Phase I First-in-Man Studies: What is Special About How and Where These Trials are Conducted?

Why Should You Attend:

The first time an Investigational Medical Product (IMP) is given to human subjects great care must be taken by all concerned, especially the Principal Investigator, in choosing the appropriate starting dose and thence the right dose escalation to accurately determine the pharmacokinetics as well as the safety of the IMP being studied.

Phase 1 and 2a of the Drug development process are conducted in very special units that in addition to subject amenity areas have immediate access to an EMS area, access to a GLP laboratory and a functioning EDS. In these CPU/CRU’s numerous studies are carried out on normal human volunteers (with notable exceptions) to define the pharmacodynamics and pharmacodynamics in a variety of situations So the dose range and safety is known prior to studies in patients in Phases 2b and 3.

The topics covered in this webinar will provide invaluable assistance to investigators and their staff in regulatory or legal responsibilities and also highlight the ethical considerations in drug or device research involving human subjects.

Learning Objectives:

• Contrast the Testing of pharmacokinetics and pharmacodynamics
• Differentiate the importance of safety testing in Phase I and III
• Describe and summarize the process of establishing the starting dose
• Defend the primacy of the Research Protocol and explain why the PI is responsible for following it to the letter

Areas Covered in the Webinar:

• The Investigators key role in the clinical research process?
• What is special about a Phase I Unit (CPU / CRU)
• The timeframe of the Drug Development process?
• How the dosage for a First–in-man determined?
• What is the “MABEL” approach?
• How is the Dose Response relationship determined?
• The questions to be answered in Phase I studies?
• The expectations of “First-in-Man” studies?
• The role of the “Investigators Brochure”
• The processes of dose escalation
• The conclusions expected from Phase I

Who Will Benefit:

The following professionals from pharma and biotech companies, contract research organizations, research sites, hospitals and university research groups will benefit from this training:

• Principal Investigators and sub investigators
• Clinical Research Scientists (PKs, Biostatisticians)
• Safety Nurses
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• Recruiting staff
• QA/ QC auditors and staff
• Clinical Research Data managers.

Charles H Pierce
Independent Consultant , Pierce One, Consulting

Charles H. Pierce, MD, PhD, FCP, CPI Has 27+ years experience in the Clinical Research field. He now brings the message (via webinars, lectures and seminars) of Risk Management through knowledge of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. He has been involved in Investigator and staff GCP training, and medical monitoring in both drug and device studies.

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