1. Selection of a clinically meaningful endpoint is critical
At the beginning of a study a lot of time is spent deciding what rating scale will be used, and yet not nearly enough time is spent determining what the precise endpoint will be. Particularly in a study that will be used as part of a marketing application, defining a clinically meaningful primary end point can mean the difference between success and failure. Picking the best end point requires consulting with key opinion leaders, regulatory experts, statisticians, and a medical director experienced in clinical trials. Depending on the phase of development, a special protocol assessment with FDA may be advisable.
2. Use of online ADHD assessment tools can reduce stress on parents and sites while increasing data quality
Using an online assessment tool, parents are able to complete assessments on their own time and don’t have to worry about getting paper assessment forms returned to the site. Making things easier for parents prevents drop-outs, which can cause timeline delays and data issues. Sites’ efforts are reduced because they don’t have to follow up with parents to get the forms, scoring is completed automatically by the system reducing variability in data and they don’t have to transcribe the data from the forms into an electronic data capture (EDC) system. This removes the possibility of data entry errors leading to higher quality data.