PubMed · 14157250
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A SMITH. 1964. CURRENT PHARMACEUTICAL DEVELOPMENT--ITS PROBLEMS AND FUTURE.. https://pubmed.ncbi.nlm.nih.gov/14157250/
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The ability to manage risk depends critically on an understanding of the degree to which a known risk is balanced by the probability of a clinical benefit. Despite the massive emphasis on risk and risk management in the past few years and the long-term focus on defining benefit in the regulatory system, considerable uncertainty remains about the methods of defining benefit and how to operationalize this knowledge. In this 'think tank,' part of a larger series on risk management, issues were divided into those that can be identified before a study is initiated, those that commonly arise after a study is completed, biomarkers and surrogates, use of benefit findings in defining quality and performance indicators, implementation of findings into health systems and formularies, and methods of comparative trials. Key categories for the establishment of a research agenda to fill in gaps in our understanding of assessing benefit were developed by the group.
Between just 1995 and 2003, the number of new chemical entities fell from 45 to 25, while the costs increased by two and a half times in the same period. Firms in the USA accounted for more than half of biotech drugs from 1982 to 2003. European firms are losing competitiveness. In this hostile environment for investment in pharmaceutical R&D, providing quick access to market for real innovations is the main challenge for regulatory agencies. More initiatives, more entrepreneurial spirit and easier work regulation are needed to facilitate the growth of firms in this field, especially in emerging economies like the Spanish. A new open source model proposes the use of pre-competitive public platforms formed by young and qualified human capital carrying out research in areas not sufficiently attractive for private initiatives, followed by the introduction of pharmaceutical companies to carry out the clinical research. The last step would be fast and effective approval by assessment agencies. Governments should, therefore, facilitate the regulation of socially effective innovations, bringing in manufacturers to take part in the post-clinical trial period after entering the market. The gathering of incentives between regulatory agencies and pharmaceutical industry must be approached through innovation and authorization stimulating systems.