How To Prepare Your COA Licensing Process for Success: 5 Key Considerations

Most clinical trials - around 75% - face delays due to regulatory or licensing challenges. Clinical Outcome Assessment (COA) licensing is a critical yet often overlooked step in clinical trial planning. When mismanaged, it can lead to: 

• Regulatory submission failures 
• Missed study timelines & extended costs 
• Intellectual property (IP) violations 
• Compliance risks & legal complications 

Just a single oversight in COA licensing can cost sponsors millions and delay drug development by months or even years.

To help you avoid these pitfalls, we’ll take a look at five of the most critical areas around COA licensing, the mistakes that can happen, and some effective strategies for avoiding them. 

• Clinical trial managers struggling with COA licensing delays. 
• Regulatory affairs professionals ensuring compliance in clinical trials. 
• Procurement teams managing COA costs and licensing agreements. 
• Sponsors & CROs optimizing global study operations. 

How do Copyright Considerations Apply to Clinical Trials?

Many organizations fail to verify COA copyright ownership before using assessments in clinical trials. 

This can lead to: 

• Legal disputes and financial penalties from unauthorized use. 
• Trial disruptions due to sudden COA restriction 
• Regulatory non-compliance leading to submission rejections. 

How to Surpass Trial Copyright Challenges: 

• Verify copyright ownership before protocol submission. 
• Ensure all licensing agreements comply with regional regulations. 
• Engage COA licensing experts to prevent costly legal mistakes. 

Overall, verifying copyright ownership and ensuring compliance upfront is essential to avoid legal, regulatory, and operational setbacks in clinical trials. 

How Can Consultants Help with the Protocol Design Phase?

Licensing is often treated as a last-minute administrative task, but it should be a strategic priority from the start - especially when dealing with multilingual trials.

Some of the key challenges include:

• Selecting the wrong COAs, leading to protocol amendments and resubmissions.
• Missed submission deadlines due to unforeseen licensing requirements.
• Escalating trial costs from late-stage changes.

A COA Licensing Consultant Can Help:

• Obtain accurate COA identifications and prevent mix-ups.
• Assess available variations - ensure copyrighted, modified and patient-reported COAs align with study needs.
• Conduct a gap analysis to identify missing translations or versions that could cause delays.
• Evaluate key assessment parameters by verifying administration methods, recall periods, and questionnaire formats.

By considering these crucial parts of the protocol design phase, you can minimize unforeseen clinical trial delays and improve patient experience.

When Should You Start COA Licensing?

Many sponsors assume that licensing can be handled after protocol approval, only to face unexpected hurdles that can cause significant problems, including:

• COA developer response times, which can be months or years, delay study activation
• Limited translation availability forces modifications to protocols.
• Regulatory approvals are stalled due to missing permissions

Tips to Eliminate Licensing Timeline Hurdles:

• Securing licensing approvals before study initiation.
• Assessing developer timelines early to avoid last-minute delays.
• Verifying existing translations of trial content - missing languages can derail international trials.
• Pre-checking eCOA compatibility - not all assessments work on digital platforms.

Poor Communication with Copyright Holders

Sponsors often underestimate the complexity of negotiating licensing agreements with COA authors and licensors, leading to:

• Delays in execution from unclear communication.
• Unexpected costs and licensing restrictions.
• Compliance risks from misinterpreted agreement requirements.

Solutions for Effective COA Communication:

• Establish direct communication channels with licensors from the start.
• Clarify all licensing use requirements to avoid misunderstandings.
• Leverage a partner’s pre-existing relationships with COA developers to expedite approvals.

Clear, proactive communication and leveraging established relationships with licensors are key to avoiding delays, unexpected costs, and compliance risks in licensing agreements.

Why Systematically Track and Maintain Licensing Agreement Documents?

Maintaining clear and structured documentation of COA licensing agreements is crucial for compliance and risk management. Consequences of failing to accurately track these agreements include:

• Regulatory non-compliance from missing documentation.
• Legal disputes over unauthorized use.
• Trial disruptions due to unclear communication of licensing terms.

Solutions for Documentation Management Include:

• Implementing a structured licensing documentation system.
• Tracking all agreements, amendments, and communications in a centralized database.
• Using a compliance framework to ensure audit-ready documentation, as we do at Acolad.

Should I Consider a Partnership for COA and Multilingual Content Licensing?

Managing COA licensing and multilingual content needs can be complex, with many challenges we've already outlined that could impact study timelines and compliance. One option to navigate these complexities is partnering with a specialist provider. Such partnerships can offer advantages, including:

• Established relationships with global pharmaceutical companies and COA licensors, potentially streamlining negotiations.
• Expertise in COA licensing, compliance, and global study support to help mitigate risks.
• Proven processes designed to reduce delays and optimize timelines for study activation.