Well-planned and well-executed clinical trials are the cornerstones of effective drug and medical device development. Offered in an accelerated format and taught by leaders in the biopharmaceutical industry, this course provides a unique opportunity for professionals from all disciplines to learn about the many facets of clinical trials--the complex process that ensures the safety and effectiveness of medical products.

Participants leave the program with an appreciation of the drug and device development process; as well as good clinical practice (GCP) and other regulations (ICH and FDA) that guide the conduct of trials and protect human volunteers. Also covered are clinical trial phases and design strategies; the importance of informed consent and the role of the IRB; investigator selection and responsibilities; study site management and trial monitoring; statistical data analysis; and regulatory responsibilities and the role of the FDA.

This course benefits anyone working in the biopharmaceutical and medical device industries and the biomedical community who is interfacing with or conducting clinical research, including new clinical research associates and study coordinators, medical directors, physicians, nurses, pharmacists, and other health professionals, biomedical scientists, statisticians and database administrators, and business professionals.

A team of clinical research experts, including many instructors from the UCSC Extension Clinical Trials Design and Management Certificate Program, address the following:

Topics include:

• Drug and Medical Device Development Processes
• Clinical Trial Design
• Applied Statistics in Clinical Trials for the Non-Statistician
• Regulation of Clinical Research
• Roles and Responsibilities of Key Clinical Research Players
• Monitoring Clinical Trials
• Clinical Data Management
• Clinical QA, Auditing and Compliance
• GMP and the Transition to Full Scale Manufacturing
• Business of Clinical Research
• Globalization of Clinical Research

Agenda:

Monday March 11, 2019 – 8:30 am—12:30 pm

Drug Development Process 4 hours – Edward Rozhon

• Major players in drug development
• Assay development and discovery of new medical entities
• Non clinical and clinical development of new drugs
• History and regulatory oversight of FDA
• Structure of Phase I, II, & III clinical trials
• FDA review of New Drug Application

Monday March 11, 2019 – 1:30 pm—5:30 pm
Science of Clinical Trials Design 4 hours – Romi Behbehanian

• Phases of drug development
• Objectives of clinical studies
• Basic clinical trials designs
• Underlying science for clinical trials designs
  

Tuesday March 12, 2019 – 8:30 am—12:30 pm
GCP & ICH Investigator & Clinical Research Site 4 hours – Narinder Singh

• Historical and legislative roads to Good Clinical Practices (GCP)
• Principles of GCP and the research-care conflict
• Role of various stakeholders in Clinical Trials
• Elements of informed consent
  
  

Tuesday March 12, 2019 – 1:30—3:00 pm

Study Site Perspective 1.5 hours – Gerri O’Riordan

• Translational research in an academic center: fundamental strengths and weaknesses
• Research Process and Operations management as the success of a trial
• Essential conversations between academia, biomedical and pharmaceutical companies, venture capitalists and consultants
• Data Integrity and well-supported metrics (Case Studies)
  
  

Tuesday March 12, 2019 – 3:15 pm—5:30 pm

Applied Statistics in Clinical Trials 2.25 hours – Pete Shabe

• The role statistics plays in clinical research
• Basic data summarization techniques
• Estimation and Hypothesis Testing Introduction
• Estimation and Confidence Intervals
• Statistical Hypothesis Testing
  
  

Wednesday March 13, 2019 – 8:30 am—12:30 pm

Monitoring Clinical Trials 4 hours – Savita Sinha

• Review the basic regulatory requirements of monitoring a clinical research study
• Describe the tasks that should be performed before, during, and after a monitoring visit
• Learn how to track all key parameters involved in monitoring a site
• Know how to complete visit reports and follow-up on action items after each site visit
  
  

Wednesday March 13, 2019 – 1:30 pm—5:30 pm

Medical Devices, An Overview 4 hours – Clarisa Tate

• What is a medical device, a general overview of regulations
• Medical devices regulatory pathways: 510(k), PMA, and HDE
• Medical device clinical trials: Focus on Investigational Device Exemptions
• Post-market surveillance: Focus on 522, complaints, and recalls
• Globalization and changing regulatory environment
  
  

Thursday March 14, 2019 – 8:30 am—12:30 pm

Clinical Data Management 4 hours – Amanda Whalen

• Key data management activities for study startup, conduct, and closeout
• Regulations applicable to data management activities
• Clinical data management systems and electronic data capture (EDC)
• Working with contract research organizations (CROs) for data management
  
  

Thursday March 14, 2019 – 1:30 pm—5:30 pm

Clinical QA/Compliance Audits and the FDA 4 hours – Frances Ann McKenney

• Qualifications needed for GXP auditors and FDA Inspectors
• Objectives of sponsor audits and regulatory inspections
• Similarities and differences between sponsor audits and regulatory inspections
• General approach to hosting an audit or inspection
• Types of findings that cause concern for auditors or inspectors

Friday March 15, 2019 – 8:30 am—12:30 pm

Good Manufacturing Practices and regulatory trends 4 hours – Narinder Singh

• Good Manufacturing Practices (GMP) for drugs
• GMP for biologics and related products, including Good Tissue Practices
• Considerations for Quality Systems

Friday March 15, 2019 – 1:30 pm—3:00 pm

Global Clinical Trials Perspective 1.5 hour – Narinder Singh

• Trends in global clinical trials
• Role of FDA and local regulatory culture

Friday March 15, 2019 – 3:15 pm—5:30 pm

Business of Clinical Research 2 hours – Maria Filippou-Frye

• The Market Players – Pharma, Biotech, Contract Research Organizations (CROs)
• Cost of Doing Business – Cost of conducting clinical research
• Outsourcing and CROs – It costs money to make money
• Innovative Ways to Reduce Cost – Business Strategies and Process Innovations