| Abstract: | Since the first properly randomized control trial of streptomycin for pulmonary tuberculosis in the late 1940s, society has made great advances in combating bacterial infections and in developing vaccines to prevent such infections. One constant challenge that anti‐bacterial clinical development must grapple with is to determine the potential benefit of newer agents over existing agents, in an era when anti‐bacterial resistance is a constantly shifting target. By contrast, the development of anti‐fungal agents went into high gear only in the late 1980s and early 1990s in an effort to manage fungal infections in cancer patients receiving chemotherapy, especially in patients with haematologic malignancies, bone marrow transplantation, or lymphoma. The pursuit of anti‐fungal agents intensified with the AIDS epidemic. The evaluation of anti‐fungal agents often faces complications brought on by competing risks in situations where the underlying infections are associated with a high chance of mortality or severe morbidity. In this paper, we use four case studies to illustrate some of the challenges and opportunities in developing anti‐bacterial and anti‐fungal agents. The illustrations touch on not only statistical issues, but also issues related to the availability of new anti‐bacterials in the future. Some suggestions on how statisticians could take advantage of the opportunities and answer to the challenges are also included. Copyright © 2005 John Wiley & Sons, Ltd. |
