Licensing clinical outcomes assessments, or any type of rating scale, can be very simple. However, the advancement of technology used in clinical trials has been complicating the licensing process and extended its progress timelines.
Licensors who are protective of their intellectual property have had a challenging time providing flexibility in their license agreements to allow electronic conversion and/or integration of scales into digital platforms.
There are two key reasons for this:
- Not understanding how their rating scales will be protected from copyright infringement generates fear and stimulates delays due to consultations with legal counsel.
- The integrity of the rating scale is at greater risk, because some measures have complex scoring algorithms. In some cases, the scoring algorithm is considered to be a trade secret and the copyright owner will be reluctant to disclose it, and has to decide whether to allow you to develop your own or to decline your request.
You don’t need to be an attorney or a law clerk to secure copyright licenses. As technology becomes more intertwined with administration of rating scales, it helps to have legal counsel available and to consult with him/her on what you need to have included in your license agreements the before you begin contacting licensors.
Study project managers, commonly at the entry level, manage copyright licensing of rating scales in the pharma industry. It’s an administrative task that is perceived to be a no brainer. At this level, turnover in study project management staff within CROs and service providers is quite high. Whether copyright licensing of rating scales is carried out by your company, or delegated to a service provider, it is a skill that is routinely learned “on the go”, under very taxing conditions, and commonly without much prior experience and training in copyright.
This happens in the midst of the fast-paced craziness of the most important and most labor-intensive part of the trial – the study start-up phase.
If you’re new to copyright licensing of rating scales, then at least basic training in copyright law and licensing will make a big difference in how efficiently you can master this. This work is not a no brainer. It’s investigative in nature, time-consuming, and the amount of diligence that you put into it is directly linked to level of risk of copyright infringement.
With training, shared guidance and experience, you’ll know how to save yourself a lot of time, what to look for, what you can do to set up for changes, and simultaneously help your licensor serve you better.
Understanding how licensors approach copyright management also fires up your expertise further. You can quickly screen their licenses for conflicts before you pass them on in a rushed email-forward to your counsel for review and sign-off. You know what happens if you don’t screen it and don’t have the ambiguous parts of the license agreement clarified…you get it back with a big chunk of its content lit up in redlined mania. Too many redlined changes can and will delay licensors’ responses…often for weeks.
You can reduce the turnaround time through active interaction with the licensor while they prepare your agreement.
Now, let’s talk about the licensors. This is probably where it will really unfold for you.
Part 3 of this series is dedicated to three types of licensors that you most commonly encounter when licensing rating scales for clinical trials.
Disclaimer: Please note that I, the author of this article, am not a Lawyer. The information in this article is based solely on my own experience in licensing rating scales and may not reflect the experience(s) of another party. The information in this article 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 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.
Updated January 18, 2025
