Commercial Comparators for Clinical Trials - How Government Policy Impacts Availability and Sourcing
Introduction
The world of clinical trials is complex and highly regulated. Commercial comparators for clinical trials are marketed drugs used as reference products in comparative studies. They play a vital role in evaluating the efficacy and safety of new therapeutic candidates. However, sourcing these comparators can be a logistical and regulatory challenge. Government policy plays a central role in shaping the landscape of comparator availability and access. They can influence not only trial timelines and costs but also the quality and reliability of outcomes.
Understanding Commercial Comparators for Clinical Trials
Before delving into the impact of policy, it’s important to understand what commercial comparators for clinical trials are. These are approved medications that are already available on the market. They are used in clinical trials as benchmarks against which investigational drugs are tested. Their inclusion is critical in establishing non-inferiority or superiority, particularly in Phase III trials or post-market surveillance studies.
Key Government Policy Influences
- Regulatory Frameworks and Importation Rules
One of the most direct ways governments influence comparator availability is through their national regulatory frameworks. Each country has its own rules regarding:
- Whether and how investigational sites can import commercial drugs
- The required documentation (e.g., certificates of analysis, GMP compliance)
- Customs clearance and labeling requirements
Strict regulations can lead to longer lead times and increased complexity in sourcing comparators, especially across borders. In countries with tight import restrictions or rigorous documentation requirements, delays are common, which can stall trial initiation and increase costs.
- Reimbursement and Pricing Controls
Governments that control drug pricing and reimbursement policies may limit the availability of certain commercial products. If a comparator is not reimbursed or priced in a way that makes it viable for regular use, its supply chain may shrink, making procurement for clinical trials more difficult. In some regions, price caps discourage manufacturers from continuing to distribute or even launch certain products, especially if they’re not profitable.
- Market Authorization and Licensing Policies
Availability of comparators is closely tied to whether a product is licensed in a specific country. If a comparator is not approved locally, sourcing it may involve parallel importation or special procurement agreements—both of which require government authorization. Policies around off-label use in trials or use of unlicensed drugs in research settings can vary widely and impact trial feasibility.
- IP Protections and Exclusivity Periods
Patent protections and exclusivity granted under government policies can also restrict comparator sourcing. For example, originator companies may use regulatory exclusivity to limit access to samples or prevent the use of their drugs in comparative studies, especially for biosimilars or generics. Some governments have started to intervene by requiring originator firms to provide samples for comparison, but this remains inconsistent across jurisdictions.
- Public Procurement Policies
In countries with centralized public procurement systems, the availability of certain comparators may be limited to government-approved vendors or tenders. Sponsors may need to navigate complex procurement rules or face long waiting periods to access these drugs, particularly if stockpiles are low or if demand is prioritized for public health use.
Impact on Trial Timelines and Strategy
As a result of these policies, sponsors often face significant delays or unexpected costs when trying to source commercial comparators for clinical trials. This has led to a trend of “global sourcing,” where trial sponsors procure comparators from countries with more favorable regulatory conditions. However, this can create challenges related to consistency of drug supply, temperature control during shipment, and regulatory documentation compatibility.
In response, many sponsors now engage specialized comparator sourcing partners or logistics providers who understand the intricacies of country-specific policies and can help navigate the procurement process.
Conclusion
Government policies profoundly affect the sourcing and availability of commercial comparators, with implications that ripple through trial planning, budgeting, and execution. As the demand for comparative studies increases, especially in the development of biosimilars and combination therapies, regulatory harmonization and greater transparency in government procurement and drug access policies will be key to ensuring timely and efficient clinical research.
For stakeholders in the clinical trial ecosystem, understanding these policy-driven constraints—and building flexibility into sourcing strategies—is no longer optional; it’s essential to trial success.
Further Reading
- Useful information can be found on the UK Government website via this link
- If you enjoyed the above article there are more in the series which you will find by clicking here.
- Titles include:
- What’s keeping clinical trial organiser’s up at night?
- Waste mitigation in clinical trials
- …and many more.
