Editors
Jeffrey M. Drazen, M.D., David P. Harrington, Ph.D., John J.V. McMurray, M.D., James H. Ware, Ph.D., Janet Woodcock, M.D., Editors
Too long to paste, but here is an excerpt...
Addressing the 12 questions below provides a path forward (Table 1).
IS THERE SOME INDICATION OF POTENTIAL BENEFIT?
WAS THE TRIAL UNDERPOWERED?
WAS THE PRIMARY OUTCOME APPROPRIATE (OR ACCURATELY DEFINED)?
WAS THE POPULATION APPROPRIATE?
WAS THE TREATMENT REGIMEN APPROPRIATE?
WERE THERE DEFICIENCIES IN TRIAL CONDUCT?
IS A CLAIM OF NONINFERIORITY OF VALUE?
DO SUBGROUP FINDINGS ELICIT POSITIVE SIGNALS?
DO SECONDARY OUTCOMES REVEAL POSITIVE FINDINGS?
CAN ALTERNATIVE ANALYSES HELP?
DOES MORE POSITIVE EXTERNAL EVIDENCE EXIST?
IS THERE A STRONG BIOLOGIC RATIONALE THAT FAVORS THE TREATMENT?
