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Schizophrenia Bulletin Advance Access originally published online on February 9, 2006
Schizophrenia Bulletin 2006 32(2):225-230; doi:10.1093/schbul/sbj056
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© The Author 2006. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org.

An Industry Perspective on the NIMH Consensus Statement on Negative Symptoms

Larry Alphs1,2
2 Pfizer Global Research & Development

1To whom correspondence should be addressed; Pfizer Global Research & Development, 2800 Plymouth Road, Ann Arbor, MI 48105; tel.: 734 622-4519, fax: 734 622-5240, e-mail: larry.alphs{at}pfizer.com.

Negative symptoms of schizophrenia remain an area of substantial unmet clinical need. By convening a consensus conference in January 2005, the NIMH has taken a leading role in stimulating a resurgence of interest in methodological considerations related to development of new medications for treating negative symptoms. One audience for this work is clinical researchers in industry. They must take ideas, like those emerging from this consensus meeting, and determine whether they can be applied to their global trials in order to meet the needs of a broad group of customers, which include patients, clinicians, regulators, and payers. This article takes the ideas that surfaced from the NIMH consensus work and interprets them in terms of issues that industry faces for its clinical trials. Particular emphasis is given to addressing hurdles to study design and analysis that come when developing broad-spectrum or adjunctive agents that may be effective for negative symptoms.

Keywords: negative symptoms / schizophrenic / trial design


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