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. 2016:16:92-102.
doi: 10.1007/s10742-016-0144-x. Epub 2016 Mar 5.

Big Data: transforming drug development and health policy decision making

Affiliations

Big Data: transforming drug development and health policy decision making

Demissie Alemayehu et al. Health Serv Outcomes Res Methodol. 2016.

Abstract

The explosion of data sources, accompanied by the evolution of technology and analytical techniques, has created considerable challenges and opportunities for drug development and healthcare resource utilization. We present a systematic overview these phenomena, and suggest measures to be taken for effective integration of the new developments in the traditional medical research paradigm and health policy decision making. Special attention is paid to pertinent issues in emerging areas, including rare disease drug development, personalized medicine, Comparative Effectiveness Research, and privacy and confidentiality concerns.

Keywords: Drug development; Keywords Big Data; Personalized medicine; Predictive analytics; Real world data.

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References

    1. Akhmetov I, Ramaswamy R, Akhmetov I, Thimmaraju PK. Market access advancements and challenges in “Drug-companion diagnostic test” co-development in Europe. Liggett SB, ed. J. Personalized Med. 2015;5(2):213–228. doi: 10.3390/jpm5020213. - DOI - PMC - PubMed
    1. Assuncao, M.D., Calheiros, R.N., Bianchi, S., Netto, M.A.S., Buyya, R. Big Data computing and clouds: challenges, solutions, and future directions. technical report CLOUDS-TR-2013-1, Cloud Computing and Distributed Systems Laboratory, The University of Melbourne. http://arxiv.org/abs/1312.4722. 17 Dec 2013
    1. Augustine EF, Adams HR, Mink JW. Clinical trials in rare disease: challenges and opportunities. J. Child Neurol. 2013;28(9):1142–1150. doi: 10.1177/0883073813495959. - DOI - PMC - PubMed
    1. Barton S. Which clinical studies provide the best evidence? : the best RCT still trumps the best observational study. BMJ. 2000;321(7256):255–256. doi: 10.1136/bmj.321.7256.255. - DOI - PMC - PubMed
    1. Berger M, Mamdani M, Atkins D, Johnson M. Good research practices for comparative effectiveness research: defining, reporting and interpreting nonrandomized studies of treatment effects using secondary data sources. The ISPOR good research practices for retrospective database analysis task force report—Part I. Value Health. 2009;12(8):1044–1052. doi: 10.1111/j.1524-4733.2009.00600.x. - DOI - PubMed

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