Link To ::
Tegenero AG TGN1412 / EudraCT Number: 2005-003371-21. (1)
Consent Form / Patient Information Sheet. A Phase-I, Single-Centre, Double-Blind, Randomised, Placebo-Controlled, Single Escalating-Dose Study to Assess The Safety, Pharmacokinetics, Pharmacodynamics And Immunogenicity Of TGN1412 Administered Intravenously To Healthy Volunteers. Protocol Number: TGN1412. Parexel Project Number: 68419. Version: 02 Final. 2006-02-09. Available from http://www.circare.org/foia5/tgn1412_consentform.pdf. (2)
Tegenero AG TGN1412 Clinical Trial Application: Release of Information Cover Note. Medicines and Healthcare products Regulatory Agency (MHRA). 2006-04-05. Available from http://www.circare.org/foia5/tgn1412covernote.pdf
Tegenero AG TGN1412 Clinical Trial Assessment Report Pharmaceutical Data. Medicines and Healthcare products Regulatory Agency (MHRA). 2006-01-23. Available from http://www.circare.org/foia5/tgn1412assessment_report.pdf
Tegenero AG TGN1412 Investigational Medicinal Product Dossier Version 1. 2005-12-19. Available from http://www.circare.org/foia5/tgn1412dossier.pdf
Tegenero AG Investigator's Brochure. TGN1412 Humanized Agonistic Anti-CD28 Monoclonal Antibody. Edition 1.1. 2005-12-19. Available from http://www.circare.org/foia5/tgn1412investigatorbrochure.pdf
Clinical Trial Protocol. A Phase-I, Single-Centre, Double-Blind, Randomised, Placebo-Controlled, Single Escalating-Dose Study to Assess The Safety, Pharmacokinetics, Pharmacodynamics And Immunogenicity Of TGN1412 Administered Intravenously To Healthy Volunteers. Version 2.0. Parexel International. 2005-12-21. Available from http://www.circare.org/foia5/tgn1412protocol.pdf
Brent REC Meeting Minutes. 2006-01-23. Available from http://www.circare.org/foia5/tgn1412_recminutes.pdf (3)
Parexel Response to Brent REC re: TGN1412 Application. 2006-02-09. Available from http://www.circare.org/foia5/tgn1412payment.pdf (4)
Parexel Clinical Pharmacology Research Unit, Northwick Park. Trial Listings September 2001 and October 2006. Available from http://www.circare.org/foia5/trial_listingscompared.pdf
Investigations into Adverse Incidents During Clinical Trials of TGN1412. Medicines and Healthcare products Regulatory Agency (MHRA). 2006-04-05. Available from http://www.circare.org/foia5/clinicaltrialsuspension_interimreport.pdf
Press release: Final report on TGN1412 clinical trial. Medicines and Healthcare products Regulatory Agency. 2006-05-25. Available from http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2023822&ssTargetNodeId=389
Press release: Latest findings on clinical trial suspension. Medicines and Healthcare products Regulatory Agency (MHRA) 2006-04-05. Available from http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2023515&ssTargetNodeId=389
Investigations into adverse incidents during clinical trials of TGN1412. Medicines and Healthcare products Regulatory Agency (MHRA). 2006-05-25. Available from http://www.circare.org/foia5/tgn1412rptfinal_20060525.pdf
The Drug Trial That Went Wrong. Brian Deer. Dispatches. Channel 4 Television. 2006-09-28.
URL (Google video): http://briandeer.com/tgn1412/tgn1412-film.htm
Key data 'missing' in drug trial. BBC News. 2006-10-13.
URL: http://news.bbc.co.uk/2/hi/health/6044634.stm
Drug trials and errors. John Naish. The Times. 2006-10-07.
URL: http://www.timesonline.co.uk/article/0,,8122-2390518,00.html
Drug 'administered too quickly.' BBC News. 2006-09-25.
URL: http://news.bbc.co.uk/1/hi/health/5377226.stm
TGN1412 victim given drug 'too quickly.' Brian Deer. The Sunday Times. 2006-09-24.
URL: http://briandeer.com/tgn1412-1.htm
Drug trial rules 'should change.' BBC News. 2006-07-25.
URL: http://news.bbc.co.uk/1/hi/health/5213264.stm
Drug maker files for insolvency. BBC News. 2006-07-04.
URL: http://news.bbc.co.uk/1/hi/health/5146692.stm
Regulators slam drug trial firm. BBC News. 2006-05-25.
URL: http://news.bbc.co.uk/1/hi/health/5015224.stm
Doubt cast over drug trial safety. Susan Watts. BBC NewsNight. 2006-05-24.
URL: http://news.bbc.co.uk/1/hi/help/3681938.stm
Parexel Misled Subjects Sickened in London Study, Ethicists Say. David Evans. Bloomberg News. 2006-04-10.
URL: http://www.sskrplaw.com/publications/060410.html
[No longer available] Parexel International Statement Regarding Tegenero AG Phase I Trial at Northwick Park Hospital, UK. Parexel International Press Release. 2006-04-05. Available from http://www.parexel.com/news_and_events/press_releasesSingle.asp?id=236
Media Advisory Update. Parexel Press Release 2006-05-25: http://www.parexel.com/news-and-events/parexel-news/2006/media-advisory-update1/
Media Advisory Update Parexel Press Release 2006-12-08: http://www.parexel.com/news-and-events/parexel-news/2006/media-advisory-update/
Statements from TeGenero AG. Tegenero AG Press Releases: http://web.archive.org/web/20060614015231/http://www.tegenero.com/news/statement_re_tgn1412/index.php
U.K. Regulators Say Parexel Test Conducted Correctly (Update2). Eva von Schaper. Bloomberg News. 2006-04-05.
URL: http://www.bloomberg.com/apps/news?pid=10000102&sid=aIIUuBzbe5dM&refer=uk
Follow this link to find more news stories about the TGN1412 clinical trial from our March, 2006 news archive
Tegenero AG TGN1412 Clinical Trial Site and Principal Investigator:
Parexel Clinical Pharmacology Research Unit (CPRU), Northwick Park Hospital. Harrow, Middlesex: http://www.drugtrial.co.uk/
Parexel Clinical Pharmacology Research Unit. Trial Listings September, 2001 and October, 2006. Accessed on 2006-10-20 at: http://www.circare.org/foia5/trial_listingscompared.pdf
Parent Corporation / Contract Research Organization (CRO), Parexel International. Waltham, MA: http://www.parexel.com/default.asp
TGN1412 Clinical Trial Sponsor:
Tegenero AG. Würzburg, Germany: http://www.tegenero.com/index.php
Related: Public Summary of Positive Opinion for Orphan Designation of humanised agonistic anti-CD28 monoclonal antibody for the treatment of B-cell chronic lymphocytic leukemia. European Medicines Agency (EMEA). 2005-04-11. Available from http://www.emea.eu.int/pdfs/human/comp/opinion/8595805en.pdf
Research Ethics Committee (REC) for Tegenero AG TGN1412 Clinical Trial:
Brent Medical Ethics Committee. Central Middlesex Hospital. London NW: http://www.nwlh.nhs.uk/research/WebHandbook/Ethicalreview.cfm
UK Research Ethics Committee (REC) Authority:
Central Office for Research Ethics Committees (COREC) and United Kingdom Ethics Committee Authority (UKECA): http://www.corec.org.uk/applicants/contacts/recsrecognized.htm
UK Clinical Trial Regulation, Law, Policy, and Ethical Guidelines:
UK Clinical Trials Regulator: Medicines and Healthcare products Regulatory Agency (MHRA): http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=5
Statutory Instrument 2004 No. 1031 The Medicines for Human Use (Clinical Trials) Regulations 2004 (=Directive 2001/20/EC). Available from http://www.opsi.gov.uk/si/si2004/20041031.htm. Accessibility verified 2006-09-20.
UK Research Policy: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline for Good Clinical Practice (ICH): http://www.ich.org/LOB/media/MEDIA482.pdf
UK Ethical Principles in Human Research: World Medical Association Declaration of Helsinki (2004): http://www.wma.net/e/policy/b3.htm
Goldfarb NM. Informed Consent in the Tegenero TGN1412 Trial. Journal of Clinical Research Best Practices. 2006;2(5). Accessed on 2006-09-20 at: http://www.firstclinical.com/journal/2006/0605_TeGenero.pdf
Goodyear M. Learning from the TGN1412 trial. BMJ, doi:10.1136/bmj.38797.635012.47 (published 22 March 2006). Accessed on 2006-03-21 at: http://bmj.bmjjournals.com/cgi/rapidpdf/bmj.38797.635012.47v1?hrss=1
Suntharalingam G, Perry MR, Ward S, Brett SJ, Castello-Cortes A, Brunner MD, Panoskaltsis N. Brief Report: Cytokine Storm in a Phase 1 Trial of the Anti-CD28 Monoclonal Antibody TGN1412. N Engl J Med 2006; 355:1018-1028, Sep 7, 2006; published at www.nejm.org on Aug 14, 2006. Accessed on 2006-09-19 at: http://content.nejm.org/cgi/content/full/355/10/1018
Expert Group on Phase One Clinical Trials: Final Report. 2006-12-07: http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4141039&chk=Qczxoq
Final Report of the Expert Scientific Group (ESG) December 2006: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_063117
Expert Scientific Group (ESG): Final Report December 2006: Appendix A. Meetings, Papers and Minutes of the ESG: http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_063116.pdf
Expert Scientific Group (ESG): Final Report December 2006: Appendix B. List of invited stakeholders & stakeholder consultations: http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_063116.pdf
Expert Scientific Group (ESG): Final Report December 2006: Appendix C. Stakeholder Meetings Minutes and Presentations: http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_063119.pdf
Expert Scientific Group (ESG): Final Report December 2006: Appendix D. Stakeholder Written Submissions: http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_063120.pdf
Expert Scientific Group (ESG): Final Report December 2006: Appendix E. Comments on Interim Report: http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_063121.pdf
Expert Scientific Group (ESG): Final Report December 2006: Appendices F—L: http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_063125.pdf
Expert Scientific Group on Phase One Clinical Trials: A Consultation. 2006-07-20: http://www.dh.gov.uk/Consultations/ClosedConsultations/ClosedConsultationsArticle/fs/en?CONTENT_ID=4139038&chk=Heo5Fe
Quick links:
Expert Scientific Group on Phase One Clinical Trials: A Consultation. Cover Letter. 2006-07-20: http://www.dh.gov.uk/assetRoot/04/13/75/02/04137502.pdf
Expert Scientific Group on Phase One Clinical Trials (Interim) Main Report. 2006-07-20: http://www.dh.gov.uk/assetRoot/04/13/75/69/04137569.pdf
Expert Scientific Group on Phase One Clinical Trials Appendix I. 2006-07-20: http://www.dh.gov.uk/assetRoot/04/13/76/93/04137693.pdf
Expert Scientific Group on Phase One Clinical Trials Appendix II. 2006-07-20: http://www.dh.gov.uk/assetRoot/04/13/76/94/04137694.pdf
Early Stage Clinical Trial Taskforce. Joint ABPI / BIA Report. 2006-07-04: http://www.abpi.org.uk/information/pdfs/BIAABPI_taskforce2.pdf
The Academy of Medical Sciences. Testing Antibody Therapies: Position Paper. 2006-04-05: http://www.acmedsci.ac.uk/images/project/TestingA.pdf
The Academy of Medical Sciences. Testing Antibody Therapies: Declarations of Interest. 2006-04-05: http://www.acmedsci.ac.uk/images/project/TATDecla.pdf
Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees. Department of Health. 2005-06-06: http://www.dh.gov.uk/assetRoot/04/11/24/17/04112417.pdf
Clinical research in the UK: Towards a single system that delivers distinctive quality and rapid access at reasonable cost. United Kingdom Clinical Research Collaboration (UKCRC). 2005-12-22: http://www.ukcrc.org/PDF/McKinsey%20Study%20Report%20-%20FINAL%20(21%2012%2005).pdf
Good Research Practice (December, 2000) Updated Version – September 2005. Medical Research Council: http://www.mrc.ac.uk/pdf-good_research_practice.pdf
MRC Good Clinical Practice in Clinical Trials. Medical Research Council. March, 1998: http://www.mrc.ac.uk/pdf-ctg.pdf
Notes
1. Tegenero AG TGN1412 clinical trial documents accessed on 2006-04-05 from the Medicines and Healthcare products Regulatory Agency (MHRA) web site at http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2023515&ssTargetNodeId=389
2. Consent form accessed on 2006-04-18 from http://myweb.dal.ca/mgoodyea/TGNConsent.doc. Minor revisions by CIRCARE include correction of typos and reformatting.
3. Source: Open Secrets. Martin Rosenbaum. BBC News Blog. 2006-11-16. Accessed on 2007-07-02 at: http://www.bbc.co.uk/blogs/opensecrets/TGN1412minutes.pdf
4. Source: Open Secrets. Martin Rosenbaum. BBC News Blog. 2006-11-16. Accessed on 2007-07-02 at: http://www.bbc.co.uk/blogs/opensecrets/TGN1412payment.pdf
Last Updated: 2011-06-30
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