The World Medicines Situation 2011 - Research and Development
(2011; 21 pages)

Abstract
  1. Pharmaceutical research and development (R&D) has been critical to the reduction and control of disease but it faces unprecedented challenges. Many have questioned the sustainability of pharmaceutical R&D in the face of burgeoning clinical trial costs and a consistently high failure rate across all development phases.
  2. The mismatch between investments and the likely return from neglected diseases research is a key reason why commercial R&D has been unable to plug all pharmaceutical gaps or to invest in proportion to disease burden.
  3. The industry makes a growing contribution to neglected disease research, even if this remains a relatively small proportion of total research activity. Academic institutions appear to largely follow the same pattern as industry.
  4. Many initiatives have been launched to streamline the research, development and regulatory processes. These will help reduce the costs of innovation. Countries need, however, to strike the appropriate balance between developing new innovative capacity and making more of existing tools, including measures to improve public health through improved diagnosis and prevention. The choice will be different from country to country and depend on economic and technological circumstances.
  5. The need for cost efficiencies has driven a substantial number of clinical trials away from Europe and the USA and into other locations. This movement adds to an increasingly complex regulatory future where a variety of initiatives are emerging that will bring products to market faster, but in a way that requires greater regulatory oversight post-launch. Resources will be needed in all countries to adequately fund such scrutiny.
 
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