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P138 An innovative approach to study design: using electronic medical records to inform the feasibility and design of the novelty study (a novel observational longitudinal study on patients with asthma and/or copd)


The NOVELTY study is supported by AstraZeneca.

M Gerhardsson de Verdier, C Keen, A Gardev, S Rennard, A Sveréus, L Brannman, N Karlson, J Nuevo, F Nyberg and S Young are employees of AstraZeneca.

HK Reddel has participated in advisory boards for AstraZeneca, GlaxoSmithKline and Novartis, a data safety monitoring board for AstraZeneca, GlaxoSmithKline, Merck and Novartis, has provided independent educational presentations for AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Mundipharma and Teva, and has received independent research funding from AstraZeneca and GlaxoSmithKline.

R Beasley has received research funding from Astra Zeneca, Genentech, Cephalon, GlaxoSmithKline, Novartis and Sanofi, and has received payments for lectures and/or participation in advisory boards from AstraZeneca, GlaxoSmithKline and Novartis.

EH Bel received research grants from Roche, AstraZeneca, GlaxoSmithKline, and honoraria for research consulting from AstraZeneca, GlaxoSmithKline, Novartis, and Sanofi/Regeneron.

C Janson has no disclosures to declare.

B Make has received honoraria for participation in NOVELTY planning meeting, and has received grant funding, participated in advisory boards and provided non-branded talk for AstraZeneca. He has received honoraria for participation in medical advisory boards for Aerocrine, Boehringer-Ingelheim, CSL Bering, GlaxoSmithKline, Forest, Novartis, Spiration, Theravance, and Sunovion. He has participated in research studies funded by Boehringer-Ingelheim, GlaxoSmithKline, Pfizer, Forest, Sunovian.

RJ Martin has received consulting fees from AstraZeneca, Teva, Genentech, Boeringer Ingelheim, and PMD. His institution has received grants from NHLBI (AsthmaNet) and MedImmune. He has also received travel/accommodation/meeting expenses from the Respiratory Effectiveness Group.

I Pavord has received speaker’s honoraria for speaking at sponsored meetings from Astra Zeneca, Boehringer Ingelheim, Aerocrine, Almirall, Novartis, and GSK and a payment for organising an educational event from AZ. He has received honoraria for attending advisory panels with Almirall, Genentech, Regeneron, Astra Zeneca, Boehringer Ingelheim, GSK, MSD, Schering-Plough, Novartis, Dey, Napp and Respivert. He has received sponsorship to attend international scientific meetings from Boehringer Ingelheim, GSK, Astra Zeneca and Napp.

D Price has board membership with Aerocrine, Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Meda, Mundipharma, Napp, Novartis, and Teva Pharmaceuticals; consultancy with Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma, Napp, Novartis, Pfizer, and Teva Pharmaceuticals; grants and unrestricted funding for investigator-initiated studies (conducted through Research in Real-Life Ltd and Observational and Pragmatic Research Institute Pte Ltd) from UK National Health Service, British Lung Foundation, Aerocrine, AKL Ltd, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Eli Lilly, GlaxoSmithKline, Meda, Merck, Mundipharma, Napp, Novartis, Orion, Pfizer, Respiratory Effectiveness Group, Takeda, Teva Pharmaceuticals, and Zentiva; payments for lectures/speaking from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Meda, Merck, Mundipharma, Novartis, Pfizer, Skyepharma, Takeda, and Teva Pharmaceuticals; payment for manuscript preparation from Mundipharma and Teva Pharmaceuticals; patents (planned, pending or issued) from AKL Ltd; payment for the development of educational materials from GlaxoSmithKline and Novartis; stock/stock options from AKL Ltd which produces phytopharmaceuticals; owns 80% of Research in Real Life Ltd, 75% of the social enterprise Optimum Patient Care Ltd and 75% of Observational and Pragmatic Research Institute Pte Ltd; received payment for travel/accommodations/meeting expenses from Aerocrine, Boehringer Ingelheim, Mundipharma, Napp, Novartis, and Teva Pharmaceuticals; funding for patient enrolment or completion of research from Almirall, Chiesi, Teva Pharmaceuticals, and Zentiva; and peer reviewer for grant committees of the Medical Research Council (2014), Efficacy and Mechanism Evaluation programme (2012), HTA (2014).

AT Bansal is a paid consultant of AstraZeneca, GlaxoSmithKline, hVivo and Roche.

J Vestbo has received honoraria from AstraZeneca, Boehringer-Ingelheim, Chiesi, GlaxoSmithKline and Novartis for advising and presenting.

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