While clinical protocols have stringent guidelines for patient participation, there

are still instances where the patient's plan does not meet the required treatment
planning metrics. What aspects may cause a 'deviation unacceptable' outcome?
Why? Provide specific examples.

The primary concern of the governing bodies that monitor clinical trials is that
researchers follow clinical protocols and guidelines. This ensures that the participants’
safety is not jeopardized and holds the researchers accountable. Sometimes,
researchers deviate from their protocol, accidentally or intentionally, and these
instances must be addressed. Some examples of deviations are considered minor, and
include situations where researchers make any change to the protocol, but it does not
affect the data. For example, a patient might need to come into the clinic every other
day for treatment administration. However, once during the clinical trial, they needed to
come two days in a row, due to a scheduling conflict. As long as it does not affect the
treatment outcome, it is a minor change. Another type of deviation would include a time
where the researchers deviate from their original protocol in order to protect the health
and safety of the participant. This could occur if a health emergency requires the
participant to take an unplanned break from the clinical trial. This is an acceptable
decision to protect the research subject, but in order to use the participants' data in the
study, the researchers must inform the IRB about the deviation and receive their
approval. Any deviation from the clinical protocol that affects the participants’ health or
safety, violates informed consent, uses the improper dose/treatment modality, or the
absence of treatment altogether would be considered an unacceptable deviation.

In the context of clinical trials in radiation oncology, there are some more specific errors
that can lead to major or unacceptable deviations. A few examples of these errors
include failing to contour an organ properly (either by including too much or too little),
giving the incorrect dose to OAR which exceed the levels defined in the protocol, failing
to properly delineate the GTV in accordance with the protocol definition, or failing to
deliver the prescription dose to the PTV objective defined in the clinical protocol. If any
of these deviations occur, and the patient is still treated without correction, it is
considered an unacceptable deviation. Following the clinical protocol is so important
because it ensures the safety of the participants. Deviation from this protocol can lead
to increased toxicity, inadequate CTV coverage leading to an ineffective treatment, and
does not align with what the participant agreed upon in their informed consent. All these
issues are a major concern for the health and wellbeing of the research participant, not
to mention that these protocol deviations invalidate the data that has been collected. For
all these reasons, it is crucial that researchers follow their clinical guidelines and
protocols to keep patients safe, maintain indisputable data collection methods, and
provide effective treatments.

References:

Ghooi RB, Bhosale N, Wadhwani R, Divate P, Divate U. Assessment and classification

of protocol deviations. Perspect Clin Res. 2016;7(3):132-136.
doi:10.4103/2229-3485.184817