Clinical Research and GCP Update

UK MHRA … applicant company will be asked for evidence on the patient involvement. Blog 23Mar2021

• When new applications for selected medicines (new active substances and new indications) are received, the applicant company will be asked for evidence on the patient involvement • Additional information won’t be requested now • MHRA will be documenting in medical assessment reports if there is evidence of patient involvement… • During the pilot, information provided by the applicants will be voluntary and will not alter the outcome of application. • In future, the agency hopes that a successful pilot will lead to patient involvement playing a greater role in the final assessment process, when clinical trials are approved,

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ICH E8(R1) Draft: Considerations in Identifying Critical to Quality Factors

• Engagement of all relevant stakeholders • The prerequisite non-clinical studies, and where applicable, clinical studies, are complete and adequate to support the study being designed. • The study objectives address relevant scientific questions • The clinical study design supports a meaningful comparison of the effects of the drug when compared to the chosen internal or external control groups. • Adequate measures are used to protect subjects’ rights, safety, and welfare • A feasibility assessment is conducted to ensure the study is operationally viable. • The number of subjects included, the duration of the study, and the frequency of study visits are sufficient to support the study objective.

See E8(R1) section 7

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