Clinical Trials Introduction

Clinical Trials :Overview and Opportunities Dr. Kumud Sarin Program Director Bioinformatics Institute of India, Noida

[object Object],Clinical Trials

Different Phases of Clinical Trials ,[object Object],[object Object],[object Object],[object Object]

Phase 0 ,[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],Clinical Trials

Phase IV ,[object Object],[object Object],[object Object],[object Object]

Clinical trials ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Clinical Trial :A Research Study ,[object Object],[object Object],[object Object],[object Object]

Core Components of Clinical Trials ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Core Components of Clinical Trials ,[object Object],[object Object],[object Object],[object Object],[object Object]

The Possible World of Clinical Trial Designs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Simplified ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Study Participant Recruitment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Ethics of Clinical Trials: Protection of Participants ,[object Object],[object Object],[object Object],[object Object]

Ethical Issues: Protection of Human Subjects ,[object Object],[object Object],[object Object]

Human Subjects’ Protection ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Human Subjects’ Protection ,[object Object],[object Object]

Informed Consent: A Part of Human Subject Protection ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Components of Informed Consent ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Vulnerable Populations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Vulnerable Populations ,[object Object],[object Object],[object Object],[object Object]

Participation in Clinical Trials ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Conclusions ,[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object],Contract Research #17 Optimized Lead Molecules Medicinal Chemistry ANIMAL STUDIES: Proof of Concept Animal Pharmacology Animal Toxicity/PK Process Development & Scale-up Human Clinical Trials (Phase I -IV)

Contract Research ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CLINICAL TRIAL INDUSTRY & CAREER PROSPECTS

Indian Clinical Research Industry ,[object Object],[object Object],[object Object],[object Object],[object Object]

Indian Clinical Research Industry ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Clinical Trial Industry Source: Mckinsey Report 30,000 6000 1500 Site – staff Requirement 300,000 50,000 10,000 Patient Load 20,000 4000 800 Full time staff Requirement 875 300 75 Revenue (Crore INR) 1000 200 50 Value (million USD) 2010 2008 2003

Leading Companies in Clinical Trial

List of Major CROs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

List of Major CROs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Increased R&D Focus Shift from business-driven research to research-driven business

[object Object],[object Object],[object Object],[object Object],[object Object],Clinical research Invest in India Contract Research

Invest in India Custom synthesis ,[object Object],[object Object],[object Object],[object Object],[object Object]

Invest in India ,[object Object],[object Object],API sourcing and contract manufacturing

Need for Training Programs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Need for Training Programs ,[object Object],[object Object],[object Object],[object Object],[object Object]

Careers in Clinical Research Clinical Research Associate Clinical Research investigator Study Coordinator Data manager Biostatistician Regulatory Affairs Manager Clinical Trials Auditor Clinical Project Manager Clinical Research Manager Business development Manger Drug Safety Associate Medical Writer

Career Opportunities “ More than 50,000 professionals will be required in the field of Clinical research in India alone.” Source : Mckinsey Report Thus science, pharmacy and medicine graduates can look forward to exciting and rewarding career opportunities in clinical research.

Clinical Trial Quotations “ India is an emerging market with growing number of entrepreneurs foraying into research and healthcare. Indian government is creating an effective regulatory framework. Protection of patents and IPR is now improving. India has a better place than countries like China in the clinical trials field”, Dr Charles Pierce, president Global Clinical Partners, Inc. USA, said Source: Pharmabiz “ Indian contract research Organisations will have good chance to shine, Indian CROs are competitive compared to western companies. There are several advantages to global companies to outsource research service from us”Dr. Goutam Das ,CEO, Syngene International Pvt.Ltd. Source: Chronicle Pharmabiz

Clinical Trials Introduction

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Clinical Trials Introduction