Topic: Review and Evaluation of the FDA Reports and Findings for the Clinical Trial Studies
Subject: Medicine and Health
This next major assignment requires you to investigate and research two very important components of the overall Johnson and Johnson Basilea case study.
The first component of your research is to fully understand what the major issues were in the FDA evaluation of the clinical trials associated with Ceftobiprole. In this case it would have been the following:
1. Failure to ensure proper monitoring of the clinical investigations [21 CFR 312.50; 312.56(a)].
2. Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND [21 CFR 312.50].
3. Failure to secure investigator compliance with the investigational plan and applicable FDA regulations [21 CFR 312.56(b)].
4. Failure to ensure that only investigators who were qualified by training and experience were selected as appropriate experts to investigate a drug [21 CFR 312.53(a)].
Secondly, you are to investigate other antibiotics that have been reviewed within the guidelines of the FDA. In this paper, you will integrate these two components in order to develop a well crafted 5-7 page paper that allows you to 1) develop your assessment of the most significant issues (1-4); 2) link these issues to course material and other studies that have been evaluated by the FDA; 3) in order to develop a recommendation that simply identifies the 4-5 most important aspects of the clinical studies that can been aIDressed through improved monitoring activities. As part of this section, you will identify the issue and develop a well-crafted and detailed set of recommendations to improve the trial management activities.