RT Journal Article
SR Electronic
T1 Lupus community panel proposals for optimising clinical trials: 2018
JF Lupus Science & Medicine
FD Lupus Foundation of America
SP e000258
DO 10.1136/lupus-2018-000258
VO 5
IS 1
A1 Joan T Merrill
A1 Susan Manzi
A1 Cynthia Aranow
A1 Anca Askenase
A1 Ian Bruce
A1 Eliza Chakravarty
A1 Ben Chong
A1 Karen Costenbader
A1 Maria Dall’Era
A1 Ellen Ginzler
A1 Leslie Hanrahan
A1 Ken Kalunian
A1 Joseph Merola
A1 Sandra Raymond
A1 Brad Rovin
A1 Amit Saxena
A1 Victoria P Werth
YR 2018
UL http://lupus.bmj.com/content/5/1/e000258.abstract
AB 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.