Common Challenges in Endpoint Assessment Training
Endpoint assessment management is an often-cited pain point for both Sponsors and Immuno-dermatology Investigators. This can happen because Dermatology Rater Scale designs are inconsistent and are often recreated on a study-by-study basis – even when there is no scientific reason to do so.
The stakes are high for improperly prepared raters. Deviations and variance can contribute to bad data and even failed trials. Creating a Rater Scale Training strategy not only helps investigators understand the instrument, it eliminates start-up delays and frustration.
Here are three key items to consider during rater training selection.
Consistency is key
A standardized certification method ensures that all rater’s qualifications are assessed in the same manner. Using an online training platform provides the opportunity to automate the measurement of inter/intra rater reliability and provide remediation or refresher training when indicated. In dermatology clinical trials, the data collected is only as good as the investigator’s use of the scale being used to evaluate the patient. Having high quality images to represent specific severities of disease states, reduces rater variability that can ultimately compromise the study data.
Content is king
Look for a training program that supports a range of scales and indications. Some indications and scales present specific assessment challenges that are best supported by a specialized process and/or technology. For example, Alopecia and Vitiligo each have specific, but very different challenges. These projects require the training content to be precise and the platform purposely built to position the trial for success.
During a time when virtual training is becoming the norm, the importance for superior rater training that accurately reflects the clinical representations of patients is crucial. Delivery of such training on a platform that enables the delivery of the content in a consistent manner, decreases the variability of rater training and qualification.
Mutual recognition of rater training
Choosing a training program that delivers consistent rater training content and also maintains prior rater training certifications, not only saves investigators valuable time, but also allows sponsors and CROs to quickly identified qualified raters. Cross-sponsor mutual recognition of training is also ideal, in that a training certification earned for one scale on one sponsor’s trial can be recognized by another sponsor’s trial if desired.
In summary, look for solutions that bring technology and content together to provide assessment training that creates both efficiency for investigators and clarity for sponsors in support of better outcomes for patients. Also keep in mind that, solutions that eliminate redundancy in certification through endpoint management will enable Sponsors to reduce the burden on Investigators while improving compliance, audit readiness and inter- and intra-rater reliability resulting in better data and a true view into study results.