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The Different Phases of Clinical Trials

Medical Writing Team

The development of investigational new drugs (INDs) involves performing clinical trials (or studies) to assess the safety and efficacy of the IND in humans.  These trials are usually classified into 4 phases of development (Phase 1 to 4), with each potentially lasting for several years.  Successful completion of each phase and approval by the appropriate regulatory authority or authorities (the European Medicines Agency [EMA] in the European Union, Food and Drug Administration [FDA] in the United States, Health Canada in Canada, or the Ministry of Health, Labour and Welfare in Japan) is required for progression to the next phase.

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Topics: Pharmacokinetics and Pharmacodynamic, Phase I Studies, Pre-Clinical Study, Clinical Trial Phases, Phase 3 Studies, Phase 4 Studies, Phase 2 Studies

Data Transparency in Clinical Trials Q&A with Ben Goldacre [Video]

Statistical Consultancy Team

Q&A on Data Transparency in clinical trials with Dr Ben Goldacre, Katherine Hutchinson & Kevin Carroll at Clinical Data Live!

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Topics: Regulatory Requirements, Good Clinical Practice (GCP), FDA, Adverse Events (AEs), Historical Data, European Medicines Agency, Ethics, Phase 3 Studies, Accessible Data, Phase 4 Studies, Data Transparency

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