Tegenero AG TGN1412 Clinical Trial

Wikipedia: TGN1412 https://en.wikipedia.org/wiki/TGN1412

The Corporation Citizens For Responsible Care and Research Inc. (CIRCARE). Tegenero AG TGN1412 Clinical Trial. (oa. onderzoeksprotocol, PIF, IMPD en Investigator Brochure. http://www.circare.org/foia5/tgn1412.htm

Richtlijnen & documenten

UK

• Expert Group on Phase One Clinical Trials. 7 December 2006
  (Chairman: Professor Gordon W. Duff). Final report of the Expert Scientific Group (ESG) which was set up following the very serious adverse reactions that occurred in the first-in-man clinical trial of TGN412 in March 2006.
  
• The Academy of Medical Sciences: Testing Antibody Therapies: Position Paper. 5 April 2006
• The Royal Society: Consultation response. July 2006

EMA

• Committee for Medicinal Products for Human Use (CHMP). Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products of 19 July 2007 (EMEA/CHMP/SWP/28367/07).

ICH

• ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals. CPMP/ICH/286/95. June 2009.
• ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals. CHMP/ICH/731268/1998. July 2011.

FDA

• FDA Guidance for Industry Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. July 2005.

Artikelen in nieuws en media (selectie)

• Drug Trial Goes Terribly Wrong: Emergency At The Hospital (Medical Documentary) (11-04-2018). Real Stories, via YouTube. https://www.youtube.com/watch?v=a9_sX93RHOk
• Boseley, S. (15 March 2006). Six men in intensive care after drug trial goes wrong. The Guardian. http://www.theguardian.com/society/2006/mar/15/health.medicineandhealth2
• Horvath, C. J. & Milton, M. N. (24 February 2009). The TeGenero Incident and the Duff Report Conclusions: A Series of Unfortunate Events or an Avoidable Event? Toxicol Pathol April 2009 vol. 37 no. 3 372-383. doi: 10.1177/0192623309332986 
• Roxby, P. (23 May 2013). Northwick Park drug trial disaster – could it happen again? BBC News. http://www.bbc.com/news/health-22556736
• St. Clair, E. W. (2008). The calm after the cytokine storm: lessons from the TGN1412 trial. The Journal of Clinical Investigation, 118(4), 1344–1347. http://doi.org/10.1172/JCI35382
• Wadman, M. (published online 22 March 2006). London’s disastrous drug trial has serious side effects for research. Nature 440, 388-389 (23 March 2006). doi:10.1038/440388a