Endpoint Adjudication

Add a Higher Level of Certainty to Your Clinical Trial Safety and Efficacy Assessments

Inconsistency or bias can seep into trial data in some fairly common circumstances - When clinical trial endpoints are subjective, image-based or complex to assess... When some study components are unblinded... Or when the trial is a multicenter study across multiple countries with cultural differences. That’s when an independent and objective Endpoint Adjudication (EA) process can help you resolve elements of uncertainty, reduce bias, increase accuracy, and improve data quality and integrity.

The Importance of Endpoint Adjudication in Your Trial

An endpoint is any event that might indicate if the treatment being studied has had either an adverse or a positive effect on the condition being treated - or on the safety of the patient. Determining safety and efficacy depends on accurate assessment of endpoints based on unbiased data. The best way to ensure that accuracy is to introduce an endpoint adjudication process that will be implemented by an independent and objective endpoint adjudication committee. The EA process is the best way proven to eliminate bias, increase accuracy, restore confidence in data and reduce risk to patients. EA “helps reduce the varied outcomes and events - a benefit that can be especially helpful during regulatory review” [American Heart Journal, March 2017, p 78].
However, endpoint adjudication tied to paper processes adds complexity and increases study costs especially because of the onerous and time-consuming management, handling and transfer of paper source documents. It has become clear that endpoint adjudication cannot be efficiently executed without the use of electronic adjudication technology - eAdjudication® software and systems.

eAdjudication for Endpoint Adjudication: Scalable and Cost-efficient Solution

Endpoint Adjudication Committees in Clinical Trials

Endpoint Adjudication committee assessments using the eAdjudication® software and services platform help ensure that trial data is as accurate and free of bias as possible.

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eAdjudication for Endpoint Adjudication

Endpoint Adjudication Regulatory

Before submitting data to the FDA and EMA, we will help you determine exactly what you should have in place.

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Ethical eAdjudication for Endpoint Adjudication

Endpoint Adjudication Resources

We have assembled a useful repository of links to useful resources to you on your Endpoint Adjudication exploration.

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An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals

The objective of this paper, published on Therapeutic Innovation and Regulatory Science  was to analyze how often adjudicated methods across efficacy and safety assessments were used in drug approvals in the EU / USA in 2013 and 2014.

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Endpoint Adjudication: Challenges for Endpoints based on Subjective Assessments

A P-VALUE IS ONLY AS GOOD AS THE DATA: Challenges when Endpoints are Based on Subjective Assessments
When endpoints are based on subjective assessments rather than objective data, a process of centralized endpoint adjudication can improve the quality of a clinical trial.

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Endpoint Adjudication: Effects on Bias, Variability, Sample Size and Study Power

Ethical's Speech at CBI 2016 Event in Philadelphia. Juan Torres, from Sintax For Science, Statistical Expert and Ethical's partner, and Mimmo Garibbo, Ethical Director, introduces the "Effects of Central Adjudication in Bias, Variability, Sample Size and Study Power".

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