The Case For Cognitive Assessments In Phase I Clinical Trials

By Helen Brooker and Pascal Goetghebeur

Patient-focused drug development is increasingly important to regulators, emphasizing patient-reported outcomes in new drug applications. Phase I clinical trials, the initial step toward regulatory approval, primarily assess safety, tolerability, and dosage responses in healthy volunteers. However, cognitive changes due to disease or treatment are often overlooked despite their significant impact on patients’ quality of life.

Early detection of cognitive adverse effects is crucial for avoiding later issues. Despite this, many programs lack sensitive cognitive function assessments. Awareness of their importance is growing, particularly in early-phase trials. Computerized cognitive testing, integrated into Phase I studies alongside other pharmacodynamic measures, offers comprehensive insights into a drug’s cognitive effects, informing safety, tolerability, and efficacy decisions. These assessments help identify cognitive impairments, guide resource allocation, and confirm the absence of unwanted side effects.

See how tools like Signant Health’s CDR System® provide sensitive, reliable, and repeatable cognitive assessments, supporting safer and more effective drug development, by reading the full article below.