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

Nature Clinical Practice Rheumatology volume 4, pages 354–355 (2008)Cite this article

Imagine you are a young academic rheumatologist and have a patient with dermatomyositis, who is unresponsive to corticosteroids. A recent, extensive review concludes: “This systematic review highlights the lack of high quality randomised controlled trials that assess the efficacy and toxicity of immunosuppressants in inflammatory myositis.”1 Knowing the relative rarity of dermatomyositis and the improbability of receiving industry support, you embark altruistically on a noncommercial, prospective, randomized, placebo-controlled, multicenter, double-blind, investigator-initiated trial (IIT) to establish the role of methotrexate treatment for this disease. Five years later the trial has not yet started, you have spent many frustrating hours in the labyrinth of the European Union's Clinical Trials Directive 2001/20/EC,2 as well as your own national regulatory authority's rules, and the costs are mounting.

In the past, IITs have generally been simpler than industry-sponsored, commercial, single-product development trials. While these academic trials have followed the ethical principles of the World Medical Association's Declaration of Helsinki, which was first adopted in 1964 and was itself derived from the 1947 Nuremberg Code,3 few clinical investigators are aware that the declaration has in fact been revised five times and clarified twice, and these changes are now under criticism, as recently summarized.4,5

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References

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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.

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  1. Department of Rheumatology, University Hospital, Felix Platter Spital, Burgfelderstrasse 101, 4012 Basel, Switzerland alan.tyndall@fps-basel.ch

Authors and Affiliations

  1. A Tyndall is Professor and Head of the Department of Rheumatology, University of Basel, Switzerland.,

    Alan Tyndall

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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.

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

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