Lesson One- Overview Of Drug Development

CRA Training Program Lesson 1- Overview of Drug Development

Development of Regulations Purity of Drugs

Protecting the Public Partnership with Drug Companies

Defining International Standards 

Good Clinical Practice ( GCP)

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International Conference of Harmonization (ICH)

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Sponsor’s Standard Operating Procedures ( SOPs)

Clinical Development Plan-Phases of Clinical Research 

Phase I 

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Phase II 

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What is the effective dosage?

Phase III 

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Is it safe for humans?

How can we measure its effectiveness?

Phase IV 

Marketing, reviews, publication

Designing the Study  

Randomization Blind test process  

Single blind Double blind

Preparing for a Study      

Develop a protocol Order clinical supplies Develop informed consent materials Develop database Select a site Conduct the study initiation visit

Preparing for a Study – Protocol Development A good protocol should… 1. Define the intended effects and objectives of the study What is this drug supposed to do? 2. Establish eligibility criteria Who is this drug for? 3. Describe the design of the study and the procedures How will we conduct the study? 4. Specify how the subjects will be guarded from known or possible hazards How can we protect the subjects? 5. State the endpoints used to evaluate the response How will the effects of the drug be measured? 6. Indicate the assessments that will be used to gather data How will the data be collected? 7. Describe the types of analyses used to judge the data How will the results be analyzed?