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Copyright Permissions for Use of Clinical Outcome Assessments in Clinical Trials

When and why to obtain authorization

How Does Copyright Apply to Clinical Trials and Investigations?

Clinical outcome assessments (“COAs”) are standardised questionnaires, assessments, and diaries that are completed by trial participants, their caregivers, or by clinicians during a clinical trial. COAs serve as important “instruments” for the collection of data which are used to support the evaluation of trial results, both in clinical trials of new medicines and clinical investigations of medical devices. Because COAs are literary and scientific works, they are usually protected by copyright and relevant intellectual property (IP) laws.

As per the World Intellectual Property Organization, the owner of copyright enjoys the inherent economic and moral intellectual property rights. That is, the former enables the copyright owner to make commercial gain from their work (such as through licensing) whilst the latter helps to safeguard their authorship as well as the integrity of the copyrighted work by prohibiting its modification without permission. In many nations’ laws, moral rights remain with individual authors even after the authors have transferred their economic rights.

The unauthorized use of copyright-protected works presents a risk of reputational and monetary damages to the individuals and companies that infringe copyright. To minimize this risk, trial sponsors wishing to use copyrighted COAs in their trials should obtain prior permission to do so from the respective copyright holders.

The licensing process may be managed either by the sponsor’s internal team or be outsourced by the sponsor to their partner CRO, eCOA technology provider, or translation vendor. Due to the variance in the licensing requirements among the licensors, the licensing process can be time-consuming and confusing. Let's look at some of the common questions about this process.

What Does a Licensing Agreement Typically Cover?

A licensing agreement is a formal contract between the parties to allow one party (“licensee”) the right to something that is owned or controlled by another party (“licensor”). This agreement sets out the general and special terms and conditions for the use of the copyrighted work in a trial. Typically, the licensing agreement would cover what is being licensed, which rights have been granted, which restrictions apply, licensing fees, confidentiality and IP protection, and any other provisions as would be agreed between the parties.

The licensing agreement would also include the required wording of copyright notices and references that need to be added to the trial-specific materials which are going to be based upon or include the elements of the copyrighted work. This information will need to be shared with the relevant stakeholders involved in the implementation of COAs in the trial.

Plan Ahead:

The extent to which the licensing terms and conditions may be negotiated varies across licensors. Disagreements over the wording of the licensing agreement may lead to prolonged discussions between the parties, and the delay in finalising the agreement may have a knock-on effect on other related trial activities. Initiate the licensing process early to minimize the likelihood of delays.

How are Licensing Fees Calculated?

The licensing fee structure and payment terms are determined by the licensors. The licensing fee will be calculated based on the information requested by the licensor and provided by the licensee. For example, the licensing fee may be calculated on a “per-use,” “per-protocol” or “per-language and given mode of administration,” basis or it may be charged as a fixed annual fee. Supplemental materials, such as administration manuals, scoring and data analysis guides, or training provided by the licensor may incur additional costs. Be sure to explicitly request these materials from the licensor if necessary.

Where an authorized distributor manages licensing on behalf of the copyright holder, additional royalty fees and administration fees may also apply. The final calculation will be determined based on the specifications of each individual permission request.

Plan Ahead:

A licensing agreement may contain a reporting requirement, whereby a licensee would be required to provide a licensor with a written report on the actual number of uses of the copyrighted work in the trial (for example, upon the expiry of the term of the licensing agreement or on an annual basis). Establish a process for reconciling this information throughout the course of the clinical trial so it is available when needed.

What Information is Needed to Set Up a Licensing Agreement?

Depending on the individual licensor’s requirements, various pieces of the trial-related information may need to be provided. Typically, such information includes the name of the trial sponsor, protocol number, study phase, therapeutic indication, projected start and end dates of the trial, and participating countries.

Many licensors have their own respective web pages which outline their requirements around the licensing procedure. However, not all the information may be easily accessible. In some cases, a formal permission request would be needed so that a licensor can evaluate it prior to releasing any specific details. In other cases, extensive information search and contacting various sources may be needed to identify the licensing requirements.

Plan Ahead:

Changes in the scope of a trial (for example, addition of new participating countries) may impact the permissions already in place and may require updating of the licensing agreements, including paying additional licensing fees. Clarify with the licensors how potential changes in licensing scope will need to be managed to facilitate swift processing of new permission requests pertaining to the existing licensing agreements.

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What is a Modification of the Copyrighted Work?

Trial sponsors may seek to modify the original copyrighted work to adapt it to the trial needs. Modifications are referred to as “derivative works”. Derivative works form part of the licensor’s IP and include any change of the original copyrighted work, for example, removal or reordering of the questionnaire items, changing the recall timeframe, changing administration instructions, integrating copyrighted works into proprietary technological systems, such as mobile apps and web portals.

Creating derivative works requires permission from a licensor. Even where modification has been permitted in principle, the licensor may ask to review the derivative work prior to giving it their final approval. This could be the case, for example, where a paper-based COA instrument is being adapted for electronic administration.

Plan Ahead:

Depending on the nature and extent of modification, a licensor may ask for certain qualitative and/or quantitative data to evaluate the modification prior to deciding whether or not to approve it. Likewise, there may be modifications which a licensor would be unlikely to accept from the outset. Engage with the licensor early on to discuss the suggested trial-specific modifications to the copyrighted work and to understand the associated requirements and limitations.

Is Permission Required to Translate?

Newly developed language versions that based on the work protected by copyright are considered derivate works. As such, their creation requires permission from a licensor. Some licensors exercise strict control over creating, updating, and distributing the approved translations, whereas others may transfer the full responsibility and oversight for the translation process to a licensee. Specific provisions attached to the management of translations would be documented in the licensing agreement. For example, such provisions may include the requirements to follow a specific translation and cultural adaptation methodology when creating new translations, to involve the licensor in the review of the translated content at the prespecified timepoints in the translation and/or electronic adaptation process, and to provide copies of the final translations/screenshots for the licensor’s records.

Plan Ahead:

Where existing approved translations have been created by the COA developer’s/licensor’s internal team, these translations may not always be accompanied by the associated certificates of translation (CoTs). Rather, a COA developer would provide documentation that describes the translation and publishing standards that had been followed in the creation of translations. Engage with the licensor early on to ascertain the availability of existing approved translations in the required languages and of corresponding CoTs. If CoTs might not be available, work with your Regulatory Affairs team to confirm the acceptability of the alternative certification documentation provided by the licensor and plan your next steps accordingly.

Partnering with an experienced language services provider is one of the best ways to ensure compliance with local and regional regulations. At Lionbridge, our experts are ready to support you from start to finish in any jurisdiction.

Disclaimer: The copyright and IP laws are complex and may vary considerably across the jurisdictions. The information provided above is for informational purposes only and does not constitute legal advice.

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Nataliya Volohov
Nataliya Volohov