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There is a significant amount of documentation that must be completed prior to, during, and after an

Questions and AnswersPosted On:2023-07-31 11:03:59Viewed:107

There is a significant amount of documentation that must be completed prior to, during, and after an IND study are completed.  Given the requirements, name one facet that can go wrong during a clinical study conducted under an IND.  Can the chances of this particular instance be reduced with additional documentation?

 

Kindly answer with the references


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Last updated on:2023-07-31 11:03:59

One facet that can go wrong during a clinical study conducted under an IND is the lack of a clear understanding of the research protocol by the study participants. This can lead to misunderstandings in the interpretation of the protocol and the reporting of results. This can be reduced with additional documentation such as clear study instructions, frequent monitoring, clear communication with the participants, and detailed record keeping.
 

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  • New medications and treatments cannot be developed without clinical trials conducted under an Investigational New Drug (IND) application. A substantial quantity of documentation must be completed prior to, during, and after the study to guarantee that it is conducted in a safe and ethical manner. Despite this, there are still a number of potential issues that can arise during an IND-governed clinical trial.

  • The participants' absence of comprehension of the research protocol is one such issue. This can lead to misinterpretation of the protocol and inaccurate reporting of results. As the clinical trial is being conducted under an IND, it is crucial that all participants fully comprehend the study protocol. A lack of clarity can lead to confusion and a failure to adhere to the protocol, which can result in inaccurate results and a possible violation of IND regulations.

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    frequent monitoring, clear communication with participants, and detailed record keeping. Researchers can ensure that the clinical trial is conducted safely and ethically by following these steps.

REFERENCES:

Deaton, A., & Cartwright, N. (2018). Understanding and misunderstanding randomized controlled trials. Social science & medicine, 210, 2-21.

Belch, A., Kouroukis, C. T., Crump, M., Sehn, L., Gascoyne, R. D., Klasa, R., ... & Eisenhauer, E. A. (2007). A phase II study of bortezomib in mantle cell lymphoma: the National Cancer Institute of Canada Clinical Trials Group trial IND. 150. Annals of oncology, 18(1), 116-121.


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