Have you been involved in a clinical trial where it seemed, at the last minute, you learned blinding was required for investigational medicinal product (IMP) and comparator drug product? I have, and it is challenging.
Blinding is the process of making the IMP and comparator drug/placebo appear identical, or as close to identical, as possible. The need for blinding is usually introduced in some Phase 1 and 2 trials but is most common in Phase 3. “Double Blinding”, where there is an IMP, a comparator product and a placebo, is more typical in smaller studies. Making two items appear identical can be challenging and when 3 products are involved, it can be very complex.
What are the risks when “blinding” is identified late in the clinical supply planning stage?
- If the comparator product has already been procured, it can impact how the IMP must be packaged.
- If this happens late in the clinical supply process, when some items have already been procured and/or engineered for the IMP packaging process, it introduces the possibility of waste, financial loss and extended lead times.
- If the timelines for first patient in are established and firm, it compresses the production window and may require using a less ideal solution.
When we know blinding is required early in the protocol development process, it places us in the best position to design the most effective solution for a clinical trial sponsor.
Key advantages to early identification of blinding requirements in a clinical study:
- Packaging complexity helps establish required production timeline. For example, syringe blinding is a much more advanced and complex process when compared to blistering or bottle fill and requires more lead time.
- Once the comparator and its packaging details are defined, an IMP packaging solution can be designed to match. The investment in upfront design delivers efficiency across the whole project.
- In the example of pre-filled syringes blinding, identifying the specific components within the comparator’s delivery device allows the required time to source equivalents e.g. plunger rods, plungers, backstops / finger flanges, etc.
- If a component is unique to the comparator, it provides sufficient time to engineer / develop the required components, such as injection molding for a plastic part.
How can you ensure the best blinding solution?
- There are advantages to working with packaging providers that blind across all formats e.g. solid doses, sterile injectables, inhalers etc. Innovation teams benefit from the experience gained across all forms.
- A global footprint optimizes flexibility for both the clinical supply provider as well as the Sponsors. This scale leads to sharing of best practices and, in some cases, availability of in-house 3D printing, custom technology and engineering design.
- Global sourcing on corporate-level global purchase agreements can provide cost-efficiencies for sourcing all components.
- Providers that can also source the comparator product on Sponsor’s behalf will be in the best position to design an optimal blinding solution. They will have the quickest insight to the specifics of comparator packaging in order to initiate a design process.
The end-to-end clinical supply chain begins at the earliest stages of drug development and continues post-commercial launch as products continue to be evaluated for other indications. Recent years have seen extensive consolidation within the clinical supply outsourcing market. Increasingly, pharmaceutical manufacturers have the option of creating single-source full-service providers who can provide visibility throughout the process. Regardless of how large or small the supply chain process is, early planning always leads to the best result.