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Q: Do clinical trials ever go wrong?

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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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 Subject :New Guidelines on Reporting Industry-Supported Clinical Trial Results:.. 2009-12-04 19:14:15 
GCP HelpDesk
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Subject :New Guidelines on Reporting Industry-Supported Clinical Trial Results: ISMPP

Dear All,
 
Here is the new GPP2 Guidelines on reporting Industry-Supported Clinical Trial Results.

Click here to download the GPP2 Guidelines.

The landmark guidelines on Good Publication Practice (GPP) published in 2003 were developed with the aim of ensuring that “clinical trials sponsored by pharmaceutical companies are published in a responsible and ethical manner.”

To address legislative, guidance, and ethical developments since 2003, and to reinforce the aims of the original document, the International Society for Medical Publication Professionals (ISMPP) convened a Steering Committee to develop a revised Good Publication Practice document to be known as “GPP2”. The committee’s work, GPP2, was independently peer reviewed and published in BMJ (2009;339:b4330).

GPP2 provides comprehensive guidance on a number of key issues, including:

• Roles of authors, sponsors, and other contributors
• Reimbursement and honoraria
• How to establish a publication steering committee
• Role of professional medical writers
• Recommendations for publication planning and documentation
 
Kind regards
IP Logged
Last Edited On: 2009-12-04 19:14:15 By GCP HelpDesk for the Reason
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