hello my name is rigid wall of pitch and i'm the corresponding author for this
article subjective and points in clinical trials the case for a blind it independent central
review this is almost like disciplinary overview of the field of endpoint assessment committees
the objective of the review is to define the u a c
and provide an overview of its applicability highlight the critical roles e a c compliant
drug development
provided process map from designing and conducting a regulatory appropriate e a c
and explain the different types of v a c's
and end point assessment committee as a blinded assessment of subjective clinical data related to
patient safety or efficacy that is independent of the side and sponsor
it is also called a c e c or i r c
it is often performed because a request for regulatory agency
it minimises bias and variability as compared to site assessments and it can increase the
probability of an accurate assessment by using sub speciality trained experts
and it also allows for
uniform independent reviewer training on study
it is usually performed when the assessment is a primary or important
secondary endpoint up in advance clinical trial
let's take a look at a complex e a c study of melanoma
in this study the overall tumour burden of the patient needs to be assessed
therefore we have a radiological assessment of total nine q training is to remember
as well as dermatological assessment of to train us to more burden
this is summarised in a crf along with information from biopsies
and selected clinical listings
as well as a location information
and an ecologist is also added to facilitate
a gestalt understanding of the patient disposition
there are two methodological approaches to conducting and here we see assessment a consensus panel
and i'm both maybe their bic are
a consensus panel is a model bidirectional group assessment of the patient status
this approach has the following important advantages it provides a gestalt understanding of the patient
and allows for you a scene data to be
digital and nine digital however it has the following disadvantages
potential for the assessment to be the result of a group thing process rather than
total data driven
it's harder to schedule
and it's impractical to perform and study training and testing since the technique usually requires
independent assessments and the conclusions have limited precision since the result from only a single
assessment
in contrast the model by reader
blind independent central review
bic our approach
is a one-way hierarchical communication
where results of one or more reviewers
feed into the next assessment ask can be seen
with the radiology pathology and dermatological results
going into the oncologist unlike the consensus approach all data from the bic rs need
to be digital
time or frequency of performing these assessments are not an issue
since all the reviewers are independent
this assessment review paradigm allows for easy i'm going training and testing and the degree
of precision of the assessment can be time traded
precision is related to the number of independent reviews the number of assessments is predicated
on the potential for bias along with the variability in complexity of the assessment
in this study the site assessment of pathology is sufficient
whereas a single independent read it is necessary for radiology
because of the large continuous tumour burden
the dermatological assessments require pretty measurements
as well as an independent review with the most precision a double reed and if
necessary adjudication read
results for the ontology assessment of overall
patients status
so in conclusion and he c can mitigate subjective assessment of hydrogen at and bias
by using a well trained team of experts
the precision of the assessment can be tight rated by utilizing different bic are paradigms
in the future we expect to see more hearing sees in general
and bic r e a c's in particular due to
increase in regulatory agency recommendations and advances in colour madison and information systems thank you