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Access to clinical care via clinical trials: is it ethically possible?

Nature Clinical Practice Rheumatology volume 4, pages 166–167 (2008)Cite this article

Access to medication can be limited by governmental regulation and drug approval processes, restrictions to manufacturing or distribution, insurance or pharmacy formulary restrictions, or simply by cost to the patient. Some physicians are in favor of enrolling patients into clinical trials to allow individual patients to access medications that would not otherwise be available to them. Beyond furthering clinical research and providing therapy to patients, incentives for clinical investigators to enroll patients in clinical studies might include potential study reimbursement, authorship, protected time for clinical research and career advancement. Although wider availability of unapproved drugs for use outside of pre-approval clinical trials has also been advocated, it is not the subject of this discussion.1,2

Some physicians argue that enrollment in a clinical trial represents a beneficent or fair approach to a patient in clinical or economic need. This argument hinges on the idea that voluntary informed consent renders potential therapeutic consideration to be of greater importance than concerns regarding the risks of unapproved or unproven remedies, or regarding random allocation to treatment groups within a trial. This therapeutic view of clinical trials as a means to access clinical care does not hold up to close scrutiny, and poses particular ethical challenges for the investigating clinician.

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Acknowledgements

This manuscript was presented in part at the Annual European Congress of Rheumatology, EULAR 2007.

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  1. Division of Rheumatology, Cambridge Hospital, 1493 Cambridge Street, Cambridge, MA 02139, USA promain@challiance.org

Authors and Affiliations

  1. and a Lecturer of Medicine at the Department of Medicine, PL Romain is Chief of Rheumatology at Cambridge Health Alliance, Cambridge, MA, Harvard Medical School, Boston, MA, USA.,

    Paul L Romain

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Romain, P. Access to clinical care via clinical trials: is it ethically possible?. Nat Rev Rheumatol 4, 166–167 (2008). https://doi.org/10.1038/ncprheum0739

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