LS&HC Horizons 2023 - Flipbook - Page 15
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Clinical Trials
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Improving clinical trial integrity: lessons learned from GMP
Clinical trial integrity ensures good clinical
practice (GCP), usability of data, and avoids
pitfalls that come with clinical studies,
especially in a decentralized environment
where clinical activities are increasingly
outsourced. While FDA has robust oversight
over pre-approval of clinical trials, annual
reporting requirements, and reporting of
certain quality and safety-related events,
the agency provides little guidance on the
internal reporting mechanisms for deviations
associated with clinical trials. This leads
to differing interpretations and practices
around escalation and handling root cause
investigations with independent oversight.
Failure to establish and follow quality controls
leaves clinical trials susceptible to breaches
of integrity that may be missed, which could
result in clinical trial fraud, harm to patients,
and collection of inaccurate data.
Companies can consider mitigating certain
kinds of these risks by employing good
manufacturing practice (GMP) techniques
to their clinical practices, in order to enable
more robust and compliant clinical studies
for developing biotech products. Among GMP
requirements, a risk-based oversight program
that establishes robust deviation investigation
and escalation procedures can significantly
strengthen clinical trial integrity.
Blake E. Wilson
Partner, Philadelphia
Additional GMP principles can build integrity
and quality around data, especially quality risk
management (QRM) approaches to improve
controls and communication and to facilitate
improvements. Some principles of QRM which
companies should consider include:
• establishing a well-defined governance and
reporting mechanisms that allow for multiple
avenues of reporting that eliminate bias and
information loops;
• prospectively assessing the suitability
and competence of the parties carrying out
clinical trial activities, and monitoring
and reviewing the performance of staff;
• developing well-defined written
agreements for outsourcing of activities,
including tailored contractual language
with investigators and vendors regarding
personnel who will perform the day-today tasks;
• defining responsibilities and communication
processes, including rules describing what
issues must be reported to the managerial
level and a process to report issues to a level
above one’s direct supervisor; and
• identifying deviations and other integrity
concerns and systems to drive improvements
that strengthen clinical trial integrity.
Lowell M. Zeta
Partner, Washington, D.C.
Ashley Grey
Law Clerk, Washington, D.C.
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