Successful Design and Conduct of a Treatment IND Program
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Drug Infomarion Journal, Vol. 34, pp. 165-172, 2000 Printed in the USA. All rights reserved.
SUCCESSFUL DESIGN AND CONDUCT OF A TREATMENT IND PROGRAM* CELESTE DIJOHNSON, MA Senior Clinical Research Manager, Cephalon, Inc., West Chester, Pennsylvania
In order to maximize the success of a Treatment Investigational New Drug (IND)program, a fairly elaborate infrastructure that includes a multitude of service groups may be necessary. The program support may consist of a combination of internal sponsor groups as well as contract research organizations. The intent of this manuscript is to highlight and describe in detail the variety of services and responsibilities that may be required to conduct a Treatment IND program, while focusing on design, logistics, structure, worhflow, and potential strategies for managing challenging issues relating to the program. Key Words: Treatment IND; Treatment use protocol; Early access; Expanded access; Compassionate use
INTRODUCTION AS DOCUMENTED IN the March 19, 1987 Federal Register notice, known familiarly as the IND Rewrite, the United States Food and Drug Administration (FDA) introduced the Treatment Investigational New Drug (IND) in an effort to facilitate the availability of promising new drugs for patients with serious or immediately life-threatening diseases for which no comparable or satisfactory alternative drug is available. The intent of the Treatment IND is to allow desperately ill patients access to an investigational drug prior to marketing approval as early as possible in the drug development process. During the conduct of a Treatment IND study, additional data regarding the safety and effectiveness of a drug are obtained. Since the inception of the Treatment IND Reprint address: Celeste Dilohnson, MA. Sanofi-SynthClab0 Research, 9 Great Valley Parkway, Malvern, PA 19355. are solely those of the author *neviews and do not represent an official position of Cephalon, Inc.
by the FDA in 1987, a variety of clinical indications have been represented in those Treatment IND programs currently underway, including treatments for AIDS and various types of cancer. The purpose of this manuscript is to describe in detail the design and conduct of one such ongoing Treatment IND program, with a focus on basic issues to consider for implementation and program success. Cephalon, Inc., a biopharmaceutical company, sponsored the Treatment IND program described herein.
TREATMENT IND PROGRAM HISTORY In October of 1995, Cephalon, Inc. filed a Treatment IND application with the FDA to provide patients with access to an investigational drug for the treatment of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disorder that leads to respiratory failure and eventual death. ~~l~ in gust of 1996, following an FDA advisory panel recommendation for approval and subsequent approval of the Treatment IND by
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Celeste DiJohnson
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the FDA, patient registration for the Treatment IND program commen
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