Part 1 – Clinical Outcomes Assessments: Mastering Copyright Permissions for Clinical Trials

Over a period of 5 years or so, I monitored the time management numbers on this – on our end, and on the Sponsors’ side too. On average, a single copyright license agreement can consume about 6 hours of a study project manager’s time throughout the entire license life cycle. That’s a lot of time.

Patient-reported and clinician-reported outcome measures have been used in all kinds of clinical trials for decades.

What’s the deal?

There are several reasons for this. Two main ones: 

1. The licensors are hard to find, and/or 

2. The licensors don’t understand your business and/or your needs. 

It’s really just that.

The latter is a classic and an enduring value misalignment in the service provider-customer relationship.

The flip side of that is that, collectively, we’re not communicating how our industry works and how and why our needs have changed. Who has time for that, right? They should know! You just need to get your hands on that document yesterday, and move on with your study.

What to do…

The greater majority of rating scales commonly used in clinical trials are owned or managed by publishers. Pharma represents just a relatively tiny market segment in their overall global customer portfolios. Depending on their core market and size, copyright agencies and publishers have little to no incentive to adjust their processes to the needs of pharma unless we insist on it.

Do we need them to adjust?  Absolutely!

Times have changed, our regulatory requirements have changed, and how we use rating scales in clinical trials has changed. These changes impact legacy copyright license terms that permit what we can and cannot do with copyrighted works. Outdated or assigned-to-third-party copyright licensing processes and agreement terms slow down your effort in getting a document that is appropriate for your purpose, and in a timely manner.

When you zoom in closer, though, this eternal challenge has 3 distinct factors that play into how efficient you will be in securing an appropriate copyright permission:

1. Your specific purpose – your clinical trial, and in some cases, also the much less understood integration of rating scales into digital data collection platforms (i.e., eCOA/ePRO applications).

  2. Your level of skill in licensing rating scales for clinical trials – your knowledge of where to look and the resources available to you, how to confirm copyright ownership, and how to ensure that the license terms are not in conflict with your internal organizational and regulatory workflows.

3. The copyright licensor’s readiness for your request – in other words, their licensing process and familiarity with your data flow and regulatory review requirements. This is the one that is firing up your senses and compromising your effort for improved efficiency.

If copyright licensing, or “scale management”, as big pharma calls it, is part of your role, and you’re still trying to figure out how this works, then stick with me here.

It’s a big topic. I’ll keep it as succinct as possible, and break it down into 3 separate parts to make it easier for you to absorb.

Each part is intended to help you understand what factors play into the challenge of securing copyright permissions for rating scales, and what you need to do to get your licensing done faster.

Part 1 — Copyright Licensing: Purpose and Situation

Part 2 — Copyright Licensing: Your Experience and Skill

Part 3 — CopyrightLicensors:  Authors, Publishers and Collectives

Disclaimer: Please note that I, the author of this article series, am not a lawyer. The information in these articles is based solely on my own experience with licensing rating scales, and may not reflect the experience(s) of another party. The information in this article series is intended for informational purposes only, and should not be construed as legal advice or legal opinion on any specific facts or circumstances. Additionally, the information about copyright collective agencies is true at the time of writing of this article series and may change at any time. Readers should seek professional counsel specializing in Intellectual Property Law when acting on the information provided in this article series.

Updated January 15, 2025