Useful links on clinical trials
- ICH guidelines
(ICH
=International Conference on Harmonisation)
efficacy evaluations in clinical trials. Guidelines E3, E6, E8, E9, and
E10 are of particular interest from a statistical viewpoint.
- Comprehensive list of CDER
(Center of Drug Evaluation and Research) general guidance documents.
- Statistical Guidance on
Reporting Results from Studies Evaluating Diagnostic Tests; Draft
Guidance for Industry and FDA Reviewers.
- Statistical Approaches to
Establishing Bioequivalence.
- GUIDELINE FOR
THE FORMAT AND CONTENT OF THE CLINICAL AND STATISTICAL
SECTIONS OF AN APPLICATION.
- Pharmacology/Toxicology
Draft: Statistical Aspects of the Design, Analysis, and
Interpretation of Chronic Rodent Carcinogenicity Studies of
Pharmaceuticals.
- CDER Homepage: Office of
Biostatistics. Regulations,
Guidances and Manual of Policies and Procedures (MAPPs), Presentations,
Publications.
- OFFICE OF BIOSTATISTICS AND
EPIDEMIOLOGY: CBER (website)
- Points to
Consider on Multiplicity Issues in Clinical Tials. Points to
Consider on the Choice of Non-Inferiority Margin. Points to
Consider on Adjustment of Baseline Covariates. Points to
Consider on Missing Data. Points to
Consider on Application With 1. Meta-Analyses 2. One Pivotal
Study. Points
to Consider on Switching Between Superiority and Non-Inferiority.
Taken from EMEA: The European Agency for Evaluation of Medicinal
Products Evaluation of Medicines for Human Use: Committee for Medicinal
Proprietary Medicinal Products (CPMP).
- Note for
guidance on the Investigation of Bioavailability and
Bioequivalence.
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