Overview of comments received on 'ICH reflection paper on proposed ICH guideline work to advance patient focused drug development’

Stakeholder no.

Section No.

Comment and rationale

Proposed change / recommendation

Kaiku is a digital health intervention platform (DHI) created to improve cancer patients´safety during their cancer treatments and follow up after treatments. Kaiku collects electronic patient reported outcomes (ePRO) from cancer patients and provides data direct to patients´ health care professionals (HCPs). With Kaiku, ePROs are monitored in an active manner instead of the traditional passive PRO data collection done in clinical trials. Collected data, patients´ symptoms arising from cancer treatment, helps clinicians and investigators to early detection of serious adverse events and disease progression. Having ePROs a part of cancer care has been shown to increase patients´ time on treatment, decrease the severity of adverse effects (severe adverse events, SAE), emergency room (ER) visits and hospitalization and also increase overall survival (OS) (1-3). Kaiku´s symptom questionnaires are treatment-based questionnaires and have been used in clinical trials, drug development and in routine care in many European countries. Patients are able to fill the questionnaires via electronic applications like smartphone, tablet or computer and report symptoms through the assigned questionnaires to the clinics. Kaiku Health has collaborated with several pharma companies for better understanding of patients’ experience in treatment and drug development in phase II – III trials. Our own experience has been that the collaboration with pharma companies is very productive and benefiting the patients.

Overview of comments received on 'ICH reflection paper on proposed ICH guideline work to advance patient focused drug development’ (EMA/CHMP/ICH/415588/2020) EMA/194133/2021

Page 12/60