BTC 6211 – Final Exam
1. A pharmaceutical company called NUNOVA Pharmaceuticals has developed a new drug for reducing hypertension. The company is sponsoring a clinical trial that involves three sites – Mercy Hospital, University Hospital, and Community Hospital. During the clinical trial, a subject at University Hospital experiences a serious, unexpected adverse event and suffers a cardiac arrhythmia leading to death (15 points).
(a) What should the clinical trial investigator at University Hospital do?
The foremost duty of a clinical investigator is the medical care of the subjects in the clinical trial. In case of serious, unexpected adverse event where a patient suffers from a cardiac arrhythmia leading to death. Following are the …show more content…
• NUNOVA pharmaceuticals must notify the Food and Drug Administration within five business days.
• Also, NUNOVA pharmaceuticals must inform the clinical investigator of the Mercy Hospital and Community Hospital about the incident of death and steps that must be taken in order to protect the other subjects from the adverse events.
• Along with this, the other subjects or their legally authorized representative must be notified by the investigators about the incident of the death as it is the right of the subject to be well informed about the findings of the study as per 21 CFR 50 because that might affect their decision to participate in the clinical study.
2. A randomized clinical trial is being conducted to determine the effectiveness of a new surgical technique. The trial is being conducted at a teaching hospital. The lead investigator on the clinical trial is an attending physician at the hospital, and the investigator is assisted by several surgical residents who evaluate patient outcomes following surgery. Patients receive their group assignments in envelopes; the assignment of each patient to each treatment group is concealed from the residents. During the trial, the residents become curious about which patients are receiving which treatments. The residents begin determining …show more content…
The actions of residents’ is compromise the validity of the clinical study as the validity of the clinical study deals with whether the results of the clinical trials are accurate and reproducible along with whether the results of the clinical trial are useful and applicable to clinical practice. The residents may create biases in providing basic care or by adjusting doses of intervention by deviating from the study protocol. Additionally, the results of a clinical study from a teaching hospital cannot be generalized to a large population or patients coming to the primary care clinics.
(e) Suppose the lead investigator finds out about the residents’ behavior. What should the lead investigator do?
The investigator must document and explain the deviation from the approved protocol to the Investigation Review Board, the Food and Drug Administration and the regulatory authorities.
The investigator must terminate the residents’ training and clinical practice or obtain written agreement from the residents’ with the condition that repetition of such condition may result in termination of residents’ from the teaching
1. A pharmaceutical company called NUNOVA Pharmaceuticals has developed a new drug for reducing hypertension. The company is sponsoring a clinical trial that involves three sites – Mercy Hospital, University Hospital, and Community Hospital. During the clinical trial, a subject at University Hospital experiences a serious, unexpected adverse event and suffers a cardiac arrhythmia leading to death (15 points).
(a) What should the clinical trial investigator at University Hospital do?
The foremost duty of a clinical investigator is the medical care of the subjects in the clinical trial. In case of serious, unexpected adverse event where a patient suffers from a cardiac arrhythmia leading to death. Following are the …show more content…
• NUNOVA pharmaceuticals must notify the Food and Drug Administration within five business days.
• Also, NUNOVA pharmaceuticals must inform the clinical investigator of the Mercy Hospital and Community Hospital about the incident of death and steps that must be taken in order to protect the other subjects from the adverse events.
• Along with this, the other subjects or their legally authorized representative must be notified by the investigators about the incident of the death as it is the right of the subject to be well informed about the findings of the study as per 21 CFR 50 because that might affect their decision to participate in the clinical study.
2. A randomized clinical trial is being conducted to determine the effectiveness of a new surgical technique. The trial is being conducted at a teaching hospital. The lead investigator on the clinical trial is an attending physician at the hospital, and the investigator is assisted by several surgical residents who evaluate patient outcomes following surgery. Patients receive their group assignments in envelopes; the assignment of each patient to each treatment group is concealed from the residents. During the trial, the residents become curious about which patients are receiving which treatments. The residents begin determining …show more content…
The actions of residents’ is compromise the validity of the clinical study as the validity of the clinical study deals with whether the results of the clinical trials are accurate and reproducible along with whether the results of the clinical trial are useful and applicable to clinical practice. The residents may create biases in providing basic care or by adjusting doses of intervention by deviating from the study protocol. Additionally, the results of a clinical study from a teaching hospital cannot be generalized to a large population or patients coming to the primary care clinics.
(e) Suppose the lead investigator finds out about the residents’ behavior. What should the lead investigator do?
The investigator must document and explain the deviation from the approved protocol to the Investigation Review Board, the Food and Drug Administration and the regulatory authorities.
The investigator must terminate the residents’ training and clinical practice or obtain written agreement from the residents’ with the condition that repetition of such condition may result in termination of residents’ from the teaching