Standard of care (SoC) medications are often viewed as routine components of a clinical trial. In reality, they can be one of the most complex and critical elements of study planning. Whether used as a comparator, a required background therapy, or as part of a combination treatment regimen, SoC products require careful sourcing, documentation and supply management to ensure study continuity and data integrity.
For sponsors and clinical operations teams, leaving SoC planning until late in study development can create challenges that impact timelines, budgets and site MESM’s execution. In many cases, the availability and management of SoC products can be just as important to trial success as the investigational product itself.
What standard of care means in a clinical trial
Standard of care refers to the accepted medical treatment a patient would typically receive for their condition in routine clinical practice. Within clinical trials, SoC commonly appears in three ways:
- Comparator therapy, where the investigational product is evaluated against the current treatment standard.
- Background therapy, where participants continue receiving a protocol-defined standard treatment alongside the investigational product.
- Combination therapy, where the investigational product is administered in conjunction with an established treatment regimen.
Each scenario carries unique sourcing, documentation and supply considerations. Comparator products typically require a high level of planning, traceability and documentation to support regulatory and protocol requirements. Background and combination therapies may be supplied through central clinical trial supply models or sourced locally through approved site and pharmacy networks, depending on the study design and local regulations.
Selecting the right sourcing strategy is essential to ensuring product availability, supply continuity and operational efficiency throughout the study. Inadequate planning, documentation gaps or regional differences in product availability can create challenges that impact study timelines and execution.
Why standard of care is becoming more complex
As clinical trial designs evolve, particularly in oncology, standard of care is becoming increasingly challenging to manage.
Many modern oncology studies are built around combination approaches, adding investigational therapies to existing treatment regimens. At the same time, treatment standards continue to evolve rapidly, creating a moving target for sponsors designing global or multi-regional studies.
A therapy considered standard of care when a protocol is written may change during the life of a study as new treatments are approved and clinical practice evolves. This is particularly relevant in oncology, where treatment pathways are increasingly driven by biomarkers, combination regimens and rapidly changing standards of care.
For global studies, understanding these changes early is critical. What appears to be a straightforward protocol requirement can quickly become a sourcing, documentation and supply continuity challenge when studies span multiple countries and healthcare systems.
The regional complexity sponsors underestimate
What constitutes standard of care for a given condition is not universal. Treatment guidelines differ across jurisdictions. First-line therapies approved and reimbursed in Australia may not be the clinical standard in EU, USA or APAC markets including Japan, China, Singapore and South Korea. Dosing conventions vary. Branded versus generic availability varies. In some markets, the SoC product specified in a protocol may not be commercially available in the required form, strength or presentation.
This is one of the challenges addressed by ICH E17 in the context of multi-regional clinical trials. While treatment approaches should remain as consistent as possible across participating regions, differences in medical practice, product approvals and healthcare systems may require adaptation. These differences have direct implications for supply strategy and operational planning.
For sponsors running APAC studies, this often becomes a sourcing and documentation challenge. Depending on the study design and country requirements, products may need to be centrally sourced, imported under appropriate permits, supplied through approved local channels, or supported by additional documentation and labelling activities. Understanding these requirements early is essential to developing an efficient and compliant supply strategy.
The documentation requirements most teams miss
Protocol-defined SoC medications often require significant documentation and traceability, particularly when supplied centrally or across multiple countries. Depending on the supply model, documentation may include Certificates of Analysis (CoA), Certificates of Conformance (CoC), import and export permits, chain-of-custody records and other product-specific documentation.
A 2024 survey of Australian CROs and clinical trial sponsors identified availability, guarantee of supply, speed of sourcing and lead time as some of the most common challenges associated with clinical trial supplies, including standard-of-care medications. Documentation management ranked alongside product availability as a consistent pain point.
The common thread is that these challenges become more difficult to manage when they are addressed after protocol finalisation rather than during study planning.
When site-sourced SoC creates risk
The default assumption in many protocols is that SoC medications are available at site as part of routine clinical practice and can therefore be sourced locally. In many situations, this approach is appropriate and efficient. However, it is not without risk.
Site-sourced supply can introduce variability across sites in product presentations, manufacturers, batch numbers and documentation standards. For multi-site and multi-regional studies, these differences may require additional oversight to ensure consistency, traceability and protocol compliance.
Drug shortages can also affect SoC medications as readily as any other pharmaceutical product. Manufacturing constraints, regulatory actions, demand fluctuations and geopolitical factors can all influence availability. A shortage of a required therapy at a single site has the potential to delay enrolment even when every other activation requirement has been met.
For studies that require SoC administration prior to enrolment or as part of protocol-defined treatment, supply disruptions can directly impact patient recruitment and study timelines.
Three considerations that apply at study design
- Define the sourcing strategy early
- Establish whether SoC will be supplied centrally or sourced locally by sites and document the rationale. Central supply can improve consistency and control, while site sourcing may offer operational efficiencies when supported by appropriate oversight.
- Assess availability across participating countries
- Confirm that the specified product is commercially available in the required form, strength and presentation in each participating market. Where it is not, additional sourcing, importation or supply activities may be required.
- Understand documentation and regulatory requirements
- Import permits, export permits, product documentation and local regulatory requirements vary significantly across countries. Understanding these requirements during protocol development helps reduce downstream delays.
Practical steps for SoC supply planning
Bringing SoC considerations into protocol development rather than deferring them until site activation is one of the most effective ways to reduce supply risk.
At protocol design:
- Define the SoC requirement precisely, including product, dose, duration and role within the protocol.
- Map product availability across participating countries.
- Identify where central supply may be required.
- Evaluate documentation and regulatory requirements for each market.
At site activation:
- Confirm SoC supply arrangements before site activation or first patient enrolment.
- Establish minimum documentation standards for site-sourced products.
- Implement inventory monitoring and resupply processes where ongoing treatment is required.
SoC sourcing is a strategic supply consideration
Managing standard of care is not simply a procurement exercise. It requires an understanding of treatment landscapes, regional market dynamics, documentation requirements and long-term supply continuity.
As clinical trial designs become more complex and increasingly global, SoC planning is becoming a strategic component of clinical trial supply management. This is particularly true in oncology, where evolving treatment standards and combination therapy approaches continue to increase supply complexity.
For sponsors and CROs operating, differences in regulatory requirements, product availability and clinical practice can significantly influence study execution. Early engagement with an experienced clinical trial supply partner can help identify risks, evaluate sourcing strategies and support successful trial delivery.
Standard of care may not receive the same attention as the investigational product during protocol development, but its availability, documentation and supply strategy can have a significant impact on study execution. In today’s clinical trial environment, effective SoC planning is no longer an operational detail—it is a critical component of study success.
For more on sourcing comparator and standard-of-care products for clinical trials, see Top challenges sourcing pharmaceutical products for clinical trials.
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