Comparator drug sourcing for global clinical trials can be a complex process, especially when trying to navigate it for the very first time. Generally, companies adopt a one-size-fits-all approach, but this can result in them being exposed to regulatory, financial and operational risks which, in turn, can threaten the integrity of their results.
Clinical trials are a complex process that touch on issues surrounding the financial, operational and organizational aspects of the required materials. As more trials are conducted around the world, it’s vital that the companies and individuals involved become aware of the process to figure out the best way to go about them.
A Guide to Comparator Sourcing
In this post we point out some basics to help companies understand what comparator sourcing is in order to navigate the process in the best way.
What is a comparator drug?
Generally, a comparator drug refers to an already licensed drug that is available in the market and is prescribed to patients. They are widely used in clinical trials to evaluate the effectiveness of a drug used for a particular treatment. Depending on the kind of clinical trial, a comparator can be used as an active control drug, either instead of or in combination with a placebo (an inactive drug).
What does comparator sourcing mean?
It’s the strategic operation for obtaining the materials to be used in clinical trials throughout the world. It includes a strong supply chain, forecast of operations, and the expertise required to ensure that proper logistical methods are followed.
However, recognising and approving such a broad network of sourcing to meet the increasing needs of the global trial market can be costly for investors and sponsors. As a result, many teams performing clinical trials need specialized support to ensure the sourcing is done effectively, especially in emerging markets. Many teams look to outsource the acquisition of materials to a third party who can offer better expertise and insights regarding the materials needed.
But this link in the supply chain isn’t completely free from risks which makes it vital to choose a reliable partner with a good reputation. An experienced professional will know how to work with a sponsor right from the beginning and create a strong and foolproof plan to source materials. They will also have contingency plans in place to ensure the supply chain’s integrity. Most significantly, they ensure patients receive the treatment for which they have enrolled.
What types of vendors are available?
Typically, there are three primary types of vendors available in the comparator sourcing market:
- 1. consortia/network
- 2. specialist comparator sourcing vendors
- 3. vendors for clinical trial supplies.
Most pharmaceutical companies can find affordable alternatives to attain products. Additionally, they can save even more by partnering with specialists and leveraging their relationships with vendors, suppliers and manufacturers which can come in handy when making bulk purchases. This reduces the risks that can result in supply delays. This is possible as experienced professionals are aware of manufacturing timelines and remain up to date on market trends which helps them remain unaffected by supply shortages. This in turn allows them to ensure that the investors are well-informed about possible threats and can make the right decisions. Additionally, pharmaceutical companies can use comparator networking platforms to source relevant products.
Are there any risks associated with comparator sourcing?
Considering comparator drugs on a global scale can pose several obstacles including delays in resupply, unsecured supply chains, and a failure to attain necessary documentation. But these challenges must be managed. When facing any of these obstacles, it’s vital for drug inventors to create a strategy consisting of two primary elements:
- 1. Developing demand plans that are driven by risks, allowing them to quickly adapt to changes in the comparator quantity; and
- 2. Being aware of global regulations that administrate sourcing.
Remember, without a proper strategy, the risks involved with comparator sourcing increase. When different teams or individuals are tasked with sourcing on short notice, suppliers or wholesalers need to be found quickly, which can be challenging. This might result in comparator drugs coming from supply lines that can’t guarantee timely delivery.
Alternatively, suppliers might not be able to offer a single batch. This might result in the investor or sponsor purchasing the products in multiple lots which could lead to inconsistencies through the trial. This poses a great operational challenge along with additional paperwork to address recalls and audits.
Other issues include wholesalers or suppliers who may not be compliant with regulations, along with the logistics needed to deliver the comparator to locations globally. They need to be aware of both export and import regulations for the countries they supply, along with handling criteria for different types of deliveries.
Clinical trials are essential to ensuring the development of new vaccines and therapeutics that allow drug manufacturers to ensure the efficiency and safety of new medicines. However, these trials are subject to regulations and are dependent on various factors including comparator sourcing and supply of materials. Hopefully, this post helps you choose a supplier who can ensure a steady supply of comparator drugs for clinical trials.