Sourcing comparator drugs for Clinical Trials can be complicated. Even an experienced Procurement team can fall victim to unexpected complications. Having a good understanding of the market landscape will help reduce the risk of supply issues, and to develop plans to help mitigate against these.
All approaches have positives and negatives, and the strategy chosen is dictated by the needs of each trial. A good partner will be able to support multiple approaches and will collaborate with Sponsors to determine the best sourcing strategy for their trial. Provided of course the Sponsor is willing to share trial details with their partners, as opposed to just requesting a number of packs of comparator. Let’s touch on some of the positives and negatives of each approach.
Direct from the manufacturer
Positives
Negatives
Open Market Sourcing
Positives
Product can be sourced from the open market which can be easier to facilitate from multiple options.
Potential for shorter lead times – product may already be released and available in wholesaler inventories. However, for high-demand products, and those in short supply at the time of request, some products may be tightly controlled by their Manufacturer. The result of this could be that each wholesaler is given a quota, and can only order up to the limit of that quota in a given time period.
Potential for better pricing. Drug prices vary country-country as shown in the graph below. Open market sourcing gives Sponsors the ability to access comparators from lower cost markets. However, bear in mind that lower cost markets often have limited stocks, so we always recommend choosing a larger and potentially more expensive market as a back-up if seeking to include a low cost market as the main source for a trial.
Negatives
When sourcing from the open market, the most common approach we see is centralised sourcing, in which sourcing for the entire study is performed in a single market. This approach is especially common for trials in which comparator/comedications are going to be re-packaged and re-labelled. Centralised sourcing reduces the number of batches and expiry dates that need to be managed over the course of the trial, simplifying inventory and expiry date management. It can also reduce the risk of waste compared with local sourcing – for example, if product is sourced locally for a specific country, that then does not recruit any patients. Please be aware of the final bullet in the above list if adopting a centralized sourcing strategy globally!
We see local sourcing less frequently. This approach avoids the need to seek regulatory approval to use ‘foreign’ medicines in a trial. Also, if commercial packs are not going to be re-labelled, it can also avoid the need to translate patient information leaflets into local languages, should this be required. Finally, sourcing of small quantities from multiple markets may approve accessibility of products during shortages. However, sourcing from multiple markets can add complexity to downstream activities such as packaging (more batches of materials = more packaging operations, batch records, QA/QP release activities), inventory management, expiry date management and can generate waste is product is sourced from countries that do not recruit patients as anticipated.
Pharmacy Supply
Rather than ship comparator products or co-medications to clinical sites, Sponsors may ask that sites use their own inventory for patients, and reimburse sites for any product used. Alternatively, Sponsors may ask patients to collect commercial products from retail pharmacies, and either reimburse patients, or provide them with trial-specific ‘pharmacy cards’ to pay for medication.
Positives
Negatives
Hybrid approaches
We have seen these used to attempt to capitalise on the strengths of the above strategies – especially for large global clinical trial, and those spanning multiple years. For example, a Sponsor may wish to source directly from a manufacturer, but delivery timelines offered by the manufacturer could delay their desired start date for their trial. To allow their trial to start when planned, the Sponsor may source from the open market initially to support the trial ahead of Manufacturer-supplied inventory becoming available.
To conclude
As described above, there is no perfect sourcing solution that will meet the needs of all trials. Clinical trial supply companies, and sourcing specialists, work closely with Sponsors to match their sourcing strategy closely to the needs of a trial. Combining this with their knowledge of product availability and pricing in global markets can help Sponsors to achieve cost effective reliable supply. At the end of the day, these service providers do this every day across multiple sponsors and trial designs, so their continued business depends on doing this right. In most cases, developing a successful sourcing strategy goes beyond the simple purchasing activity it is often seen as.
About the author
Ian Ball is the Director of Procurement at RxSource. He joined the company over 4 years ago and has over 18 years of experience within the industry.
Connect with IanLast quarter alone, we were able to positively impact the lives of 44,500 patients. Our goal is to improve the lives of 10 million patients in 10 years. Contact us today to learn more about how we can work together to make a meaningful impact.
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