| 0:00:00 | hello my name is rigid wall of pitch and i'm the corresponding author for this |
|---|
| 0:00:05 | article subjective and points in clinical trials the case for a blind it independent central |
|---|
| 0:00:11 | review this is almost like disciplinary overview of the field of endpoint assessment committees |
|---|
| 0:00:19 | the objective of the review is to define the u a c |
|---|
| 0:00:23 | and provide an overview of its applicability highlight the critical roles e a c compliant |
|---|
| 0:00:29 | drug development |
|---|
| 0:00:30 | provided process map from designing and conducting a regulatory appropriate e a c |
|---|
| 0:00:36 | and explain the different types of v a c's |
|---|
| 0:00:41 | and end point assessment committee as a blinded assessment of subjective clinical data related to |
|---|
| 0:00:47 | patient safety or efficacy that is independent of the side and sponsor |
|---|
| 0:00:53 | it is also called a c e c or i r c |
|---|
| 0:00:58 | it is often performed because a request for regulatory agency |
|---|
| 0:01:02 | it minimises bias and variability as compared to site assessments and it can increase the |
|---|
| 0:01:09 | probability of an accurate assessment by using sub speciality trained experts |
|---|
| 0:01:15 | and it also allows for |
|---|
| 0:01:17 | uniform independent reviewer training on study |
|---|
| 0:01:21 | it is usually performed when the assessment is a primary or important |
|---|
| 0:01:26 | secondary endpoint up in advance clinical trial |
|---|
| 0:01:30 | let's take a look at a complex e a c study of melanoma |
|---|
| 0:01:34 | in this study the overall tumour burden of the patient needs to be assessed |
|---|
| 0:01:39 | therefore we have a radiological assessment of total nine q training is to remember |
|---|
| 0:01:46 | as well as dermatological assessment of to train us to more burden |
|---|
| 0:01:52 | this is summarised in a crf along with information from biopsies |
|---|
| 0:01:57 | and selected clinical listings |
|---|
| 0:02:01 | as well as a location information |
|---|
| 0:02:04 | and an ecologist is also added to facilitate |
|---|
| 0:02:08 | a gestalt understanding of the patient disposition |
|---|
| 0:02:12 | there are two methodological approaches to conducting and here we see assessment a consensus panel |
|---|
| 0:02:19 | and i'm both maybe their bic are |
|---|
| 0:02:22 | a consensus panel is a model bidirectional group assessment of the patient status |
|---|
| 0:02:29 | this approach has the following important advantages it provides a gestalt understanding of the patient |
|---|
| 0:02:35 | and allows for you a scene data to be |
|---|
| 0:02:38 | digital and nine digital however it has the following disadvantages |
|---|
| 0:02:44 | potential for the assessment to be the result of a group thing process rather than |
|---|
| 0:02:49 | total data driven |
|---|
| 0:02:51 | it's harder to schedule |
|---|
| 0:02:53 | and it's impractical to perform and study training and testing since the technique usually requires |
|---|
| 0:03:00 | independent assessments and the conclusions have limited precision since the result from only a single |
|---|
| 0:03:08 | assessment |
|---|
| 0:03:11 | in contrast the model by reader |
|---|
| 0:03:14 | blind independent central review |
|---|
| 0:03:17 | bic our approach |
|---|
| 0:03:18 | is a one-way hierarchical communication |
|---|
| 0:03:22 | where results of one or more reviewers |
|---|
| 0:03:25 | feed into the next assessment ask can be seen |
|---|
| 0:03:28 | with the radiology pathology and dermatological results |
|---|
| 0:03:32 | going into the oncologist unlike the consensus approach all data from the bic rs need |
|---|
| 0:03:40 | to be digital |
|---|
| 0:03:41 | time or frequency of performing these assessments are not an issue |
|---|
| 0:03:46 | since all the reviewers are independent |
|---|
| 0:03:49 | this assessment review paradigm allows for easy i'm going training and testing and the degree |
|---|
| 0:03:56 | of precision of the assessment can be time traded |
|---|
| 0:04:00 | precision is related to the number of independent reviews the number of assessments is predicated |
|---|
| 0:04:07 | on the potential for bias along with the variability in complexity of the assessment |
|---|
| 0:04:14 | in this study the site assessment of pathology is sufficient |
|---|
| 0:04:18 | whereas a single independent read it is necessary for radiology |
|---|
| 0:04:23 | because of the large continuous tumour burden |
|---|
| 0:04:27 | the dermatological assessments require pretty measurements |
|---|
| 0:04:31 | as well as an independent review with the most precision a double reed and if |
|---|
| 0:04:38 | necessary adjudication read |
|---|
| 0:04:40 | results for the ontology assessment of overall |
|---|
| 0:04:44 | patients status |
|---|
| 0:04:46 | so in conclusion and he c can mitigate subjective assessment of hydrogen at and bias |
|---|
| 0:04:53 | by using a well trained team of experts |
|---|
| 0:04:55 | the precision of the assessment can be tight rated by utilizing different bic are paradigms |
|---|
| 0:05:02 | in the future we expect to see more hearing sees in general |
|---|
| 0:05:07 | and bic r e a c's in particular due to |
|---|
| 0:05:11 | increase in regulatory agency recommendations and advances in colour madison and information systems thank you |
|---|