When it comes to implementing study-appropriate scales in clinical studies, sponsors often face challenges that can add unexpected time and costs. Ideally, study teams and scale management service providers should review all the scales required for a protocol several months in advance of study launch since each scale is different, and each copyright holder’s requirements will be different.
It is not uncommon for just one scale to take months to license. Add additional time to translate scale materials and implement electronically into an eCOA system, and it can delay study launch and affect the entire project’s ability to go live. In addition, consider whether scales are to be administered electronically or via paper. If a scale is not available in a copyright-holder approved electronic format, additional time is required to migrate and validate it for implementation in an eCOA solution.
External factors
Oftentimes, factors outside of anyone’s control can create a bottleneck in the startup process, such as copyright holder response time or inaccurate information. Plus, it is not always clear whether a scale is copyrighted or not – sponsors could receive conflicting information or will not receive enough information to understand the correct details. To give an example, Signant Health1 has experienced instances where a copyright holder informed them that a translation was available to acquire along with the license. However, when it came time to finalise the license, the translation was in fact not available.
Yet another challenge from copyright holders’ requirements can be mandated translation vendors and their processes, which limits Signant Health’s choices in terms of vendor selection and can also impact timelines.
Evolving requirements
Clinical outcome assessment (COA) requirements are constantly evolving, and it is crucial to stay updated with the latest and greatest information available. Copyright holders can transfer rights at any time, requirements from a previous study may not be the same when the sponsor wants to re-use the scale, or licensing fees can increase without warning, burdening the sponsor with unanticipated additional costs.
Copyright holders may even ask to review translations or screenshots of the sponsor’s COA which, if requested without advance notice, will further increase timelines.
License or scale amendments
Initial licensing is completed based on the information known at the start of a clinical study. Any change to that information, including an extension of ‘Last Patient Out’ or the addition of new countries, languages, and administrations necessitates an amendment that will require extra time to implement. Sometimes, a sponsor will request a change to copyrighted scales, which requires approvals and can lead to many time-consuming discussions between the sponsor, their scale management partner, and the copyright holder.
Obtaining additional approvals for amendments is further complicated when scales involve more than basic administration and include subject interviews and observations or supplemental components, such as stimuli books and manipulatives that need to be purchased. Other times, specific printing requirements or the process of navigating international publishers who have hard-copy-only scales can be another hurdle to overcome.
Sponsors and CROs can prepare to face these common scale management challenges in their clinical studies by developing a thorough understanding of scale licensing, translation, and implementation requirements for each protocol and building realistic timelines. Proper planning, expertise, and time are key to successful scale management2 and overall study outcomes. After all, even the best study design will have poor outcomes if scales are poorly implemented.
Working with a seasoned team with extensive COA and eCOA experience, relationships with copyright holders, and a deep understanding of the nuances of this process can circumvent the impact of oftentimes complex, cumbersome, and lengthy scale management process.
References:
1 Scale Management: Quality COAs to produce reliable results: https://www.signanthealth.com/solutions/scientific-clinical-consultant/smartsignals-advisory-scale-management/
2 Scale Management: Setting Up for Study Success: https://www.signanthealth.com/resources/scale-management-setting-up-for-study-success/
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