The size, complexity and geographical distribution of clinical trials can often lead to stock being left over, either at specific sites during the trial or overall following its conclusion. What to do with these pharmaceuticals can be something of a head-scratcher, but Durbin has the experience and know-how necessary to deal with this issue in as efficient and cost-effective manner as possible.
Running a clinical trial is expensive. In fact, studies have shown the average cost is estimated at roughly £24,000 per patient, and an estimated $10-billion-plus was spent on clinical trials in 2014 in the US alone. With this in mind, the pharmaceutical industry is increasingly asking questions about how to improve efficiency in clinical trials. One area of focus has been the reduction of excess stock.
Why do we have excess stock?
There are a multitude of reasons why biotechnology, CROs and pharmaceutical companies are left with excess stock during or after the completion of their clinical trial. Most often, this is caused by an oversupply of products. However, excess stock also occurs as a result of unexpected changes in the course of the clinical trial – pauses, relocations, extensions, or even early closure due to ethical or safety concerns. Whatever the reason, excess stock can be a burden, financially and logistically.
Using the leftovers
A variety of options are available to clinical trial organisers when faced with excess stock. Specialists such as Durbin, a global supplier and distributor of pharmaceuticals, offer comprehensive solutions using excess stock to the advantage of the trial organiser. However, prior to this, an assessment of the type of products and their route of supply must be made, as this can dictate the solutions available. For example, investigational drugs cannot be resold, and if comparator drugs are supplied direct from the manufacturer, permissions may be required for further use outside of the clinical trial. Overall, the solutions can be divided into five areas.
1. Redistribution
Due to the increasingly global nature of clinical trails, sites are often spread across many geographical locations, and excess stock may arise due to sponsor decisions to relocate mid-trial. Alternatively, staggered completion of trials may leave one location with excess stock. The redistribution of this stock offers an efficient solution, and companies like Durbin are able to offer comprehensive services with customised project management.
2. Resale of products
When possible, resale of products offers a cost-effective solution to excess stock. However, it can present difficult challenges and is not always possible if a product has a short expiry date, or is for a niche or small end market. However, specialist companies are able to use their large customer base to identify potential customers and seek out demand for these products from around the world.
3. Donation to charity
The donation of clinical trial products to charity is a great concept but requires expertise to assess the potential for stock to be used via this route, as this solution is only an option for certain product types. However, under the guidance of CEO Leslie Morgan OBE, Durbin has been coordinating pharmaceutical product donations to charity for decades – in fact, more than £22-million-worth of pharmaceuticals have been donated to global charities via Durbin.
4. Project management of destruction
Once products expire, destruction is the only option. To minimise further financial losses, it is important that this process is done as efficiently and cost-effectively as possible. Outsourcing this process can free up internal resources to focus on other aspects of the clinical trial and ensures a smooth destruction process.
5. Customised comparator supply
A well-organised and efficient supply chain can be the key to preventing excess stock. Specialist companies like Durbin offer a customised supply chain with the ability to hold purchased stock in storage facilities; shipments are made as and when the products are required in order to ensure maximum efficiency. This reduces consumption of storage at the trial site, and allows ease of resale or redistribution from a centralised location if required.
Using clinical trial leftovers offers a cost-effective solution that can help to reduce global pharmaceutical waste and improve clinical trial efficiency.
