Trial Registration and Results Reporting on ClinicalTrials.gov

Why Should You Attend:

The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to ClinicalTrials.gov, in accordance with Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801). The Final Rule has been in effect since January 18, 2017.

The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition of the publication of research results generated by a clinical trial. To fulfill this obligation organizations and individuals can provide the World Health Organization (WHO) Trial Registration Data Set required by ICMJE to ClinicalTrials.gov or a WHO primary registry. The ICMJE expects authors to meet all results reporting requirements of their funding and regulatory agencies. If there are no such reporting requirements, the ICMJE encourages authors to submit results information to the same database on which their trials are registered.

In this session we will review the challenges clinical teams and sponsoring organization face in determining if a clinical trials are qualified and required to be registered, what are the parameters as per HHS final rule and NIH policy and discuss time frame for updates to be posted and reporting of the results to be completed.

Areas Covered in the Webinar:

• Discuss key factors to consider, when deciding if its qualified clinical trial
• Review rules, policies and guidelines to identify operational processes and best practices to register clinical trial, provide updates in a timely manner and file final reports
• Review “Summary of HHS Final Rule and NIH Policy on Registration/Reporting in ClinicalTrials.gov” in NEJM (Nov. 2016)
• Provide overview of registration process on Clinicaltrial.gov website

Who Will Benefit:

This training session is designed for entry through intermediate level professionals involved in:

• Regulatory affairs professionals working in biotech, pharmaceutical products and medical device companies
• Medical Affairs
• Project managers
• Clinical Research Associates (CRAs) involved in planning, monitoring, execution of trials and responsible for clinical trial reporting
• Grant managers
• Investigators

Marina Malikova
Executive Director, Boston University School of Medicine

Marina Malikova, Ph.D., MSci, MA, CCRA, RAC - Executive Director, Surgical Translational Research: Operations and Compliance.

Dr. Malikova has over 20 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.

Dr. Malikova has 10 years of teaching experience as an Instructor for Clinical and Biomedical Sciences Program, Metropolitan College. She has developed and taught several courses such as: Design and Conduct of Clinical Trials, Drug Development, Introductory Pharmacology, Clinical Trials Management at Boston University, School of Medicine.

She also served as an Instructor of the Good Clinical Practices (GCPs) course for the Master of Science Program in Clinical Investigation, Division of Graduate Medical Sciences, Boston University, School of Medicine since Summer, 2012.

Dr. Malikova is a member of Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Association Professionals Society (RAPS) and European Society of Radiology (ESR). Currently, she is serving as an Editor for SAGE publishing group and National Institute of Health (NIH) reviewer for grants and clinical trial proposals.

Topic Background:

Registration and summary results reporting of clinical trials has two main purposes: to inform potential subjects, and to increase transparency of conducted clinical trials and the likelihood that negative results of trials will be publicized. The U.S. Government site for registering clinical trials is ClinicalTrials.gov. A study is issued a CT.gov NCT registration number when it is registered. A trial only needs to be listed once. For investigator-initiated clinical trials, the Principal Investigator is considered the Responsible Party, and is the one who has to complete the registration. For multi-center clinical trials, someone other than the local PI usually fulfills this responsibility (i.e. the Sponsor). The Responsible Party who initially registered the clinical trial is also the one who must maintain the information about the trial, including updating recruitment information at least every 12 months and reporting final results.

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