Clinical trials take place across the globe to develop medications and treatments for a range of diseases.
However, challenges in developing new drugs have increased because of advanced technologies, increased regulatory requirements, and the complexity of clinical studies.
One important aspect of successful clinical studies is the effective sourcing of ancillary supplies, especially for complex researches that demand precise monitoring, detailed planning, and coordination between researchers.
What to Consider When Sourcing Comparator Drugs for Clinical Trials
Limitations on quantity, long approval timelines and procurement of product documentation are some of the biggest challenges facing comparator sourcing. Too often companies and individuals adopt a one-size-fits-all approach that causes operational, regulatory and financial risks, and eventually threatens the viability of their clinical trial results.
Here are some key factors to consider to minimize the time, cost and hurdles involved in comparator drug sourcing.
1. Find the Right Provider
It’s common for modern clinical trials to be carried out on more than one continent. Knowing which products are registered and available on different continents during trial planning is crucial to avoiding problems downstream. Once the required medical supplies for the trial have been finalized, start looking for an appropriate source or sources for the same. Although there’s a range of sources available for the comparator, regional variations in the drug in terms of dosage form and strength, API concentration, and looks make it important to explore all the available sources. Only those that are audited to ensure supply chain security and lower the risk of fake products should be considered.
The right provider should have a global supply network and provide timely and accurate assessments of where they are available, their costs and how long they’ll take to source. They can also provide guidance on how often to source and label, and where to store and distribute materials.
Always research and make arrangements for alternative sources for a comparator, in case there’s an unexpected change in production or formulation of the original source material. Instant access to alternative sources helps minimize the risk of failure or delay in delivering medical supplies to the trial sites.
It is also crucial to work with comparator sourcing companies that understand your study’s needs and are ready to sign contracts weeks (not months) before the start of your trial. One typically contracts clinical supply services four to six months before they’re actually needed. However, requirements may change, leading to changes in the original contract and making the original bid process meaningless. Start planning early but finalize the deal only a few weeks before the trial starts.
2. Determine the Qualification Process
Selecting and pre-qualifying suppliers is a good practice when executing a local sourcing strategy. This helps ensure sustainability of supply throughout the clinical study.
Direct manufacturer sourcing is almost always the preferred mode of supply because it’s the fastest and most transparent supply chain. However, this may not be possible or desirable at certain times for a number of reasons. Perhaps the manufacturer doesn’t supply products to certain countries, has no or limited stock available within the study timelines, or has some norms and restrictions that don’t work for you. A sponsor may also not want to inform a manufacturer about a competitive trial. Under such circumstances, you may have to turn to wholesalers and distributors to obtain comparator supplies.
It’s important to only work with suppliers who have undergone a rigorous qualification process. This should consist of various parts, from a physical audit to risk assessments of both the supplier and the country of sourcing. You should also look for their reputation and referrals, licenses, sourcing permits, capacity, pricing and benefits, economic status, and financial stability.
3. Package and Label Clinical Supplies as Required
Aside from playing an important role in the overall cost and budget of a clinical trial, its timeline can significantly facilitate or hinder the launch of a new medicine. With traditional packaging and labeling, typical lead time is eight weeks or longer. This requires project managers to monitor the process closely and make necessary changes.
Managers sometimes have to approve emergency processing fees to ensure timely delivery of clinical supplies. Being able to package and label clinical supplies as needed can significantly change the timeline strategy and its related costs. It can also accelerate the clinical study by shortening the period between protocol approval and first patient in.
4. Ensure Availability of Product Documentation
Documentation may be mandatory for import/export purposes and Regulatory Affairs to prepare CTAs. Obtaining documentation can be a substantial challenge, as this can differ by country. How a comparator is used in a study and where it is sourced from may impact the availability. With advance planning, it’s possible to locate and work with a comparator supplier that provides proper documentation. Starting late and/or choosing an unreliable supplier could lead to a late filing, a change in sourcing strategy, and a delayed clinical timeline. This, in turn, can cause costly delays, trial interruptions and flawed clinical trial results.
5. Optimize Your Logistics Strategy
Clinical studies run a high risk of inadequate logistics planning. This can not only increase overall costs but jeopardize the trial’s success.
So, it’s important to identify all the factors that can affect the supply chain. These include country-specific regulations and approvals, packaging and labeling, temperature-controlled storage, logistics, and developing a flexible and practical strategy to mitigate any potential risk. Improper logistics planning, for instance, can result in higher shipping costs.
To avoid this, increase visibility of the supply chain, implement an inventory tracking system, and adopt a distribution strategy that supplies products as needed at significantly reduced costs.
A clinical trial can fail or come to an abrupt halt if clinical supplies aren’t available throughout the trial process. This can affect research timelines and result in financial loss to the sponsor. Consider all the factors outlined here to eliminate complexities from your comparator sourcing process and reduce overall costs.