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EFGCP–EUCROF Joint Workshop Final Report   by  on 2010-08-20 20:12:20
Managing Clinical Trials   by  on 2010-07-16 00:05:32
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification   by  on 2010-06-13 18:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by  on 2010-06-13 18:07:59
Rising Clinical Trial Complexity Continues to Vex Drug Developers   by  on 2010-06-03 17:36:33
Investigator-Driven Clinical Trials: An ESF Forward Look   by  on 2010-06-03 17:27:58
NIH's Financial Conflict of Interest (FCOI) Proposed Rule   by  on 2010-05-27 19:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population   by  on 2010-05-13 19:39:54
Argentina: ANMAT - new regulatory update   by  on 2010-05-01 09:40:32
The Wall Street Journal's special supplement on clinical trials   by  on 2010-05-01 09:31:52
Major developments in EU Clinical Trial Guidances   by  on 2010-04-21 03:10:55
Analysis of the adverse reactions induced by natural product-derived drugs   by  on 2010-04-19 07:16:06
Newer Antibacterial Drugs for a New Century   by  on 2010-04-19 06:49:47
Newer Non-Statin Drugs for Reducing Cholesterol   by  on 2010-04-13 15:57:20
Practice Guidelines for Chronic Pain Management   by  on 2010-04-05 04:52:16
CONSORT III (2010)   by  on 2010-03-29 20:53:28
US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function   by  on 2010-03-20 20:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials   by  on 2010-03-04 22:07:46
US FDA new rule on reporting information regarding falsification of data   by  on 2010-02-26 04:47:33
US-FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials   by  on 2010-02-06 20:12:14
 Subject :US-FDA issues First Draft Guidance on Noninferiority Trials.. 2010-03-04 22:07:46 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
Posts: 62
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Dear Friends,
 
The FDA has proposed the first draft guidance on noninferiority (NI) clinical trials, which may help increase the availability of comparative information on drugs. NI trials compare a new drug with a proven drug to determine whether the new drug is less effective by an unacceptable margin. The major focus of the guidance is determining the NI margin, which must be estimated based on past performance of the active control drug and by comparing other test conditions to the current environment, according to the draft guidance. Comments are due May 30.
 
Kind regards,
 
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