Innovations and Use of Technology in Dermatology Clinical Trials and DCT’s

eCOA: Digitization of PRO and ClinRO in Dermatology

Electronic patient-reported outcomes (ePRO) and electronic clinician-reported outcomes (eClinRO) are an essential component to clinical trials and decentralized clinical trials (DCTs) in dermatology. There are a number of skin conditions such as psoriasis and atopic dermatitis that are chronic conditions in which symptoms progress slowly over time. Utilization of ePRO and submission of skin images by patients to central raters enables more effective, accurate and standardized ratings for these conditions. In addition, by digitizing the ClinRO, the burden is removed from the site rater as branching, scoring and edit checks ensure complete and accurate scoring from the sites.

Digital Patient Training

Placebo response rates are high in dermatology clinical trials as many of the symptoms, such as itchiness and dryness can be prone to placebo effects. Use of interactive digital patient training solutions that relay the roles and responsibilities of the patient in the study, set expectations, train on accuracy in reporting on ePROs and educate on how to mitigate placebo effect have been proven to improve data quality and completeness.

Digital Rater Training and Qualification

Rater training is an effective strategy for improving data quality in clinical trials. Innovations in technology have enabled qualifying of raters using their own smartphones, pre-screening raters to determine who is a naïve versus an experienced rater and then tailoring the appropriate amount of training for a rater. Using these digital strategies, raters are not under or over-trained. Training site raters on key assessments such as the PASI/BSA, sPGA, NAPSI, EASI/BSA, SCORAD and IGA is crucial as there are key components that introduce significant rater variability in these assessments. For example, for the PASI, raters are trained on how to properly assess BSA, applying a consistent approach to palm measurement, how to score more complex conditions such as erythema on different skin tones and central clearing and provided actual patient videos and images.

Images and Central Expert Raters

In dermatology, the paradigm is shifting from studies with heavy site burdens and in clinic assessments to having patients take and submit images of skin lesions and rashes in diseases such as psoriasis, atopic dermatitis and injection site reactions. The technology enables images to be taken with the proper resolution, lighting and positioning and removes any potential personal identifying information from the image. These images can then be rated in a standardized capacity using central expert dermatology raters, resulting in optimized data quality and a signal to noise ratio.