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    Did relaxing clinical trial regulation enhance the stock of scientific knowledge in India? Not necessarily


    Rake, Bastian and Haeussler, Carolin (2019) Did relaxing clinical trial regulation enhance the stock of scientific knowledge in India? Not necessarily. PLoS ONE, 14 (1). ISSN 1932-6203

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    Abstract

    The increasing amount of clinical research conducted outside the “traditional” countries raises questions about the benefits of hosting offshored clinical research. The extent to which trials contribute to the scientific knowledge base and, in particular, whether there are differences between different types of trials remain open questions. By examining a change in clinical trial regulations in India, a country often viewed as a first-choice offshoring loca- tion, we study how the relaxation of clinical trial regulations affects the number and the type of clinical trials as well as the domestic scientific knowledge base. Based on trial data from ClinicalTrials.gov and data on associated publication activities, our empirical analysis sug- gests that, despite an initial increase in the number of clinical trials, relaxing clinical trial reg- ulations has a limited impact on the domestic scientific knowledge base. More specifically , the number of Indian researchers involved in the production of trial-related scientific knowl- edge remains modest. Furthermore, the potential to learn from the additional trials appears to be limited: the influx of phase 3 trials—mainly sponsored by Western-pharm aceutical firms—is accompanied by a lower likelihood that the trial results will be used in Indian researchers’ subsequent research activities when compared to phase 3 trials with preceding phase 2 trials, as was required before the regulatory change. Overall, our results contradict expectations that relaxing the regulatory requirements for conducting late-stage clinical tri- als is an appropriate means of supporting the development of the domestic scientific knowl- edge base.

    Item Type: Article
    Keywords: relaxing clinical trial; regulation enhance; scientific knowledge; India;
    Academic Unit: Faculty of Social Sciences > School of Business
    Item ID: 10415
    Identification Number: https://doi.org/10.1371/journal.pone.0210163
    Depositing User: Bastian Rake
    Date Deposited: 09 Jan 2019 13:03
    Journal or Publication Title: PLoS ONE
    Publisher: Public Library of Science
    Refereed: Yes
    URI:

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