What matters most? Different stakeholder perspectives on estimands for an invented case study in COPD

Author:

Keene Oliver N.1ORCID,Ruberg Stephen2,Schacht Alexander3,Akacha Mouna4,Lawrance Rachael5,Berglind Anna6,Wright David7

Affiliation:

1. GlaxoSmithKline Stockley Park UK

2. Analytix ThinkingLLC Indianapolis Indiana USA

3. Lilly Deutschland Bad Homburg Germany

4. Novartis Pharma AG Basel Switzerland

5. Adelphi Values Bollington UK

6. AstraZeneca Gothenburg Sweden

7. AstraZeneca Cambridge UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference29 articles.

1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials Step 2b. London: European Medicines Evaluation Agency August2017.http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/08/WC500233916.pdf(accessed August 9 2019)

2. Committee for Human Medicinal Products. Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus.https://www.ema.europa.eu/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-prevention-diabetes-mellitus_en.pdf(accessed August 9 2019)

3. Committee for Human Medicinal Products. Guideline on the clinical investigation of medicines for the treatment of Alzheimer's disease.https://www.ema.europa.eu/documents/scientific‐guideline/guideline‐clinical‐investigation‐medicines‐treatment‐alzheimers‐disease‐revision‐2_en.pdf(accessed August 9 2019)

4. Prioritised research agenda for prevention and control of chronic respiratory diseases

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