Including more people with ALS in trials with the TRICALS Risk Score
September 3, 2026
The TRICALS Risk Score is an innovative tool designed to include more people with ALS in clinical trials. By making an individual risk assessment, eligibility for clinical trials can be increased significantly, and 3 out of 4 patients can now participate. This is a considerable improvement, as previously only 5% to 40% of patients were eligible. Recently, TRICALS launched a specialized training program on the use of the TRICALS Risk Score in the TRICALS Academy platform to help trial professionals better understand and utilize the tool.
The TRICALS Risk Score combines seven key patient characteristics, by themselves often used as inclusion criteria, such as symptom duration, diagnostic classification and respiratory capacity, into one single variable.
Ruben van Eijk, associate professor and the researcher behind the score, explains the motivation behind the development of the TRICALS Risk Score: “What we saw was that a lot of people with ALS, despite their enthusiasm and determination to participate, often did not fit standard inclusion criteria. As a result, we not only had to disappoint many patients, but it also turned out to be unnecessary to exclude that many patients to ensure the quality of the trials and their results. With the TRICALS Risk Score we are able to increase the eligibility of ALS clinical trials, while maintaining the same study quality compared to conventional criteria.”
Harmonizing and improving usability through training
Since its implementation in 2020, the TRICALS Risk Score has been used in over 15 clinical trials. The Risk Score cannot only help identify the right study population, but also balance randomized treatment groups and increase the precision of the statistical analysis. The TRICALS Risk Score has thereby been proven to be a vital, helpful and established asset in ALS clinical trials. To ensure the tool is used consistently and in a harmonized and effective way, a TRICALS Risk Score training was recently developed by the TRICALS Academy.
The training provides guidance on how to collect, assess, and define the patient characteristics behind the Risk Score, along with practical examples of how to use the tool/calculator. The training highlights frequently made mistakes and ways to overcome them. This increases usability, between-study comparability, and further enhances the power and reliability of the TRICALS Risk Score.
Ruben: ‘’We are proud to announce the training is now live. When you are considering or using the TRICALS Risk Score in your clinical trial, it is highly recommended to train your site staff on how to adequately use this via the TRICALS Academy.’’
If you are interested in the TRICALS Risk Score or the training, please contact TRICALS to investigate the options.
