Lupus community panel proposals for optimising clinical trials: 2018

Joan T. Merrill, Susan Manzi, Cynthia Aranow, Anca Askenase, Ian Bruce, Eliza Chakravarty, Ben Chong, Karen Costenbader, Maria Dall'Era, Ellen Ginzler, Leslie Hanrahan, Ken Kalunian, Joseph Merola, Sandra Raymond, Brad Rovin, Amit Saxena, Victoria P. Werth

Research output: Contribution to journalArticle

15 Citations (Scopus)

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.

Original languageEnglish (US)
Article numbere000258
JournalLupus Science and Medicine
Volume5
Issue number1
DOIs
StatePublished - Jan 1 2018

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Clinical Trials
Polypharmacy
Treatment Failure
Noise
Research Personnel
Outcome Assessment (Health Care)
Therapeutics
Pharmaceutical Preparations

Keywords

  • clinical trials
  • outcome measures
  • trial design

ASJC Scopus subject areas

  • Immunology

Cite this

Merrill, J. T., Manzi, S., Aranow, C., Askenase, A., Bruce, I., Chakravarty, E., ... Werth, V. P. (2018). Lupus community panel proposals for optimising clinical trials: 2018. Lupus Science and Medicine, 5(1), [e000258]. https://doi.org/10.1136/lupus-2018-000258

Lupus community panel proposals for optimising clinical trials : 2018. / Merrill, Joan T.; Manzi, Susan; Aranow, Cynthia; Askenase, Anca; Bruce, Ian; Chakravarty, Eliza; Chong, Ben; Costenbader, Karen; Dall'Era, Maria; Ginzler, Ellen; Hanrahan, Leslie; Kalunian, Ken; Merola, Joseph; Raymond, Sandra; Rovin, Brad; Saxena, Amit; Werth, Victoria P.

In: Lupus Science and Medicine, Vol. 5, No. 1, e000258, 01.01.2018.

Research output: Contribution to journalArticle

Merrill, JT, Manzi, S, Aranow, C, Askenase, A, Bruce, I, Chakravarty, E, Chong, B, Costenbader, K, Dall'Era, M, Ginzler, E, Hanrahan, L, Kalunian, K, Merola, J, Raymond, S, Rovin, B, Saxena, A & Werth, VP 2018, 'Lupus community panel proposals for optimising clinical trials: 2018', Lupus Science and Medicine, vol. 5, no. 1, e000258. https://doi.org/10.1136/lupus-2018-000258
Merrill JT, Manzi S, Aranow C, Askenase A, Bruce I, Chakravarty E et al. Lupus community panel proposals for optimising clinical trials: 2018. Lupus Science and Medicine. 2018 Jan 1;5(1). e000258. https://doi.org/10.1136/lupus-2018-000258
Merrill, Joan T. ; Manzi, Susan ; Aranow, Cynthia ; Askenase, Anca ; Bruce, Ian ; Chakravarty, Eliza ; Chong, Ben ; Costenbader, Karen ; Dall'Era, Maria ; Ginzler, Ellen ; Hanrahan, Leslie ; Kalunian, Ken ; Merola, Joseph ; Raymond, Sandra ; Rovin, Brad ; Saxena, Amit ; Werth, Victoria P. / Lupus community panel proposals for optimising clinical trials : 2018. In: Lupus Science and Medicine. 2018 ; Vol. 5, No. 1.
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