Eugene Laska, Ph. D. Nathan Kline Institute for Psychiatric Research New York University School of Medicine

1
Eugene Laska, Ph. D.Nathan Kline Institute for
Psychiatric ResearchNew York University School
of Medicine
Sponsored by Merck Research Laboratories
2
How to demonstrate efficacy of regimen in
chronic pain at week W

• Patients with severe chronic pain on placebo
  often drop out so comparisons to placebo are not
  likely to be valid
• Imputation methods are crude at best and do not
  solve problem
• At least x of the patients on drug D (possibly
  plus prn narcotic) must still be in the trial by
  week W
• Conduct a withdrawal trial i.e., at week W, half
  of the patients on Drug D are randomly reassigned
  to placebo -demonstrate superiority of drug D to
  placebo (in efficacy or narcotic sparing) in week
  W1