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Reportlinker Adds Emerging Clinical Trial Locations - India: Market Dynamics and the Changing Healthcare and Regulatory Environment
Date:12/1/2009

ernational agencies 118

Anticipation of approval for early phase studies in India 118

Registration and regulation of CROs in India 119

Future reform and emphasis on improved pharmacovigilance in

India 120

India to implement an electronic management system 120

Outlook 122

Chapter 4 Appendix 124

Introduction to clinical trials 124

Clinical trial phases 124

Phase I 124

Phase II 124

Phase III 125

Phase IV 125

What is a clinical trial 125

Clinical trials of pharmaceutical agents 126

Types of clinical trial 127

Pilot studies 127

Proof of concept (PoC) trials 127

Randomized clinical studies 127

Controlled clinical trials 127

Parallel studies 128

Parallel group trials 128

Cohort studies 128

Case control studies 128

Role of the chief investigator 129

Clinical trial protocol and procedure 129

Determination of the clinical trial size 130

Role of the coordinating centre and trials unit 130

Role of the trial coordinator 130

The trial principle investigator 131

Forms and data management 131

Trial data analysis and evaluation 132

Ethical issues and conduct of clinical trial research 132

Interpretation and publication of clinical trial results 133

Principle regulatory agencies 133

The European Agency for the Evaluation of Medicinal Products (EMEA) 133

The United States Food and Drug Administration (US FDA) 133

Japanese Ministry of Health, Labor and Welfare (MHLW) 134

Methodology statement 135

Primary Data and Information Gathering 135

Secondary data and information gathering 136

Definitions of Product-Life Cycle stages 138


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