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

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Randomized Controlled Trial. Journal of Clinical Oncology. 2016;34(6):557-565. 4. Schmalz O, Jacob C, Ammann J, Liss B, Iivanainen S, Kammermann M, Koivunen J, Klein A, Popescu RA. Digital Monitoring and Management of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Treated With Cancer Immunotherapy and Its Impact on Quality of Clinical Care: Interview and Survey Study Among Health Care Professionals and Patients. J Med Internet Res. 2020 Dec 21;22(12):e18655. Doi: 10.2196/18655. 5. Iivanainen S, Ekström J, Virtanen H, Lang L, Kataja V: Predicting objective response rate (ORR) in immune checkpoint inhibitor (ICI) therapies with machine learning (ML) by combining clinical and patient-reported data. Ann Oncol (2020) 31 (suppl_7): S1428-S1440. 10.1016/annonc/annonc391 6. Popescu RA, Ekström J, Leemann H, Virtanen H, Kataja V: Predicting patient-reported symptoms for patients undergoing immune checkpoint inhibitor (ICI) therapies using different measurement system than in prediction model training. Abstract accepted and presented in the Swiss Oncology & Hematology Congress as ePoster, 18- 21 Nov 2020. SOHC (2020) 7. Iivanainen S, Alanko T, Vihinen P, Konkola T, Ekstrom J, Virtanen H, Koivunen J: Follow-up of Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy by Electronic Patient Reported Outcomes-tool (KISS): a pilot feasibility study. JFR (2020) 4: (10):e17898. Doi: 10.2196/17898

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

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