Clinical Trials for Pharmaceuticals: Design and Development

This course addresses the practical issues in the design of pharmaceutical trials and protocol development, as well as broader issues relating to the interface of clinical trial design with overall drug development.

• Address the ethical considerations involved in conducting clinical trials
• Strategically plan for successful clinical trials
• Develop trial objectives and hypothesis testing
• Develop protocols in accordance with regulations
• Evaluate basic statistical issues relating to sample size
• Distinguish and utilize assessment instruments

• Staff from Pharmaceutical Companies or Contract Research Organizations (CROs) who will be involved in the design of clinical trials and have responsibility for protocol development
• Project Managers who have little or no clinical trial experience
• Project Team Leaders who will be designing clinical trials
• Clinical, Regulatory, and Development Staff who would like to learn how to design a clinical trial program
• Investigators who would like to learn how to design a clinical trial and about protocol development

The course will be led by one of the following instructors:

Edith A. Zang, Ph.D.

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• Ethical Issues
• Case Studies: Improving Clinical Trials
• Control Groups
• Group Assignments
• Rationale Evaluation
• Protocol Modifications
• Sample Size
• Study Objectives

Day 1: 8:30 a.m. – 5:00 p.m.

• Historical Overview: Overview of the regulatory process; general ethical considerations
• Clinical Investigational Plan: Strategic planning; special clinical trial opportunities; clinical trial simulation
• Phases of Drug Development: Phase I and II; Phase IIIa and IIIb; Phase IV
• Regulations and Guidelines Pertaining to Clinical Trial Design: USA; Europe; Japan; “Rest of the World”
• Impact of the ICH on Clinical Trials: Principles of ICH GCP; clinical trial protocol and protocol amendments; statistical principles; clinical trial reports; structure and content

Day 2: 8:30 a.m. – 5:00 p.m.

• Clinical Trial Design: Definitions; types (controlled and ethical considerations uncontrolled); relative and absolute efficacy; placebo controversy; (ethical considerations)
• Protocol Structure and Format: Subdivisions of individual sections
• Patient Populations: Inclusion and exclusion criteria; sub-population choices
• Sample Size: Qualitative endpoint; quantitative endpoint; establishing equivalence; rare events; single group
• Trial Objectives and Hypothesis Testing: Single versus multiple; a priori and posteriori hypothesis testing; assessment instruments (number and sensitivity; variations for centers in multicenter studies; pharmacoeconomic and quality of life considerations)

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.

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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-10-005-L01-P. Released: 10/10.

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.