Clinical trial sourcing can be an arduous task for trial sponsors. Not only does a sponsor have to ensure that supply of the comparator product will be available for the duration of the trial, it also has to procure a product with maximum shelf life, and specific batch numbers, where possible.
To further complicate the process, more and more trial sponsors are now moving into emerging markets when conducting their clinical trials. This has made the clinical supply chain increasingly complex in nature, and the procurement of comparator drugs more challenging than ever before.
One way the industry could manage this challenge, and make the procurement process easier for trial sponsors, would be to encourage increased collaboration between trial sponsor companies and the comparator manufacturers/vendors.
However, comparator vendors, for the most part, have been greatly opposed to such a collaboration, and it is easy to see why.
A vendor that readily makes its product available to trial sponsors, will encourage the development of competitor products. With new drugs available on the market offering consumers increased choice, vendor sales will likely go down and prices will have to be cut if the vendor’s product is to remain competitive. Especially in the rare disease area, where certain companies monopolize the market for a particular disease type, this increased competition is particularly unappealing for vendors.
However, despite the obvious drawback for comparator vendors, a comparator consortium can still offer a number of benefits to companies involved. Collaborative networks can allow member companies to procure drugs directly from each other for their clinical trials. This can help provide companies with an adequate and timely supply of comparator products, thereby, reducing the challenges associated with comparator sourcing.
In addition, collaboration allows information to be shared between sponsors and manufacturers about which companies need which product and how much of the product is required. This information can then help comparator manufacturers more effectively develop supply chain forecasts, which can decrease the risk of supply chain disruption for a trial sponsor. It can also help prevent a trial sponsor from buying a surplus of drugs and creating a product shortage for any other companies wanting to purchase the drug.
It is true that the benefits mentioned above work mainly in the trial sponsors favor. However, collaboration can enable accelerated trial timelines which can increase patient safety. It can also promote the development of new drugs which can be used to treat seriously sick patients. It is clear, therefore, that collaboration can do good for the whole healthcare system, not just the developer of a new drug.