Should Global Clinical Studies be Conducted Under the United States Investigational New Drug Application?

Abstract

A global Investigational New Drug (IND) Clinical Studies Task Force was established in 1999 by the Johnson & Johnson Pharmaceuticals Group with representation from The R. W. Johnson Pharmaceutical Reseach Institute, The Janssen Research Foundation, and several Janssen-Cilag operating companies. This task force was charged with evaluating the need for the conduct of global clinical trials in accordance with the United States IND as prescribed by Part 312 in Chapter 21 of the United States Code of Federal Regulations in order for such trials to be accepted by the Food and Drug Administration (FDA) in support of a regulatory submission. The task force recommends that global product teams consider the possibility of conducting clinical studies under the United States IND, wherever possible, in establishing product development strategies. While there are distinct advantages to conducting clinical trials under the IND, the task force points out that the responsibilities incurred can be a challenge globally in terms of administrative oversight, adequate internal resources, and continuous training on United States IND requirements for internal and clinical trial center personnel. Therefore, the task force advises that these factors be evaluated by the global product teams and recognizes that it may not be appropriate for all clinical trials to be conducted under the IND. Whether or not the global product team decides to conduct pivotal trials under the IND, it is essential that all clinical trials be conducted in accordance with Good Clinical Practice (GCP) standards as outlined by the International Conference on Harmonization (ICH) to ensure their acceptance by regulatory authorities worldwide. The IND Clinical Studies Task Force urges global product teams to include up-front dialogue with the FDA on development strategies. This is especially important when clinical study centers outside the United States are not filed to the IND. Dialogue with FDA is critical to the selection of clinical study centers on a geographic basis and the definition of systems used for the monitoring of all study sites as well as for the collection, analysis, and communication of safety information on a global basis throughout the conduct of global clinical trials.