Page 228 - Safety Risk Management for Medical Devices

Risk Management for Clinical Investigations 207

investigation. The clinical study risks must be analyzed, estimated, controlled, and
evaluated.
When analyzing risks, consider the risks not only to the participants, but also to
the clinicians, investigators, and other persons.
Benefit risk analysis for clinical studies is different from the benefit risk analysis
of commercially released devices in that the point of the study is to demonstrate the
benefit. As such, risk management considers the expected and potential benefits of the
device in the benefit risk analysis.
As part of the risk management of the clinical study, it is expected that a thorough
review of published and available unpublished literature be done to uncover any
known risks that could be relevant to the clinical study.
For a clinical investigation, risks are controlled over two horizons: before an AE,
and after the AE. Before the AE, Risk Controls aim to prevent the Hazardous
Situations from happening. After the AE, Risk Controls aim to limit the harm.
Actions such as patient monitoring, AE reporting, or termination of the clinical inves-
tigation are designed to limit the harm to study participants. The study sponsor should
design and implement appropriate training for the clinical investigators to ensure that
proper data collection, processing, recognition, and escalation activities are performed.
The extent and scope of this training should be based on the severity of the risks, as
communicated from risk management.
Sometimes clinical studies that intend to investigate a new indication for an exist-
ing device use an approved device off label. The additional device-risk which is intro-
duced from the off-label use is counterbalanced by the close clinical monitoring and
safety protocols of the clinical investigation.
Clinical investigations are themselves a component of the risk management process
in that they provide evidence of the benefits, which is used in the benefit risk
analysis.
At the end of the clinical investigation the risk data collected should be reviewed
and fed back into the risk management process for confirmation or revision of the
estimated risks. Also, if any new Hazards were identified during the study, they should
be added to the risk analysis. The benefit risk analysis should be revisited as well for
confirmation or revision.
Any knowledge gained about the potential Hazards and risks of the medical device
should be captured and communicated to the risk management process for use in
future analyses of the risks of the subject device. Also, knowledge gained from the
performance of the clinical investigation and risks that were manifested to the partici-
pants, users, or other persons should be captured and used in future clinical studies.