Multinational Drug Development and Clinical Research: A Bird's Eye View of Principles and Practice

Philipp, E.; Weihrauch, T. R.

doi:10.1177/009286159302700428

Cited by 5 publications

(2 citation statements)

References 20 publications

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“…Until it can be ensured that good science is practiced at all levels, that only those studies that are required to prove safety and efficacy are designed and efficiently conducted, that the resulting data are valid using validated systems, and that the submissions are in an acceptable electronic format, there will not be major improvements in elapsed time and control of the costs of new drug development, as well as significant decreases in review time. As Philippe and Weinrauch (22) have pointed out, there can be several reasons for prolonged development time:…”

Section: Prolonged Development Timementioning

confidence: 99%

The Drive toward Regulatory Harmonization: What is Harmonization and How Will it Impact the Global Development of New Drugs?

Worden¹

1995

Drug Information Journal

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A great deal of discussion is heard about regulatory harmonization and efforts to shorten the drug submission regulatory review process. This article provides a historical perspective of the International Conference on Harmonization (ICH), its organizational structure, objectives, the five-step process, status of ICH guidelines, and recent progress. It also examines other "harmanization '' initiatives such as the Declaration of Helsinki, World Health Organization (WHO), Council for International Organizations of Medical Sciences I (CIOMS I), CIOMS II, International Standards Organization (ISO) 9000, and European Union (EU) directives and regulations related to medicinal products. As a consequence of the growing body of regulations that have expanded the drug development process, it is appropriate to reevaluate drug development information needs and consider necessary changes in the management of the process to improve the quality of submissions and to reduce the global time to market.

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Section: Prolonged Development Timementioning

confidence: 99%

The Drive toward Regulatory Harmonization: What is Harmonization and How Will it Impact the Global Development of New Drugs?

Worden¹

1995

Drug Information Journal

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“…Ubersichten zu einigen grundlegenden Aspekten sind in den letzten Jahren erschienen [5][6][7]. Ubersichten zu einigen grundlegenden Aspekten sind in den letzten Jahren erschienen [5][6][7].…”

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Multinationale klinische Therapiestudien (MTS)

Demol

Weihrauch

1997

Med. Klin.

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The development of new drugs requires increasingly the performance of large multinational clinical trials (MCT) with a common protocol. They must be planned when the demonstration of a hypothesis, which requires specific conditions (for example availability of patients with rare diseases, a particular infrastructure or expert knowledge in trial centers) has to be proven in an acceptable time. Our own experience has shown that such multinational trials are more time-consuming in their preparation and their analysis than multicenter trials which are run in one country. MCTs are associated with complex problems due to many differences in medical culture, treatment strategies, administrative guidelines, etc., between countries. When possible MCTs should be realized in countries and centers with relatively similar medical practices. A global coordination is necessary to control the progress of the trial in the different countries. The major requirements for the successful realisation of an MCT, from the writing of the first draft of the protocol until the publication of the results, are a well-coordinated multidisciplinary team and an effective project management.

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Design and Analysis of Multinational Clinical Trials

Chow

1998

Drug Information Journal

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Multinational Drug Development and Clinical Research: A Bird's Eye View of Principles and Practice

Cited by 5 publications

References 20 publications

The Drive toward Regulatory Harmonization: What is Harmonization and How Will it Impact the Global Development of New Drugs?

The Drive toward Regulatory Harmonization: What is Harmonization and How Will it Impact the Global Development of New Drugs?

Multinationale klinische Therapiestudien (MTS)

Design and Analysis of Multinational Clinical Trials

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