Approved Drug Pulled for Safety Concerns

Approved Drug Pulled for Safety Concerns essay assignment

Review and discuss an article related to an approved drug that was pulled from the market for safety concerns. You will be partnered with a colleague from this course for review of the paper. Each student will complete their project and submit it for review by the instructor. In addition, you will share your paper with your student partner who will do a peer review of your paper and comment on your paper. You will be assigned a student peer. Once you have completed your peer review return it to your partner as well as to the instructor.

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The FDA reviews the data collected in clinical trials to determine whether a drug or device is safe and effective for marketing approval. Complete and accurate data is essential to ensuring consumer safety once a drug or device has been approved for market. Even after thorough review of the data collected, drugs are occasionally approved for market that end up being pulled because of significant adverse events and death. For this assignment find an article on a drug that was approved by the FDA for market and then pulled due to safety concerns (AEs, SAEs, deaths). Go back and review data and information you can find on the clinical trials conducted for the drug. Look at the data that was collected, AEs and SAEs, study findings, reports, etc. In a 4 – 6 page, APA formatted paper summarize and discuss the article including the following information:

Summarize the article and discuss why the drug was pulled from the market.
Review clinical trial data and information and identify how the data was collected and managed.
Was there a Data Monitoring Committee (DMC)? Summarize the DMC safety findings. If there was no DMC, why?
Discuss, based on information collected, whether the events that occurred after the drug was marketed that required pulling the drug, could have been determined during the clinical trial phases.
What could (if anything) the sponsor have done differently?

Rubric- EVERY DETAIL IN THE RUBRIC MUST BE INCLUDED

APA Formatting/Grammar
- Uses correct APA format with minimal errors, minimal spelling/grammar errors. Includes a minimum of 5 appropriate references to support work.
Summary of Article including data collection & management
- Summary provides a clear description of the paper, outlining the problems with the drug, the data on AEs and SAEs, and why it was pulled from the market. Content is supported with 3-5 appropriate references.
Data Monitoring Committee – discussion of safety findings or if no DMC why was it not used.
- Describe the DMC including make-up (members) of the committee, data reviewed by the committee, how often the committee met to review, and the DMC findings. If no DMC explain why it was not needed based on the risks of the trial.
Discuss how post AEs and SAEs might have been determined/discovered during the clinical trials.
- Describe in detail the safety data collected in the trials and the trial outcomes. What AEs and SAEs were reported? Did any safety reports include AEs and SAEs that were found in the general population that resulted in pulling the drug? What was missed during the trials? What additional data might have been collected based on reported AEs and SAEs?
What could the sponsor have done differently?
- Provide 2 – 3 things the sponsor might have done differently that might show the AEs and SAEs reported post study.

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Approved Drug Pulled for Safety Concerns