Clinical Trials Design
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- Comments on FDA Draft Guidance on Postmarketing Studies and Clinical Trials, October 13, 2009
- Comments on FDA Draft Guidance on Conduct of Clinical Trials in Community-Acquired Bacterial Pneumonia, June 25, 2009
- Comments on FDA Draft Guidance for Industry – Drug-Induced Liver Injury: Premarketing Clinical Evaluation, December 24, 2007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