Perry Cohen, Ph.D. presents Sham Neurosurgical Procedures in Clinical Trials:  Patient Activists’ Perspectives at the NIH conference
Sham Neurosurgical Procedures in Clinical Trials for Neurodegenerative Diseases: Scientific and Ethical Considerations
held on June 30 and July 1, 2010

Page 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9 - 10 - 11 - 12 - 13

Key Issues for Sham Controls

No sham controlled neurosurgical trial has ever succeeded.

• We need to examine the assumptions, the ethical concerns, and the empirical evidence behind this record.

• We need to acknowledge and value the interests and unique perspectives of actual patient and clinical trial participants on the issues.

The outcome of this conference should be a challenge to the scientific consensus that sham placebo groups are necessary. I want to discuss three major topics:

1. The consistent failure of sham controlled trials to meet primary endpoints in pivotal studies, after we can see substantial, lasting  benefits for at least some patients in open label,  phase I trials

2. Possible explanations for failures in terms of:

   1. Research on the mechanisms and actions of placebo responses

   2. Violation of the assumptions  behind the linear experimental model

   3. Research questions to fill the gaps in knowledge about psychological responses to treatment and the interactions among these factors

3. If there’s time I will specify an alternative patient-centered approach that is safer, provides additional information, and is more cost effective

   Go Back       Go Forward

Page 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9 - 10 - 11 - 12 - 13