Industry Efforts on Simultaneous Global Development
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Industry Efforts on Simultaneous Global Development
Jean-Louis Saillot, MD Vice President. Global Project Management , Schering-Plough Research Institute
Mark Paxton, JD Associate Vice President, International Regulatory Affairs. PhRMA
Key Words Simultaneous; Global development; Multiregional; Clinical: Studies; Trials; China; Korea; Japan; Chinese Taipei Correspondence Address Mark Paxton. ID, PhRMA, 950 F Street, Washington. DC, 20004 (email: [email protected]).
Given the cuwent size and complexity of pharmaceutical development pmgrums, continued improvements to streamlinethe development of new and innovative medicines are critical. Despite significant operational challenges, the conduct of global studies using a singleprotocd across multiple regions is considered by the innovativepharmaceuticalindustry as an efficient approach to clinical development. This philosophy is in line with the drivers behind the creation of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); specifically, the development of harmonized guideline documents, includingZCH E5 (Ethnic Factors in the Acceptability of Foreign Clinical Data). However, despite very significant progress made with the implementationand acceptance of ICH guidelines, bam'ers to the conduct and acceptability of global development approachesstill remain. f i e need for simultaneous global development has been recognized as significant, not
INTRODUCTION It is doubtful that there are many people who fail to understand that patient access to meaningful, new, evidence-based medicinal therapies is critical to maintaining healthy populations. Unfortunately however, the size and complexity of development programs for such therapies is ever increasing and resources that could best be used for increasing research and development (R&D) productivity are often used to meet different regulatory requirements that may add little to the evaluation of the risk-benefit of new therapies. Pharmaceutical development in most of the world is immensely costly. It is the price to be paid to establish a sufficient body of clinical and scientific evidence to ensure that newly introduced innovative medicines are safe and effecDxug Information Journal. Vd.43, pp. 339-342 2009 0092-8615/2009
only by the pharmaceuticalindustry, but also by a number of governmental agencies. Eforts exist now to evaluate the challenges associated with the conduct of global studies. To make recommendations to facilitate simultaneousglobal development, a multifunctionalgroup of experts within the Scientific and Regulatory technical groups of PhRh4A member companies was convened as the SimultaneousGlobal Development Committee. This article only describes the initial observations of the committee and is expected to be fdlowed by future articles on a series of concrete recommendations to address issues inhibiting simultaneousglobal development. Initial activities of the committee have focused on developing a more rigorous identificatio
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