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Clinical Trials Design

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More Information on the Design of Clinical Trials

  • Letter in Science – Rethinking Clinical Trials: Phase 1 Studies Insufficient, December 9, 2011
  • Testimony: Issues in Clinical Trials of New Drugs for Community-Acquired Bacterial Pneumonia, December 9, 2009
  • Comments on FDA Draft Guidance on Postmarketing Studies and Clinical Trials, October 13, 2009
  • Comments on FDA Draft Guidance on Conduct of Clinical Trials in Community-Acquired Bacterial Pneumonia, June 25, 2009
  • Comments on FDA Draft Guidance for Industry – Drug-Induced Liver Injury: Premarketing Clinical Evaluation, December 24, 2007
  • A Policy Study of Clinical Trial Registries and Results Databases, July 17, 2007
  • Letter in NEJM About Ethical Concerns with Hepatitis E Vaccine Trial, June 7, 2007
  • Comments on FDA Guidance for Industry on Clinical Lactation Studies, April 11, 2005
  • Comments on FDA Obesity Trial Guidelines, April 12, 2007
  • Public Citizen v. FDA (Seeking records on discontinued drugs), January 5, 1994

You might be interested in

Comments on FDA Guidance Regarding IRB Waiver of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects

September 22, 2017

Comments on FDA Draft Guidance on Postmarketing Studies and Clinical Trials

October 13, 2009

Letter in the Washington Post on Death of Jesse Gelsinger in Study

February 14, 2000

Comments on Good Manufacturing Practices for Phase 1 Clinical Trial Drugs

April 3, 2006

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