Managing Phase I Clinical Trials

Managing clinical trials, of any size and complexity, requires strategic planning and efficient execution. In order to successfully deliver innovative therapies to patients with unmet medical needs the trial management guidelines need to be standardized further, and robust methods of evaluation of study protocol complexity developed in conjunction with risk management strategies. As scientific advances continue, the types of therapies being developed have higher potency and novel targets; and increased pressure to have study designs that speed clinical development. The clinical research industry is changing, and the number of protocols requiring special populations for early-phase clinical studies is increasing.

The primary aims of Phase I Clinical Trials are to determine the safety, tolerability and pharmacokinetics (PK) of a compound. Trials have historically been conducted in the logical sequence of single ascending dose, multiple ascending dose, examination of preliminary effect of food on exposure, and potential drug-drug interaction, with assessments to determine the effect of gender, age, bioavailability and bioequivalence performed as necessary.

First –in-human (FIH) studies now routinely contain several parts with multiple cohorts with increased dose flexibility and accelerated dose escalation paradigms; each of which might have been previously a separate clinical trial. Sponsors, CROs and investigators struggle to minimize risks and avoid serious consequences, and yet, there remains real risk in an FIH study.

Why You Should Attend:

Understating study designs for Phase 1 trials and challenges associated with the use of special populations is critical to ensure that the study design will allow for the timely and successful completion of the project, while minimizing individual exposure to the risks of participating subjects, managing costs, and assessing safety profile.

Course Objectives:

This session will explore the challenges clinical teams face in developing Phase I clinical study protocols to ensure that the right patients are enrolled and that the right data are collected to demonstrate a drug is safe and efficacious, while at the same time managing study costs and study complexity, especially in trials that involve early-phase drug metabolism, imaging and interventional procedures. Key factors to consider, when developing protocols and techniques to minimize complexity, while ensuring trial success, will be discussed. A methodology to identify operational processes at execution phase and best practices to increase fiscal return, mitigate fiscal compliance risks for clinical trials with special population will be reviewed.

Areas Covered in the Session :

  • Understand the FDA requirements for Phase I clinical trials
  • Review of the different Phase I trial designs
  • Discuss Evolving Challenges with early phase studies for Sponsors, CROs, third party vendors and sites
  • Discuss how to optimize protocol design for special population
  • Identify risks in early phase clinical trials
  • Discuss mitigation strategies
  • Address strategic planning and budgetary consideration for Phase I designs
  • Determine critical factors for selecting a Phase I clinical trial site
  • Plan, develop and implement effective Phase I study management strategy
Who Should Attend:

  • Directors of Clinical Operations
  • Medical Affairs specialists and leaders of this division
  • Project Managers
  • Staff from Pharmaceutical/Device Companies or Contract Research Organizations (CROs) involved with the management of clinical trials
  • New clinical or other Project Team Leaders who will be managing projects
  • Clinical, Regulatory, Research and Department (R&D) Staff who will design clinical trial programs
  • Physician investigators
  • Clinical Research Coordinators (CRCs) and Clinical Research Associates (CRAs), Data Managers or others working in biomedical product development and/or interested in transitioning into clinical trials field
  • Grant Administrators
  • Regulatory Affairs
  • Quality Control(QC), Quality Assurance Specialists


Marina Malikova

Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.

Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.

In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.

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  • Presentation Handout in .pdf format
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