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Reflections on the TEAM Trial: Why Clinical Care and Research Should be Reconciled

  • Jean Raymond (a1)

Abstract

The current clinical and research environment is one that renders any true enquiry into the value of commonly performed surgical acts practically impossible. Drawing from the recent failure of Trial on Endovascular Aneurysm Management (TEAM), a trial on the endovascular management of unruptured intracranial aneurysms, I attempt to identify some principles that sustain the current ways of doing clinical research that have paradoxically become major obstacles to trials that aim to assess the potential benefit or harm due to interventions as currently practiced. Clinical research and practice must coalesce into “clinical care trials” if we are to provide patients with optimal, prudent care in the context of uncertainty. This may require a major change in the mentalities of clinicians, scientists, and patients alike, and the adoption of novel strategies for public agencies to support the integration of clinical research and care.

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Copyright

Corresponding author

Centre Hospitalier de l'Universit’ de Montr’al, Notre-Dame Hospital, Department of Radiology, 1560 Sherbrooke East, Pavilion Simard, Suite Z12909, Montr’al, Quebec, H2L 4M1, Canada

References

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1Raymond, J.Managing unruptured aneurysms: the ethical solution to the dilemma. Can J Neurol Sci. 2009 Mar;36(2):13842.
2Raymond, J, Molyneux, AJ, Fox, AJ, Johnston, SC, Collet, JP, Rouleau, I; the TEAM collaborative group. The TEAM trial: safety and efficacy of endovascular treatment of unruptured intracranial aneurysms in the prevention of aneurismal hemorrhages: a randomized comparison with indefinite deferral of treatment in 2002 patients followed for 10 years. Trials. 2008 Jul 16;9(1):43.
3Raymond, J, Roy, D, Weill, A, et al.Trial on Endovascular Aneurysm Management (TEAM) collaborative group. Unruptured intracranial aneurysms: their illusive natural history and why subgroup statistics cannot provide normative criteria for clinical decisions or selection criteria for a randomized trial. J Neuroradiol. 2008 Oct;35(4): 2106. Review.
4Naggara, O, Whie, PM, Guilbert, F, Roy, D, Weill, A, Raymond, J.Endovascular treatment of unruptured intracranial aneurysms: a systematic review of the literature on safety and efficacy. Radiology. 2010 Jul 15. [Epub ahead of print].
5Byar, DP.Why data bases should not replace randomized clinical trials. Biometrics. 1980;36:33742.

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