AI clinical endpoint

By Ethical 17 Nov, 2023

Artificial Intelligence holds high promise in clinical endpoint adjudication with eAdjudication (1/2)

At Ethical, we are passionate about new technologies, and we take pride in responsibly leveraging the latest innovations where they can contribute to save time and improve data quality. Over 16 years ago we created one of the very first cloud-based platforms for endpoint adjudication and today we are leading the use of artificial intelligence for clinical endpoint adjudication. In this first article, we will dive into the topic of artificial intelligence in clinical trial data management and clinical endpoint adjudication, discussing the opportunities and the challenges. In the second blogpost we will look at how Ethical customers are already taking advantage of AI technologies to improve data quality while saving time and cost.

Although the use of AI in the field of clinical development is still a relatively new concept, it is already showing promising results. Clinical endpoint adjudication is one of the most active fields, as proven by Ethical for over two years with our eAdjudication® platform. Our tech team shares here some reflections on how AI is impacting data management in clinical trials and endpoint adjudication and discuss the risks and challenges clinical leaders are facing.

In what ways is AI impacting data management in clinical trials?

AI can revolutionize data collection and analysis by allowing researchers to quickly sift through large datasets and reduce human mistakes. Predictive analytics is another active area of AI, as it can be used to examine past trial data to find patterns and predict outcomes. AI can also help researchers manage data quality by detecting irregularities and inconsistencies in large datasets and regulatory documents.

Data collection and analysis: In the past, researchers would spend a great deal of time manually sifting through huge amounts of data, which was both time-consuming and inefficient. Now, AI algorithms are able to analyse large datasets quickly, freeing up researchers to focus on more crucial tasks. 

Predictive analytics: AI algorithms are able to examine past trial data to find patterns and predict outcomes. This helps researchers make more informed decisions about the design and implementation of future trials, and optimize protocols to increase their probability of success i.e. by avoiding design flaws or unnecessary complications.

Data quality control: AI can detect irregularities and inconsistencies in study data, ensuring accuracy and dependability. By spotting errors or outliers, AI algorithms let researchers address issues immediately and make the required changes. This not only improves the quality of the trial, but also lowers the risk of coming to wrong conclusions based on faulty data. In addition, AI can perform an important part of the regular clinical data cleaning, looking for deviations, errors and inconsistencies and generate the appropriate clarification queries. 

In what ways is AI transforming clinical endpoint adjudication?

When it comes to clinical endpoint adjudication, AI can be used to identify suitable patients for a particular trial and handle complex datasets. AI algorithms can also standardize the adjudication process and provide assurance of accuracy and dependability of trial data.

Patient recruitment: By examining electronic health records, social media activity, and other sources of patient data, AI algorithms can predict the frequency and geographic location of patients who could be suitable for a particular trial. This focused approach saves time and resources, as well as guarantees that the correct sites are contacted and the correct patients are enrolled in the study, leading to more precise results and higher chances of success in creating new treatments.

Large data sets: Utilizing AI in clinical endpoint adjudication has the advantage of being able to handle diverse and complex datasets. Clinical trials often contain a variety of variables and assessments, which can be hard to combine in all meaningful ways for a human reviewer. AI algorithms, in contrast, can rapidly and efficiently process this information, make numerous comparisons, find meaningful features and uncover hidden relations.

Standardizing the adjudication process: AI can also help standardize the adjudication process across different trials and research sites. By identifying optimal criteria and settings, AI can make sure that uniformity is maintained in the evaluation of clinical endpoints such as those based on images (MRI, X-ray, CT scan etc). This helps to minimize discrepancies and strengthens the dependability of the results.

What are the risks and challenges of utilizing AI in clinical trials?

In spite of its impressive results, there are risks and challenges to using AI in clinical trials. These include the “black box” operating model of AI which can mask possible bias in algorithms, inadvertently bypass ethical considerations regarding patient privacy and affect the reliability of the validation. 

Possibility of bias: One of the primary worries is the potential for undetected bias in AI algorithms, which can lead to skewed results or incorrect conclusions. To prevent this risk, it is essential to make certain that AI systems are adequately trained e.g. using diverse and representative data sets.

Ethical considerations: There are also ethical considerations concerning the use of AI in clinical trials, particularly in terms of patient privacy and consent. It is vital to observe stringent data privacy regulations and assure that patients comprehend the implications of AI involvement in their trials. This is particularly true when raw health data potentially containing personal identifiers are mined by AI.

Validation: As explained above, there is a need for strong validation methods to guarantee the reliability and safety of AI systems in clinical trial settings. 

Cost: Furthermore, the initial investment and continuing maintenance costs connected with executing AI solutions represent financial risks for organizations conducting clinical trials. It is essential to consider these costs against the possible advantages and carefully analyse the return on investment.

In conclusion, AI offers promising opportunities for improving performance in clinical trials including clinical endpoint adjudication. As with any tool, it is necessary to address the inherent risks and challenges including adapting our ways of working to leverage the full potential of this new technology. Regulatory agencies are adapting to evaluate and accept AI-driven clinical trial processes by developing new standards and guidelines. Please stay tuned for details of how Ethical is safely and responsibly taking advantage of AI in our platforms for clinical trial data management/in our eAdjudication® platform.


eAdjudication® offers such flexibility that the software configuration and support provision are tailored to exactly match your need.

Simplify Endpoint Adjudication with a Platform, AI and Adjudication



Download Ethical eAdjudication for Endpoint Adjudication Dossier

Solution Description


Request a Demo of the eAdjudication® Software Solution

We are EU-GDPR compliant: Your Data will never be used improperly

Event Adjudication Charter Guide

Event Adjudication
Charter Guidebook
Free Download

Previous Next

Migration of legacy adjudication systems: Time for action

In this blogpost, we will explore the limits of manual process for DSMBs in terms of data security and team performance [...]

clinical adjudication softwareREAD MORE

Clinical Adjudication Process Internal Audit: 11 points to verify

What should a sponsor look for when auditing a Clinical Adjudication process? When should the audit be performed? [...]


inspection readinessREAD MORE

Top 5 things data managers should remember in an endpoint adjudication

When clinical endpoints are being adjudicated, an additional source of data is created resulting in additional responsibility for data managers. Below some helpful tips.

Top 5 things data managers should remember in an endpoint adjudicationREAD MORE