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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 :PhRMA's New Clinical Trial Guidelines .. 2009-10-05 10:21:30 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
Posts: 62
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Dear All,

Two cheers for PhRMA, which has produced a set of guidelines urging its members to conduct clinical trials in a more fair manner and to stop bribing doctors with fancy trips to the Caribbean.

Three other highlights:

  • Companies are urged not to treat the Third World like a sluice room: Companies are urged to “collaborate with other relevant parties, such as local health authorities and host governments, to address issues associated with the conduct of the proposed study and its follow-up.” Not too onerous. But then, even when a foreign drug trial gets spectacularly screwed up, the financial consequences aren’t too huge.
  • No more conferences in Puerto Rico: “When clinical investigators and their staff are required to travel to meetings in conjunction with a clinical trial, they may be compensated for their time and offered reimbursement for reasonable travel, lodging, and meal expenses. The venue and circumstances should be appropriate for the purpose of the meeting; specifically, resorts are not appropriate venues. While modest meals or receptions may be appropriate during company-sponsored meetings with investigators, companies should not provide recreational or entertainment events in conjunction with these meetings. It is not appropriate to pay honoraria or travel or lodging expenses for those who are not involved in the clinical trial.”
  • No more ghostwriting: “Authors should identify individuals who provide writing or other assistance and disclose the funding source for this assistance.”

Read PhRMA’s new clinical trial rules here.

Bets Regards,

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 Subject :Re:PhRMA's New Clinical Trial Guidelines .. 2009-10-23 11:37:54 
Savana Chandra Shekhar Dora
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Joined: 2009-10-19 16:46:46
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I am very glad to learn that pharma companies have set guidelines to conduct clinical trials in a fairer manner and have also taken steps to stop bribing doctors with fancy trips. These guidelines may become a stepping stone in enhancing the quality and scope in pharmaceutical sector and as well as helps in maintaining transparency in the overall process.

 
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Last Edited On: 2009-10-23 11:37:54 By Savana Chandra Shekhar Dora for the Reason
 Subject :Re:PhRMA's New Clinical Trial Guidelines .. 2009-10-26 10:00:00 
Sree
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Joined: 2009-09-18 20:04:52
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Thank you for the information on PhRMA guidelines
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