Basic concepts in clinical trials (Oncology)

 What is the difference between end of treatment and end of study ?

There are two different CRF form page, one for EOT , the other for EOS. 

End of treatment: it is not same as the concept for end of study. End of treatment occurs when subjects are treated and disease progression or lack of tolerability happens.

If a subject who discontinue study treatment for any reason other than PD will be followed for response and survival. Otherwise, the subject will be followed for survival only.


The reasons for end of treatment or end of study may be the same, such as PD,  AE, Death, lost to follow-up, withdraw by subjects, study terminated by sponsor. 



What is TEAE ? How to define them ?

First,

TEAE refers to treatment emergent adverse event.

1. A treatment-emergent adverse event is defined as any event not present prior to the initiation of the drug treatment 

2.  Any event already present that worsens in either intensity or frequency following exposure to the drug treatment. 

Second,

It is an AE occurs on or after the first administration of the investigator's medical product ,which usually starts from D0 to 28days after the last administration.

In addition, Treatment-related SAEs occur at 28days after the last administration will still be considered as TEAEs.

If a subject has not end treatment, any AE start on or after the first dose of IMP will be considered as TEAE.

 

What is Dose Intensity ? What is Relative Dose Intensity ?

Cumulative dose (mg) = Sum of all doses of IMP administered 

Dose intensity (mg/week) = Cumulative dose /Duration of treatment

Relative dose intensity=actual cumulative dose/planned cumulative dose


What is treatment duration ? What is time on study ?

Treatment duration is defined as last dose date of the study treatment – first dose date of the study treatment +1 day

Time on study refers to the time from first dose date of the study treatment to the end of study date. If the subject has not ended study, it is from the first date to the data cut-off date. 

What is the actual arm for the subject ?

In the early phased oncology studies, planned arms may be closed for enrollment when trials are ongoing. Then some of subjects may adjust to the different arms from the planned one. We follow the following rules for the actual arm :

The originally assigned dose/schedule if it was received at least once, or

The first dose/schedule received if the originally assigned dose/schedule was not received

Usually, the actual arm derived by the actual dose the subjects administrated at first time.



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