SBAR Memorandum: FDA - Clinical Research Protocols and Personnel

This SBAR-style memorandum, prepared by a student, addresses the need for establishing strict protocols for information gathering in a clinical research project related to a novel drug for Sickle Cell Anemia. The memorandum is directed to the FDA Commissioner and outlines the situation, background, assessment, and recommendations (SBAR). The situation highlights the need for improved clinical practice and handling of sensitive patient data as the project moves toward clinical trials. The background describes the promising animal trial results and the design of the upcoming clinical trial. The assessment identifies the need for more personnel and improved organization to handle the increasing workload and paperwork. The recommendation suggests introducing new, adequately trained, and certified personnel who are compliant with ethical and regulatory standards and have signed Non-Disclosure agreements to maintain patient data confidentiality. This assignment is a practical application of the SBAR communication tool within the context of clinical research and regulatory compliance, demonstrating an understanding of the importance of clear communication and adherence to ethical standards in the drug development process.

Running head:SBAR
SBAR-style Memorandum
Name of the Student
Name of the University
Author Note

1SBAR
To: FDA Commissioner Stephen Hahn
From: Name of the Student
Date: Date of Writing the Memorandum
Re: Establishing Strict Protocols for Information Gathering in a Clinical Research Project
S
This is NAME OF THE STUDENT, a researcher working alongside the team on
the development of a novel drug targeted towards patients suffering from Sickle
Cell Anemia. Currently, we have already finished the major stages of the
development process and are heading towards starting the first phase of the
clinical trials (U.S. Food and Drug Administration., 2020). I am writing this
because it is a necessity that we ensure the best possible clinical practice that we
can by combating all the ethical and regulatory issues that we may face during
this process. Since we will be dealing with sensitive patient data, it is imperative
that all standards are maintained. In order to start conducting human trials, a
higher level of standard is required. And while we were designing the trials, we
were faced with the issue of handling the vast number of patient files. Patient
data sheets are getting misplaced, disorganized, and disrupting the process, thus
hindering the efficiency.
B
We have already conducted our animal trials, and the results have proven to be
hopeful. In the sickle cell mouse model (Beuzard, 2008), the novel drug has
shown significant success. This drug, which is a phosphodiesterase nine
inhibitor, has managed to have a high success rate against sickle cell anemia. In
around 80% of the models, we tested the drug on, the sickling of Red Blood
Cells was lowered to a promising 90%. The Clinical Research will be a
randomized control trial that will involve participants above 18 years old. This
will not be blinding the study, and the patients will be fully aware of the
specifics of the drug and which group they are a part of. We have conducted a
pilot study in a small patient group, and the results are somewhat promising.
A
I think that the team that is currently involved with the process is doing a
splendid job, but there is not simply enough of us to adequately handle the larger
scale of the clinical trials. It is also possible that since we are designing the larger
trials as well as conducting the research, the paperwork and organization aspect
of our work is getting neglected.
R
I recommend introducing a significant number of new personnel in the process
of clinical research for the development of this drug. These new people should
be trained adequately, certified as per the necessary requirements, and have been
briefed on the process and aim of the project and has been explicitly approved to
work in this project. They should be empathetic and understanding as they will
be working closely with the participants; they must be supportive as well. Since
these individuals will be dealing with sensitive patient information, they must be
compliant, efficient, and organized. Finally, they must sign a Non-Disclosure
agreement to maintain secrecy and respect patient data.

2SBAR
Reference
Beuzard, Y. (2008). Mouse models of sickle cell disease. Transfusion clinique et
biologique, 15(1-2), 7-11. https://doi.org/10.1016/j.tracli.2008.04.001
U.S. Food and Drug Administration. (2020). Step 3: Clinical Research. Retrieved 3 April
2020, from https://www.fda.gov/patients/drug-development-process/step-3-clinical-
research.