Clinical Research and GCP Update

ICH E8 R2 Draft and influence on ICH E6(R3): Expect to require Patient Input into Trial Design

Consulting with patients and/or patient organisations in the design, planning and conduct of clinical trials to help ensure that all perspectives are captured. Patients’ views could be requested on all phases of drug development.

See Draft E8(R1) 2.3

69

E8 (R1) Draft: Patient Input into Trial Design

• Involving patients at the early stage of trial design is likely to increase trust in the study, facilitate recruitment, and promote adherence, which should continue throughout the duration of the study. • Patient input also helps to − provide their perspective of living with a condition, which contributes to the determination of endpoints that are meaningful to patients, − select the right population

− consider the duration of the trial − select use of the right comparators. • This ultimately supports the development of medicines that are better tailored to patients’ needs.

See E8(R1) 2.3

70

© Brookwood Global (Canary Ltd) 2021

35