Response of Trial Subjects to the Packing Form of an Investigational Product

概要

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In some clinical trials, the packing form of an investigational product is modified to improve the compliance or recognize it easily. However, it is not clarified whether such device is helpful to trial subjects, or whether they accept a different size packing form or a different appearance from the usual one. To elucidate which form of packing is desirable for them, we investigated their responses to the different type of the packing forms used in clinical trials of our hospital.(N=38)<BR>Our results indicate that the device indicating the time and the way of taking medicine directly to the packing is well accepted by the subject, and helpful for the self-check of drug administration. Portability and easy handling of the packing are requested, and further improvement is necessary. Since the subjects are quite different based on the study protocols, packing form fitted to the subjects in each study should be considered.<BR>Modification of the device to the packing form of an investigational product is important and effective to increase the quality of clinical trials. It is necessary to examine the packing form from the viewpoints of merits for both the subjects and the sponsor, including the convenience for the subjects.