Underberg M any areas of business and gov- ernment are heavily saturated in regulatory requirements
throughout their daily operations. The field
of research — especially in oncology — is no
exception, and regulatory requirements are
present in every aspect of conducting clinical research. Regulatory compliance can be
very cumbersome and resource intensive,
encompassing all phases from opening a
new trial, to approval from the Institutional
Review Board (IRB), assigning a principal
investigator, managing the consent process, and from enrolling patients to study
close-out. In fact, the regulatory burden is
so complex that most research sites struggle
with the daily management of regulatory
compliance. In a survey conducted in 2015
by a joint Initiative from the American
Society of Clinical Oncology (ASCO) and
the Association of American Cancer
Institutes (AACI), 47% of respondents
indicated a lack of adequate staff to
handle regulatory burdens, and 41%
lacked adequate staff for monitoring
regulatory compliance.1 It is of utmost
importance to maintain regulatory
integrity in accordance with the federal guidelines to ensure clinical trial
requirements are being met.
In oncology clinical research,
regulations are put forth and ultimately overseen by the Food and
Drug Administration (FDA). The FDA
requires oversight by an IRB that has
the authority to review protocols at
the site level and approve or disapprove research from being carried out
at a particular institution. The main purpose
of the IRB is to ensure that patient rights
are protected. 2 IRBs and research sites must
adhere to the principles of Good Clinical
Practice (GCP), which is universally recognized as a critical requirement in conducting
research involving human subjects.
by Alaina Underberg, MHSA, CCRP and Christina Head, MHSA
How to open oncology clinical
trials: Staying compliant
» Regulatory tasks in healthcare, especially in clinical research, are a necessary but laborious job that encompasses all
aspects of daily operations.
» Good Clinical Practice (GCP) is a universal set of principles that are recommended and essential in the field of research.
» The IRB and the research site are responsible for ensuring patient’s rights are protected when conducting
» To be in accordance with FDA regulations, it is of utmost importance to maintain regulatory integrity by ensuring
clinical trial requirements are met.
» It is important to have a structured process throughout all phases of opening and maintaining oncology clinical trials.
Alaina Underberg ( firstname.lastname@example.org) is Research Business Manager
and Christina Head ( email@example.com) is Oncology Clinical Initiatives
Analyst at Nancy N. and JC Lewis Cancer & Research Pavilion at
St. Joseph’s/Candler Health System in Savannah, GA.