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Hi,

Question posted below on behalf of a colleague who would appreciate your advice on this.

Thanks for your help. Cheers,

Leigh-Ann

 

From: Eric Schuur [mailto:[log in to unmask]]
Sent: Wednesday, July 21, 2010 9:29 AM
To: [log in to unmask]
Subject: [AMWA.EDITING-WRITING] Systematic Literature Review Content

 

I am working on a systematic literature review covering clinical studies of a class of medical devices.  The client in this case manufactures one of these devices and wants to use this review as part of a regulatory filing.  The client is asking if we think it would be appropriate to add some information about safety features of the device to the clinical literature review report. 

 

Note that this information is being given to us by the client and is not in the literature.  My guess is that the client wants to emphasize the safety of their device since it is not yet on the market.

 

I have my opinion about this, but don’t have data to support it.  Does any one of you have a feeling about whether including this sponsor-provided info is appropriate in a systematic literature review?

 

Many thanks for your feedback!

 

Eric

 

Eric R. Schuur, Ph.D.

Medical and Scientific Communications

VMWA LLC

www.VMWA.Biz

(650) 224-4178

 

 

 

 

Leigh-Ann Topfer

Coordinator, Information Services

Health Technology & Policy Unit

School of Public Health

University of Alberta

3021 Research Transition Facility

8308-114 St

Edmonton, AB Canada T6G 2V2

phone: (780) 492-9079

fax: (780) 248-1546

e-mail: [log in to unmask]