Eylea vials, for example.
Working closely with your provider
Sponsors should work closely with their key supply partners to ensure they receive regular reviews of the market dynamics for the molecule in question, and that appropriate risk analysis and strategy adjustments are carried out.
For Aposave, having ongoing discussions with the client and providing them with the information they need to make well-informed, strategic decisions through the duration of the trial, is key. Behind this is the company’s market analytics tools, which enables Aposave to rapidly assess predictive insights, prices, next available batches, suppliers with access, and the markets where CoAs will be available.
In addition, Aposave’s parent company, Abacus Medicine, purchases significant quantities of key specialty medicines on an ongoing basis, providing Aposave with unrivalled access to a dynamic source of the medicines needed to keep trials on track. The combination of Aposave’s experience, procurement resources, and state-of-the-art analytics has created a unique clinical trials solution for the next generation of pharmaceutical products.
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