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Lupus community panel proposals for optimising clinical trials: 2018

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Merrill JT1, Manzi S2, Aranow C3, Askenase A4, Bruce I5, Chakravarty E1, Chong B6, Costenbader K7, Dall'Era M8, Ginzler E9, Hanrahan L10, Kalunian K11, Merola J7, Raymond S12, Rovin B13, Saxena A14, Werth VP15. Lupus Sci Med. 2018 Mar 23;5(1):e000258. doi: 10.1136/lupus-2018-000258. eCollection 2018.

Abstract

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1 Arthritis & Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, USA.

2 Allegheny Health Network, Pittsburgh, Pennsylvania, USA.

3 Autoimmune and Musculoskeletal Disease, Feinstein Institute for Medical Research, Manhasset, New York, USA.

4 Columbia University Medical Center, New York City, New York, USA.

5 University of Manchester, Manchester, England, UK.

6 Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.

7 Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.

8 UCSF, San Francisco, California, USA.

9 Department of Medicine, SUNY Downstate Medical Center, Brooklyn, New York, USA.

10 Research and Education, Lupus Foundation of America, Washington, District of Columbia, USA.

11 Rheumatology, University of California, San Diego, San Diego, USA.

12 Lupus Foundation of America, Washington, District of Columbia, USA.

13 Internal Medicine/Nephrology, Ohio State University Wexner Medical Center, Columbus, Ohio, USA.

14 Rheumatology, New York University, New York City, New York, USA.

15 Department of Dermatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.

Erratum in

Correction: Lupus community panel proposals for optimising clinical trials: 2018. [Lupus Sci Med. 2018]

Abstract

Formidable impediments stand in the way of treatment development for lupus. These include the unwieldy size of current trials, international competition for scarce patients, complex outcome measures and a poor understanding of these outcomes in the world at large. The heterogeneity of the disease itself coupled to superimposition of variegated background polypharmacy has created enough immunological noise to virtually ensure the failure of lupus treatment trials, leaving an understandable suspicion that at least some of the results in testing failed drugs over the years may not have been negative, but merely uninterpretable. The authors have consulted with many clinical trial investigators, biopharmaceutical developers and stakeholders from government and voluntary sectors. This paper examines the available evidence that supports workable trial designs and proposes approaches to improve the odds of completing interpretable treatment development programs for lupus.