Current Course

UTMB and FDA Educational Collaboration Training Program

UTMB and FDA Educational Clinical Pilot Course:

Achieving Data Quality and Integrity in Clinical Trials Involving High Consequence Pathogens

Course Dates: April 8-10, 2019

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Course Background:

To protect our nation’s security, medical countermeasures (MCMs) for high consequence pathogens (HCPs) is essential to treat and prevent threats to global health. Sixteen years ago, the United States Department of Health and Human Services Food and Drug Administration (FDA) published the final rule for New Drug and Biological Drug Products; Evidence needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible (21 CFR Parts 314 and 601, Federal Register, May 31, 2002). The Animal Rule (AR), as often referenced, states that, “for drugs/biologics developed to ameliorate or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic substances, when human efficacy studies are not ethical and field trials are not feasible, FDA may grant marketing approval based on adequate and well-controlled animal efficacy studies when the results of those studies establish that the drug is reasonably likely to produce clinical benefit in humans”. Because of the highly infectious nature of HCPs, these studies are often performed in high or maximum biocontainment (BSL-3/4). The logistics of assuring accurate and reliable data collected from these environments is challenging. These products are subsequently evaluated through clinical trials during a public emergency. Data derived from the nonclinical AR studies and the clinical studies for HCPs, are reviewed by FDA and global authorities to draw a regulatory conclusion; therefore, data quality and integrity are imperative.

In 2012, the FDA and the University of Texas Medical Branch at Galveston (UTMB) collaborated to design and implement an education program to cross educate sponsors, scientists, veterinarians, physicians, nurses, quality assurance personnel, regulators, reviewers, and policymakers to enable the conduct of regulated studies supporting product approval via the FDA’s AR. These studies require compliance with the FDA Good Laboratory Practice regulations (21 CFR Part 58) to the extent practicable in order to assure data quality and integrity. The result was a robust education program that delivered annual training to 311 registered attendees from 2013 - 2018.

The FDA and UTMB is currently expanding the education program curriculum to include a course addressing the conduct of HCP clinical trials and also to potentially expand the catalog of on-line courses for distance education of individuals conducting HCP clinical trials at remote sites. Knowledge gained will address barriers to progress and increase communication between parties involved in the conduct, policy-making, funding, review, and inspections of studies necessary for the advancement of MCMs and protection of human health.

Pilot Course Summary

This 2 ½ day course is designed to address practical considerations for the planning and operationalizing of clinical research protocols involving medication countermeasures for high consequence pathogens. Faculty include regulatory, clinical, and research staff who have experience conducting field trials while managing patient care in barrier nursing environments.  Included in the curriculum are topics addressing cultural and language barriers, ethical considerations for placebo controlled studies, regulatory expectations, study monitoring, barrier nursing challenges, sample integrity, protocol development, international issues, and stakeholder roles and responsibilities. Integrated scenarios, case studies based on real-life experiences, and expert panels are included along with lectures from subject matter experts from the Food and Drug Administration, the National Institutes of Health, National Ebola Training and Education Center (NETEC), and clinical biocontainment units (BCUs).

Target Audience

Physicians, Scientists, Principal Investigators, Physician Assistants, Nurse Practitioners, Nurses, Pharmacists, Clinical laboratorians, Clinical research staff, Regulators, Policy-makers, Regulatory reviewers, Biosafety professionals, IRB professionals, and Sponsors.

Want to volunteer to attend the clinical pilot course? Click here