Ever wondered why some clinical trials get delayed even before patient recruitment begins?
One of the biggest culprits is inefficient comparator drug sourcing. Comparator sourcing seems quite straightforward, but it is often riddled with misconceptions. It’s very natural to believe that it’s just about “buying the drug,” but in reality, it is a complex yet critical process to clinical trial success.
Let’s break down the misconceptions that can be hurdles in the comparator sourcing journey.
Myth 1: Any distributor can supply comparator drugs.
Fact: Only licensed and compliant suppliers can provide comparator drugs with guaranteed quality, authenticity, and regulatory adherence. So, avoid using comparator drugs from unverified sources. Doing this can risk counterfeit or substandard products entering the trial.
Myth 2: Comparator sourcing is just about finding the cheapest option.
Fact: Sourcing a comparator drug at a reasonable price is always the goal of the CROs and other pharmaceutical companies. But this should not be achieved at the cost of compliance, traceability, and reliability. Investing in compliant sourcing can protect against trial delays, regulatory setbacks, and patient safety risks—costs that far outweigh minor savings.
Myth 3: All comparator drugs are readily available.
Fact: Many comparator or RLD drugs are subject to supply restrictions, regulatory barriers, and sometimes market limitations. RLD sourcing requires strategic planning, which can be streamlined by collaborating with experienced sourcing partners.
Myth 4: Global sourcing is just local sourcing with shipping.
Fact: Global sourcing deals with additional layers of complexity. These layers include import/export licenses, customs clearance, and cold chain management. It’s surely far more than moving boxes across borders, as it also requires a stringent check over quality and compliance.
Myth 5: Source comparator drugs when you need them.
Fact: We can source comparator drugs whenever we want, but is it of any use if it’s too late? Late planning can derail trial timelines, patient recruitment, and regulatory approvals. This strategic sourcing ensures availability when needed, avoiding costly delays.
Myth 6: Only originator brands should be used.
Fact: Generics and biosimilars are equally valid and approved alternatives to originator brands in many trials. These comparator drugs also provide a pricing advantage while maintaining clinical validity, depending on protocol requirements.
Myth 7: Cold chain only matters for vaccines.
Fact: It is true that cold chains are essential for preserving the vaccine’s efficacy. But many injectables, biologics, and sensitive formulations require strict cold chain control as well. Any temperature deviation for these products can compromise product integrity and trial results.
Myth 8: Direct-from-manufacturer is always better.
Fact: Manufacturers may not support clinical trials, especially for small volumes. Authorized comparator drug sourcing companies with strong networks often provide more flexibility and reliability.
Myth 9: One-time sourcing is enough.
Fact: For long-duration trials, one-time comparator drug sourcing might not be sufficient, as it requires resupply planning. Batch consistency is critical to ensure data accuracy and regulatory acceptance.
Myth 10: Comparator sourcing is just a procurement task.
Fact: Comparator sourcing definitely goes beyond the procurement task. It involves cross-functional collaboration between clinical operations, quality assurance, logistics, and regulatory teams. A specialized sourcing partner ensures seamless integration across these functions.
Conclusion
Comparator drug sourcing is more than a procurement task.It’s a strategic, highly regulated, and quality-driven process that directly impacts the success of clinical trials. By debunking these myths, sponsors and CROs can make informed decisions that protect clinical trial integrity and ensure timely execution.
If you’re looking for reliable comparator drug sourcing, our team can help you navigate supply complexities with compliance and efficiency.
Contact us today to discuss your comparator sourcing needs and ensure your trials move forward without delay.
FAQs
Why is comparator drug sourcing so critical in clinical trials?
Comparator drugs directly impact trial validity, regulatory approval, and patient safety. Poor sourcing can lead to counterfeit or substandard products, supply shortages, or regulatory non-compliance, which can delay or even invalidate a trial.
Can CROs or sponsors source comparator drugs directly from manufacturers?
Yes. CROs or sponsors can source comparator drugs directly from manufacturers. However, manufacturers may not support small-volume requests for clinical trials or provide ongoing resupply.
How early should comparator sourcing be planned?
Comparator drug sourcing should begin during the trial design phase. Lead times can range from weeks to several months, depending on product availability, import/export requirements, and cold chain needs. Early planning ensures an uninterrupted supply and avoids delays in trial initiation.
Are generics and biosimilars acceptable alternatives to originator brands in clinical trials?
Yes, if the trial protocol allows it. Generics and biosimilars are often approved substitutes, offering cost savings while maintaining clinical validity. Their use depends on therapeutic equivalence, regulatory guidance, and trial objectives.
