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What is ‘clinical trial preparation & planning’ and why is this important in drug development?

Clinical trial preparation and planning includes developing a protocol (action plan) for conducting the research. It describes the what, how and why of the study. Clinical trial preparation and planning also involves determining the eligibility criteria and strategies for participant enrollment. To learn more about clinical trial preparation & planning and why it is important for drug development, click on the links below.

Testimonials: How we did it

Relevant publications

Related Tools

Guides and Training Opportunities

• International Psoriasis Council: Clinical Trial Guide
• IOM: Small Clinical Trials: Issues and Challenges
• Society of Clinical Research Associates: FDA Clinical Trials Requirements, Regulations, Compliance, and GCP Conference

FDA Guidance and Regulations

• FDA: Running Clinical Trials
• FDA: Guidance for Industry – Choice of Control Groups and Related Issues in Clinical Trials
• FDA: Recruiting Study Subjects – Information Sheet
• FDA: Guidance Documents for Institutional Review Boards, Clinical Investigators, and Sponsors
• FDA: FDA Regulation Relating to Good Clinical Practice and Clinical Trials

Tools for Clinical Trial Preparation

• NCI OBBR: Overview of caBIG Tools
• NCI OBBR: caBIG Clinical Trials Suite
• NCI OBBR: caBIG Tools