Multinational drug companies: Issues in drug discovery and development

In recent years, multinational multicenter trials have become increasingly popular for evaluation of the generalizability of clinical results across different countries. With the implementation of ...

Design and Analysis of Multinational Clinical Trials

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.

[Multi-national clinical therapy studies. Design, management and costs].

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 “harmonization” initiatives such as the Declaration of Helsinki, World Health Organization (WHO), Council for International Organizations of Medical Sciences I (CIOMS I), CIOMSII, 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.

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

Im Rahmen der Entwicklung von Arzneimitteln werden zunehmend multinationale klinische Therapiestudien (MTS) mit einem gemeinsamen Protokoll durchgefuhrt. Sie werden vor allem dann geplant, wenn eine Fragestellung, die spezifische Bedingungen erfordert (wie etwa die Verfugbarkeit von Patienten mit einer seltenen Erkrankung, eine ganz bestimmte Infrastruktur oder Sachkenntnis in Untersuchungszentren) in einer akzeptablen Zeitspanne untersucht werden soll. Eigene Erfahrungen zeigen, das Studienvorbereitung sowie Auswertung und Dokumentation bei multinationalen Studien wesentlich mehr Zeit erfordern als bei multizentrischen Studien innerhalb eines Landes. MTS werfen eine ganze Reihe von Problemen auf, die auf Unterschiede in der medizinischen Praxis und Kultur, behordlichen Vorschriften und der Studienorganisation zuruckzufuhren sind. MTS sollten auf Lander und dort auf Zentren mit ahnlichen medizinischen Verfahren beschrankt werden. Die entscheidende Voraussetzung fur die erfolgreiche Durchfuhrung einer Studie ist — vom ersten Entwurf eines Protokolls bis zur Veroffentlichung der Ergebnisse — eine gut koordinierte Teamarbeit mit einem effektiven Projektmanagement.

Multinationale klinische Therapiestudien (MTS)

The development of a new molecular entity (NME) into a drug can only be successful if the drug meets today's standards in terms of quality, efficacy, safety, and convenience. The better a new drug meets hitherto unmet therapeutic needs, the more successful it will be. Urgent needs for new drugs exist in the areas of chronic diseases. Safety requirements for drugs to be used chronically are paramount. Assessments of the therapeutic benefit as opposed to the risks of a new drug are important criteria for approval. As a consequence of these strict requirements which have precipitated in rules and regulations for biomedical testing and marketing approval in most countries of the world, the drug development process has expanded and in many instances leaves little of the effective patent life to recover the considerable investment needed for an innovation. The ethical and scientific principles of drug development and biomedical research are summarized in a highly condensed manner in the Declaration of Helsinki....

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

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