Pharmaceutical Industry

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Michael J Sorich - One of the best experts on this subject based on the ideXlab platform.

  • data sharing from Pharmaceutical Industry sponsored clinical studies audit of data availability
    BMC Medicine, 2018
    Co-Authors: Ashley M Hopkins, Andrew Rowland, Michael J Sorich
    Abstract:

    Background Clinical trial transparency is important to participants, trialists, publishers, and regulators, and there have been recent major policy changes by the Pharmaceutical Industry regarding clinical study data sharing. However, it is unknown if these changes are enabling independent researchers to access participant-level data from prominent contemporary clinical trials sponsored by the Pharmaceutical Industry 2 years after publication of the primary results.

  • data sharing from Pharmaceutical Industry sponsored clinical studies audit of data availability
    BMC Medicine, 2018
    Co-Authors: Ashley M Hopkins, Andrew Rowland, Michael J Sorich
    Abstract:

    Clinical trial transparency is important to participants, trialists, publishers, and regulators, and there have been recent major policy changes by the Pharmaceutical Industry regarding clinical study data sharing. However, it is unknown if these changes are enabling independent researchers to access participant-level data from prominent contemporary clinical trials sponsored by the Pharmaceutical Industry 2 years after publication of the primary results. PubMed and ClinicalTrials.gov were searched to identify clinical trials of medicines sponsored by the Pharmaceutical Industry and first published between 1 July 2015 and 31 December 2015 in the top 10 general and internal medical journals by impact factor. For each clinical trial, the eligibility of independent researchers to request participant-level data was identified via the sponsor having a data sharing policy/process and a positive response to an enquiry. Fifty-six publications reporting on 61 Industry-sponsored clinical trials were identified, of which 32 (52%) had a public data sharing policy/process and 9 (15%) were confirmed eligible for data sharing. Industry sponsors within the top 25 by global sales were more likely to have a data sharing policy (93% vs 10%), and there was a trend towards increased data sharing eligibility (23% vs 4%). Twenty-six studies were explicitly confirmed as ineligible for data sharing. The two most common data sharing policy conditions that prevented sharing of data for published results were the exclusion of studies that had ongoing follow-up of the published results and the exclusion of studies of medicines that have not yet achieved regulatory approval in the USA and the European Union. Fifteen percent of the sampled clinical trials were available for data sharing 2 years after publication of primary results of the trial. Key issues limiting data sharing include a large proportion of Industry sponsors who do not have a data sharing policy/process, and data sharing policy conditions that exclude access on the basis of ongoing follow-up and regulatory activity.

F M Scherer - One of the best experts on this subject based on the ideXlab platform.

  • mergers and innovation in the Pharmaceutical Industry
    Journal of Health Economics, 2013
    Co-Authors: William S Comanor, F M Scherer
    Abstract:

    Conflicting trends confound the Pharmaceutical Industry. The productivity of Pharmaceutical innovation has declined in recent years. At the same time, the cohort of large companies who are the leading engines of Pharmaceutical R&D has become increasingly concentrated. The concurrent presence of these trends is not sufficient to determine causation. In response to lagging innovation prospects, some companies have sought refuge in mergers and acquisitions to disguise their dwindling prospects or gain R&D synergies. On the other hand, the increased concentration brought on by recent mergers may have contributed to the declining rate of innovation. In this paper, we consider the second of these causal relationships: the likely impact of the recent merger wave among the largest Pharmaceutical companies on the rate of innovation. In other words, have recent mergers, which may have been taken in response to lagging innovation, represented a self-defeating strategy that only made Industry outcomes worse?

  • the Pharmaceutical Industry prices and progress
    The New England Journal of Medicine, 2004
    Co-Authors: F M Scherer
    Abstract:

    In this Health Policy Report, the author examines the economics of the Pharmaceutical Industry. Research-and-development costs, patent laws, and health insurance coverage all influence drug pricing. The author discusses the policy dilemmas resulting from the complex economics of Pharmaceutical research and development and reviews potential strategies to control prices.

  • the Pharmaceutical Industry
    Research Papers in Economics, 2000
    Co-Authors: F M Scherer
    Abstract:

    This Handbook chapter surveys the extensive body of research on the economics of the Pharmaceutical Industry (with peripheral attention paid also to regulated medical devices). Pharmaceuticals is one of the world's most research-intensive industries, generating a continuing steam of new products that save lives and raise the quality of life. The discovery of new drugs has evolved over time from a decidedly empirical process to one based to a considerable degree upon fundamental scientific knowledge. Rich linkages have emerged between profit-seeking manufacturers and basic research performers such as universities and national laboratories. The safety and efficacy of new Pharmaceutical products are stringently regulated in most industrialized nations, adding to clinical testing costs. Because of high expenditures on research, development, and clinical testing and because new products, once proven, might be imitated easily, patent protection is unusually important. The extension of patent protection to third-world nations under Uruguay Round Treaty mandates has precipitated vigorous policy debates. Patents, first-mover advantages, and the lack of good substitutes for significant new drugs often give rise to substantial monopoly power, against which many national governments have counterpoised a diverse panoply of price control mechanisms. When patents expire, however, generic substitutes often introduce vigorous price competition. The extent to which generics capture market share from the branded original drugs depends upon government regulatory policies, the reimbursement strategies of health care insurers, and the organization of health care provider institutions.

David Grande - One of the best experts on this subject based on the ideXlab platform.

Ashley M Hopkins - One of the best experts on this subject based on the ideXlab platform.

  • data sharing from Pharmaceutical Industry sponsored clinical studies audit of data availability
    BMC Medicine, 2018
    Co-Authors: Ashley M Hopkins, Andrew Rowland, Michael J Sorich
    Abstract:

    Background Clinical trial transparency is important to participants, trialists, publishers, and regulators, and there have been recent major policy changes by the Pharmaceutical Industry regarding clinical study data sharing. However, it is unknown if these changes are enabling independent researchers to access participant-level data from prominent contemporary clinical trials sponsored by the Pharmaceutical Industry 2 years after publication of the primary results.

  • data sharing from Pharmaceutical Industry sponsored clinical studies audit of data availability
    BMC Medicine, 2018
    Co-Authors: Ashley M Hopkins, Andrew Rowland, Michael J Sorich
    Abstract:

    Clinical trial transparency is important to participants, trialists, publishers, and regulators, and there have been recent major policy changes by the Pharmaceutical Industry regarding clinical study data sharing. However, it is unknown if these changes are enabling independent researchers to access participant-level data from prominent contemporary clinical trials sponsored by the Pharmaceutical Industry 2 years after publication of the primary results. PubMed and ClinicalTrials.gov were searched to identify clinical trials of medicines sponsored by the Pharmaceutical Industry and first published between 1 July 2015 and 31 December 2015 in the top 10 general and internal medical journals by impact factor. For each clinical trial, the eligibility of independent researchers to request participant-level data was identified via the sponsor having a data sharing policy/process and a positive response to an enquiry. Fifty-six publications reporting on 61 Industry-sponsored clinical trials were identified, of which 32 (52%) had a public data sharing policy/process and 9 (15%) were confirmed eligible for data sharing. Industry sponsors within the top 25 by global sales were more likely to have a data sharing policy (93% vs 10%), and there was a trend towards increased data sharing eligibility (23% vs 4%). Twenty-six studies were explicitly confirmed as ineligible for data sharing. The two most common data sharing policy conditions that prevented sharing of data for published results were the exclusion of studies that had ongoing follow-up of the published results and the exclusion of studies of medicines that have not yet achieved regulatory approval in the USA and the European Union. Fifteen percent of the sampled clinical trials were available for data sharing 2 years after publication of primary results of the trial. Key issues limiting data sharing include a large proportion of Industry sponsors who do not have a data sharing policy/process, and data sharing policy conditions that exclude access on the basis of ongoing follow-up and regulatory activity.

Scott E Hadland - One of the best experts on this subject based on the ideXlab platform.