Response to Byrne Denis Byrne (1998)  has raised a number of important issues in his letter regarding the potential benefits of a uniform clinical trials protocol for use in manufacturer-sponsored research to substantiate user-benefit claims in applications to the Food and Drug Administration (Walden, 1997). I appreciate his interest in this matter and ... Perspective
Perspective  |   March 01, 1998
Response to Byrne
 
Author Affiliations & Notes
  • Brian Walden, PhD
    Director of Research, Army Audiology and Speech Center, Walter Reed Army Medical Center, Washington, DC 20307-5001
Article Information
Hearing Disorders / Hearing Aids, Cochlear Implants & Assistive Technology / Perspectives
Perspective   |   March 01, 1998
Response to Byrne
American Journal of Audiology, March 1998, Vol. 7, 20-23. doi:10.1044/1059-0889.0701.20
History: Received November 18, 1997 , Accepted December 1, 1997
 
American Journal of Audiology, March 1998, Vol. 7, 20-23. doi:10.1044/1059-0889.0701.20
History: Received November 18, 1997; Accepted December 1, 1997
Denis Byrne (1998)  has raised a number of important issues in his letter regarding the potential benefits of a uniform clinical trials protocol for use in manufacturer-sponsored research to substantiate user-benefit claims in applications to the Food and Drug Administration (Walden, 1997). I appreciate his interest in this matter and hope that his comments will spark additional discussion.
Byrne argues that the adoption of a uniform protocol probably would not serve its intended purpose. Before I respond to his comments, it might be helpful to describe the context in which my point of view evolved. First, it is important to reiterate that my recommendation for the adoption of a model clinical trials protocol applies only to the specific purpose of substantiating user benefit claims for everyday living in manufacturer applications to the Food and Drug Administration (FDA) (Walden, 1997, p. 14).
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