Over the course of the past few years, Clinical Outcome Assessments (COAs), also known as instruments, scales or questionnaires, have become essential elements of clinical trials. Indeed, assessing the impact of a disease and its treatment on patients’ quality of life can bring significant advantages to drug development and label claims. COAs can be used to collect the patient’s voice throughout almost the entire lifecycle of clinical trials, from phase 1 to post-approval studies.
The use of COAs must follow several scientific criteria. It is also critical to note that COAs are typically copyrighted material and therefore their use must also comply with copyright requirements. Indeed, the copyright requires that sponsors secure permission of use by obtaining a study-specific license to administer a COA in a clinical trial.
Copyright and permission of use through licenses
A license to use a COA is a contract signed by the party intending to use the COA for a specific scope and the licensing provider, which may grant several rights to the user, e.g.:
- Right to use the COA in a clinical trial
- Access to the official COA original version and existing validated language versions
- Permission to develop additional required versions (new translations and electronic versions)
- Access to the appropriate scoring method and interpretation guidance
- Permission to disseminate and publish study results in the scientific literature
It is important to note that despite holding a license, users cannot make any modifications of content and layout to the COA (in paper and/or electronic format) without the copyright holder’s approval.
Learn more on key considerations on copyright in our blog post: "Clinical Outcome Assessments' copyright: impacts on clinical trials and how to obtain permission for use".
Key steps of COA licensing
The licensing process can be divided into three main steps which should be carefully considered early in the study startup plan.
Firstly, the needs of the study team must be collected and precisely defined. Then, the operational process can start and the owners of the COAs can be contacted to request a license. Finally, once the license is signed, the COA can be used in the study it has been licensed for. This last part usually triggers activities for other parties involved in the COA management. Consequently, the licensing terms and requirements must be communicated to all parties involved in the use of the COAs.
Needs, COA identification
- Obtain complete list of scales, countries and languages required for the research project
- Confirm source scales’ versions to be acquired
- Complete gap analysis of available versions and translations
- Investigate requirements of COAs to be used for the study (electronic implementation, linguistic validation, rater training, etc.)
- Outreach and communication with authors/developers/ licensors
- Negotiate licensing and organize execution of agreements
- Ensure timely payment of any licensing fees
- Obtain official English source versions
- Obtain official available translations
- Obtain authorization to translate in missing languages
- Obtain scoring manuals/instructions
COA management, operational
- Initiate translation and linguistic validation for missing languages
- Ensure that copyrighted versions and validated translations are used
- Get approval of the original screenshots from relevant parties
- Distribute paper COAs to sites as needed
- Ensure COA content and layout are compliant (paper/electronic)
- Ensure COA use matches licensing terms (# of patients, schedule of events, translations, mode of administration)
Risks and common pitfalls faced with COA licensing
If not implemented correctly, the licensing process can have a substantial impact on the success of the project:
- Breach of intellectual property (infringement, legal action)
- Study delays (regulatory submissions, site initiation visits, first patient in)
- Protocol amendments (inability to collect all planned endpoints)
- Invalid results (use of incorrect versions)
Here are a few examples of the main pitfalls that can be encountered during the COA licensing process:
Needs, COA identification
- Missing or incorrect copyright holder contact
- Scattered information around the access of COA versions
- Various scenarios for licensing (e.g., paper vs eCOA)
- Lack of awareness of COA licensing
- Copyrighted versus public domain COA
- Unanticipated budget increases
Mitigation plan to ensure successful streamlined COA licensing
One unique COA licensing coordination plan
The COA licensing and management processes involve many stakeholders whose activities are linked to or dependent on the COA license being granted. The stakeholders can include the clinical team, data management, COA developer, licensing provider, copyright holder, translation provider, eCOA implementation experts and vendors.
To ensure streamlined COA licensing and management, practical and critical information from all the stakeholders should be gathered to build a unique coordination plan. This plan must consider the following:
- Central coordination by one project manager
- Roles and responsibilities (deliverables)
- Timelines at each stakeholder’s level and at the study level (clinical trial regulatory submission dates and the site initiation visits for each country)
- Risks and specific requirements
- Tracking and adjustments with all stakeholders through constant communication
Early COA assessment with the licensing provider
The licensing provider should be involved as early as possible in the study planning process to help identify and mitigate any potential risks to COA and/or eCOA implementation:
- What is the COA developer’s usual response time?
- What are their specific requirements?
- Which translations are already available or may prove challenging?
- Are there COAs that are challenging to electronically implement?
- Are there any past lessons learned to be leveraged from a COA repository?
Tips for protocol-compliant COA versions
- Obtain COA’s full name, not just the acronyms (same acronym might be used for different COAs)
- Be aware of the variety of available versions (public vs copyrighted, modified versions, caregiver vs patient version)
- Review COA information (schedule of events, bibliographic references, COA description)
- Consider patient population (age group, gender, etc.)
- Review number of items, mode of administration, recall period
- Ask for review copies (for reference, approval of the version with study protocol team)
To conclude, obtaining a license or permission to use a COA in all appropriate versions (translations, electronic format) involves several areas of expertise with dependencies that can impact the timeline of COA and/or eCOA implementation. Therefore, to identify and mitigate any potential risks upfront, it is critical to involve all relevant stakeholders in one unique coordination plan as early as possible in the study planning.
Watch our recent webinar to get more details on how to successfully navigate the COA licensing process.Watch the webinar recording