There are several key points to consider when conducting attention-deficit/hyperactivity disorder clinical trials.
Select clinically meaningful endpoints.
Spend more time determining endpoints and less time deciding what rating scale will be used. Consult with opinion leaders, regulatory experts, statisticians and a medical director before selecting an endpoint.
Use centralized, experienced sites.
Use sites with experience in ADHD trials, along with solid track records in patient enrollment and data quality. Selecting the right patient population is critical because compliance to the study design is key to the success of the execution.
Online ADHD assessment tools reduce stress and increase data quality.
With online tools, parents can complete assessments on their own time rather than returning forms to the site. In addition, sites are able to ensure consistent scoring and decreased error from manual scoring because the scoring is completed automatically by the system.
Carefully manage short visit windows.
The laboratory classroom portion of studies are typically conducted on Saturday. If a narrow visit window can’t be avoided, stay abreast of this issue to avoid protocol deviations for visits outside the window and drop-outs.
Patient diaries aren’t all they’re cracked up to be.
Diaries allow patients to provide information at any time, but can lead to dirty data. When collecting dosing information, think about how you plan to use it. Reducing the burden on patients and sites helps ensure useful data that can tell the right story in your clinical study report.
Written by Guest Writer Kristen Snipes. Snipes has over 18 years of pharmaceutical industry experience primarily as a program manager or clinical operations lead. Since joining Rho in 2007, she has been involved in leading and coordinating all operational activities for complex trials. She is the Clinical Operations Service Lead for Rho, her responsibilities include keeping the company current on industry trends and practices, as well as supporting training and process development. www.rhoworld.com
This article was reprinted from Volume 23, Issue 07, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>
