Skip to main content
Log in

Why do we need noncommercial, investigator-initiated clinical trials?

  • Viewpoint
  • Published:

From Nature Clinical Practice Rheumatology

View current issue Sign up to alerts

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Choy EH et al. Immunosuppressant and immunomodulatory treatment for dermatomyositis and polymyositis. Cochrane Database Of Systematic Reviews 2005, Issue 3. Art. No.: CD003643. 10.1002/14651858.CD003643.pub2

    Google Scholar 

  2. The European Parliament and the Council of the European Union (2001) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities L121: 34–44

  3. Markman JR and Markman M (2007) Running an ethical trial 60 years after the Nuremberg Code. Lancet Oncol 8: 1139–1146

    Article  Google Scholar 

  4. Goodyear MD et al. (2007) The Declaration of Helsinki. BMJ 335: 624–625

    Article  Google Scholar 

  5. Carlson RV et al. (2004) The revision of the Declaration of Helsinki: past, present and future. Br J Clin Pharmacol 57: 695–713

    Article  Google Scholar 

  6. Kelleher F (2004) The pharmaceutical industry's responsibility for protecting human subjects of clinical trials in developing nations. Columbia J Law Soc Probl 38: 67–106

    PubMed  Google Scholar 

  7. Edwards JC and Cambridge G (2001) Sustained improvement in rheumatoid arthritis following a protocol designed to deplete B lymphocytes. Rheumatology (Oxford) 40: 205–211

    Article  CAS  Google Scholar 

  8. Wagner-Bohn A et al. (2007) Implementing Good Clinical Practice in two noncommercial phase II studies in children with cancer. Onkologie 30: 21–26

    PubMed  Google Scholar 

  9. Halpern SD et al. (2002) The continuing unethical conduct of underpowered clinical trials. JAMA 288: 358–362

    Article  Google Scholar 

Download references

Acknowledgements

The author would like to thank Zoe Doran of the European Group for Blood and Marrow Transplantation for sharing her extensive knowledge and experience in this field.

Author information

Authors and Affiliations

Authors

Ethics declarations

Competing interests

A Tyndall is chairman of the European League Against Rheumatism (EULAR) Standing Committee for International Studies Including Therapeutic Trials (ESCISIT), co-chair of the EULAR and European Group for Blood and Marrow Transplantation (EBMT) hematopoietic stem cell trial in scleroderma, acting chair of three National Institute of Allergy and Infectious Disease Data and Safety Monitoring Boards for stem cell transplantation in autoimmune diseases and his department is participating in commercial studies with Novartis, Roche and Bristol–Myers Squibb.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Tyndall, A. Why do we need noncommercial, investigator-initiated clinical trials?. Nat Rev Rheumatol 4, 354–355 (2008). https://doi.org/10.1038/ncprheum0814

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/ncprheum0814

  • Springer Nature Limited

This article is cited by

Navigation