2021 LS&HC Horizons - Flipbook - Page 20
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Hogan Lovells
Clinical trials and the use of technology to monitor AB&C risks
The race to find therapeutics and a vaccine in
the fight against COVID-19 has put the spotlight
back on international clinical trials. Although
international clinical trials are necessary, they
often occur in unfamiliar business and regulatory
environments, requiring pharmaceutical
manufacturers to work with third-party clinical
review organizations (CROs) that have local
expertise. CROs, in turn, often interact with
health care professionals (HCPs) who support
the CROs as clinical trial consultants and/or
investigators, and may be considered “foreign
officials” under the FCPA or other anti-bribery
and corruption (AB&C) laws. In the last two
years alone, there have been hundreds of millions
of dollars in resolutions arising from allegedly
improper interactions with HCPs in connection
with clinical trials.
Embracing technology
Companies are increasingly turning to innovative
risk-management technologies, which can spot
and assess patterns of problematic conduct
quickly and efficiently. Machine learning and
AI in particular can potentially help mitigate
the risks inherent in high risk areas, such as
international clinical trials.
Machine learning algorithms use statistics to find
patterns in large amounts of data, such as:
To date, companies have successfully used
machine learning and AI to:
• assess whether their CRO has compliant
relationships with HCPs, government
officials, and local agencies by analyzing the
nature and frequency of those contacts;
• monitor the timing of CRO-led regulatory
submissions, recruitment of researchers,
and other third-party interactions for
potential AB&C issues;
• fill in gaps and identify potential issues
concerning CRO contracts and payments to
subcontractors or other third parties; and
• spot financial connections between CROs,
subcontractors and government officials.
Embracing emerging technology does not remove
the need for robust, well-staffed compliance
programs, but can allow compliance groups
to make data-driven decisions about what to
investigate and where to focus their training,
auditing, and remediation efforts.
Gejaa Gobena
Partner, Washington, D.C.
gejaa.gobena@hoganlovells.com
• spotting patterns indicative of risky and/or
non-compliant conduct in real time;
• help identify, prioritize, and mitigate risk
areas; and
• streamline compliance monitoring efforts
in regulation-heavy areas such as GDPR.
Sara Silva
Partner, Boston
sara.silva@hoganlovells.com
