No one has ever said that running clinical trials is easy. Rather, studies are arguably increasing in complexity due to ever-more sophisticated treatments, globalisation and the sharp rise in trends such as the boom in direct-to-patient (DtP) services.
Meanwhile, pressure continues to mount for new therapies to demonstrate better performance or safety profiles than existing treatments available. While this enables regulatory bodies to approve only the most effective therapies, there is also a moral incentive; providing sick patients with active drugs is a more ethical trial model than the use of placebos.
Efficient comparator sourcing is thus becoming an increasingly important component in a well-run clinical trial.
To secure this, many companies are drawing on the robust supply chains and expertise of clinical trials logistics suppliers. Such partnerships help them avoid delays and reduce costs, and the market for clinical supplies services is growing.
A report from MarketsandMarkets projects the market to reach $2.5bn by 2025, up from $1.7bn in 2020. This represents an annual growth rate of almost 8%.
The MarketsandMarkets report cites the main growth driver to be globalisation, which has increased the R&D expenditure of pharmaceutical companies. In addition, the rising popularity of biosimilars may be behind the particularly fast-growing comparator sourcing market.
Looking at GlobalData’s unique database of clinical trials, it is clear that there has been a steady increase in the number of trials that require comparator sourcing in order to operate effectively.
New and Ongoing Complexities in Comparator Sourcing
Clinical trial sourcing is often considered a complicated and expensive task. Against the usual constraints of tight timeframes, tight budgets, and competitors that are naturally tight with the supply of their own products, the goal is to secure a steady supply throughout the duration of the trial.
However, at the same time, the globalisation of clinical trials has complicated supply chains adding new layers of complexity around issues such as international trading and cross-border regulatory and availability hurdles.
And over the last year, there has been an extra level of difficulty with supply chain disruptions caused by the effects of the global pandemic, which intensified the challenges in securing a steady supply of any drug, therapy or treatment.
One other effect of Covid-19 has been a boom in DtP. While originally utilised as a way of reducing the visits patients on trials (who are often very sick and/or immunocompromised) have to make to trial sites, DtP has emerged out of the pandemic as a kind of new ‘normal’.
More studies than ever are now designed specifically as decentralised trials, using DtP services to deliver treatments. The use of DtP studies can help to lift some of the geographical barriers around recruiting in smaller patient populations, but at the same time it often adds increased complexity in clinical sourcing.
Other challenges are having an impact on the quality of supply. The shorter shelf lives of biologics puts pressure on supply chain management. A logistics partner able to guarantee custody of the cold chain is essential, especially with more fragile ingredients.
There is also the risk of counterfeit comparator drugs, which are on the rise. Ensuring consistent quality is a challenge when supply comes from different manufacturing batches. Moreover, rapidly changing serialisation regulations are being implemented to support the traceability of drug supply, and this requires local expertise.
It is also important to get available product documentation, such as a Certificate of Analysis (CoA), Material Safety Data Sheets (MSDSs), etc for quality compliance on all sourcing opportunities.
Sourcing Strategy Optimisation
Working with a clinical trials service provider that focuses on comparator sourcing is a smart move for trial organisers looking to reduce complexities and delays. With the right partner, cost-effective solutions can also be unlocked.
Oximio (previously The SMO Group) is a full-cycle logistics provider whose comparator sourcing strategies and services focus on cost-effective solutions and prompt deliveries.
The company identifies four key strategies a sponsor can take to reduce costs and drive savings.
- Direct sourcing
The first strategy involves sourcing directly from the pharmaceutical manufacturer. Purchasing directly can significantly reduce costs and lead to a long-term, consistent supply. Issues around counterfeiting are significantly reduced, as the products come directly from source and documentation about the origins of the product are secured via this approach. Companies can also be protected from the worst effects of open market pricing dynamics, and thus reducing the risk of huge price adjustments at the start of a trial. If this sounds ideal, it is worth noting that it can be extremely tricky to strike up this sort of collaborative relationship with a company likely to see you as competitor, who may not wish to support the development of another product. This is where strong industry relationships, via a third party such as a good comparator sourcing partner, can play a huge part in helping to land a deal. There is also, as a legacy of the last 12 months or so, a higher degree of collaboration across the pharmaceutical industry than ever before.
- Low-cost market sourcing
A second approach is to adopt a strategy of low-cost market sourcing, and while it can be strikingly effective, it requires all supporting documentation to be obtainable. But the advantages are considerable. In Russia for example, medicines are approximately 50% cheaper than in the US. Having such a strong local presence and network as part of a wider global group such as Oximio’s is a huge advantage in ensuring the knowledge required to deliver reliably and rapidly for all major markets. This is a great way to reduce costs, however it is important to factor in the cost of the shipment into the final pricing. In addition, Qualified Person (QP) releases may appear more complex.
- Generic alternatives
The use of generic alternatives is a third way to reduce cost relatively easily if there are suitable ones available. This strategy is widely used for standard-of-care rescue therapy sourcing and is usually handled at the local or regional level. Unfortunately, although understandably, generics are not always available for more innovative products. Moreover, in some countries the regulatory bodies in some countries may not accept a generic comparison of the investigational product. Yet again, strong and deep local market knowledge across a range of global markets is a huge asset.
- Market consolidation
Consolidated sourcing from a single-channel market can result in better supply management, stock and budget planning for a global clinical trial. It can also help to boost supply chain integrity and allow for a single point of distribution governance. This strategy requires rigorous supply planning and advanced stock reservation. As above, this requires very strong local presence in the relevant market. This also requires some degree of clarity around the dynamics of the trial. Changing patient recruitment patterns midway through a trial may create stock management issues. This strategy requires a clear and fixed trial plan so the required drug supply can be properly secured from the beginning.
Putting these strategies into action
For Oximio, developing the best sourcing strategy for each individual customer is always the core objective. This typically involves combining more than one of the above strategies to achieve the optimum cost optimisation.
The company’s depot network covers the UK, Eastern Europe, Western Asia, and South Africa, allowing it to tap into low-cost markets as part of its global sourcing strategy. But the ideal is to think clearly, to source the entire supply for a trial from a single source (such consolidation is what leads to the benefits of bulk purchasing and economies of scale), while at the same time making sure that single source is based in an extremely low-cost market, thus baking in these low costs for the whole trial.
From Russia with cost savings
Russia is a particularly cost-effective sourcing option, with access to a large amount of stock at very low prices. Under Russian law, documentation must be provided and having a local supplier able to accommodate this and who understands other local market issues, makes the whole process easier.
Oximio’s thorough understanding of the local market and detailed databases offer unique insights and real-time data on availability. Large stock can be purchased in single batches, with lead times averaging just 10 days. Oximio has strong network of manufacturers and vendors in the country, enabling economies of scale.
One recent example that demonstrates this in action was the central sourcing of Avastin® in Russia for a global multi-centre trial. In this instance purchasing the whole supply from this single, low-cost market made for an extremely cost-effective sourcing solution.
In this example and many others, Oximio’s Hungary depot can act as a centrally located one-stop-shop for sourcing and distribution for all regions. Meanwhile, the company’s bonded warehouse network allows for relabelling and redistribution once inbounded, with QP release to any global location.
The global supply chain in action
In another recent example, client required a supply of vaccine for a trial site in North Africa. Oximio was able to source from EU the total amount required for the client in a single batch. However, labelling service was still required.
This is where Oximio provided the additional solution. The team were able to source all necessary documentation (CoA, batch number, MSDS, PIL). The vaccines were then inbound into Oximio’s Georgia depot for relabelling and then distributed onward to the clients required end destination in North Africa. This was a clear end-to-end solution for the client which provided the product from source country to the final distribution site.
Comparator sourcing is becoming an increasingly important part of clinical trials, and the selection of a reliable comparator sourcing partner to deliver the necessary quantity of material at the right time is critical.
An essential element to successful trials is proactive planning; for comparator studies, this is imperative. Even with proper planning, issues such as resupply shortages and delays, gaps in supply chain security, inadequate product documentation and import/export challenges may still occur.
However, these risks can be mitigated with contingency planning, flexibility, good team communication, and retrospective debriefs (i.e. team learning from prior experiences). Navigating these with a well-selected clinical logistics partner is the key strategy for success of comparator clinical trials which if not planned and managed carefully could have significant impacts.
When it comes to delivery successful comparator sourcing logistics, there isn’t one suitable strategy that fits all situations, and Oximio ensures its bespoke strategies can cater to individual trial and sponsor requirements, in order to provide the most effective and robust solutions.