TGN1412: The Drug Trial that went Wrong
A – Discuss the short-comings of the TGN1412 clinical trial?
B – Summarise the regulatory changes (in particular the EMEA CHMP SWP 2007 guidelines) that were introduced following the TGN1412 incident and explain how then aim to reduce the risks of ‘first-in-man” trials.
Support your discussions with relevant peer-reviewed publications where appropriate and include a list of references.
Word limit is 2000 words (+/- 200 words) in total for Parts A & B combined.
Please include the total word count (excluding references) on the title page.
Example of referencing format below and please note policy on plagiarism
Students are reminded that copying other people’s work (including text, figures or tables) without citing the source and author is plagiarism, a form of cheating. The assignment should be phrased in your own words and should result from your own intellectual input. Students that do not credit the source of their information, or who acquire parts or the entirety of their assignment from a contracted/commercial agent, or who copy significant sections of work verbatim from other sources (even if the source is cited), will receive no marks.
Plagiarism is defined as follows:
Plagiarism is the use of other people’s work in an assignment and presenting it as your own without explicitly acknowledging – or referencing – where it came from. Plagiarism can also mean not acknowledging the full extent of indebtedness to a source. Work can be plagiarized from many sources – including books, articles, the internet, and other students’ assignments. Plagiarism can easily occur unconsciously or inadvertently. Direct copying is also plagiarism. Paraphrasing of other work without attribution is also plagiarism. Submitting someone else’s unattributed or less than fully attributed work or ideas is not evidence of your own grasp of the material and cannot earn you marks.