Follow us on

Q of the week

Q: Do clinical trials ever go wrong?

Get the Answer: 

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.

Welcome Guest   [Register]  [Login]
EFGCP–EUCROF Joint Workshop Final Report   by  on 2010-08-20 12:12:20
Managing Clinical Trials   by  on 2010-07-15 16:05:32
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification   by  on 2010-06-13 10:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by  on 2010-06-13 10:07:59
Rising Clinical Trial Complexity Continues to Vex Drug Developers   by  on 2010-06-03 09:36:33
Investigator-Driven Clinical Trials: An ESF Forward Look   by  on 2010-06-03 09:27:58
NIH's Financial Conflict of Interest (FCOI) Proposed Rule   by  on 2010-05-27 11:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population   by  on 2010-05-13 11:39:54
Argentina: ANMAT - new regulatory update   by  on 2010-05-01 01:40:32
The Wall Street Journal's special supplement on clinical trials   by  on 2010-05-01 01:31:52
Major developments in EU Clinical Trial Guidances   by  on 2010-04-20 19:10:55
Analysis of the adverse reactions induced by natural product-derived drugs   by  on 2010-04-18 23:16:06
Newer Antibacterial Drugs for a New Century   by  on 2010-04-18 22:49:47
Newer Non-Statin Drugs for Reducing Cholesterol   by  on 2010-04-13 07:57:20
Practice Guidelines for Chronic Pain Management   by  on 2010-04-04 20:52:16
CONSORT III (2010)   by  on 2010-03-29 12:53:28
US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function   by  on 2010-03-20 12:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials   by  on 2010-03-04 14:07:46
US FDA new rule on reporting information regarding falsification of data   by  on 2010-02-25 20:47:33
US-FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials   by  on 2010-02-06 12:12:14
 Subject :PhRMA's New Clinical Trial Guidelines .. 2009-10-05 10:21:30 
GCP HelpDesk
Joined: 2009-06-18 15:31:58
Posts: 62

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,

IP Logged
GCP HelpDesk
 Subject :Re:PhRMA's New Clinical Trial Guidelines .. 2009-10-23 11:37:54 
Savana Chandra Shekhar Dora
Joined: 2009-10-19 16:46:46
Posts: 1
Location: Hyderabad

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.

IP Logged
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 
Joined: 2009-09-18 20:04:52
Posts: 16
Thank you for the information on PhRMA guidelines
IP Logged
Page # 

Powered by ccBoard