The three best practices for successful clinical adjudication

The role of clinical adjudication

Clinical adjudication is a structured process used to validate clinical trial endpoints. An independent committee of medical experts (known as the Clinical Endpoint Committee) reviews the integrity of clinical trial data against predefined criteria, ensuring accurate and consistent data interpretation throughout. This process is particularly important in the face of endpoint complexity, subjectivity, and variability of physician reporting, the effects of which may be especially prominent in multi-center, multi-country studies. Clinical adjudication enhances the reliability of clinical trial findings, ultimately helping to protect patient safety. 

Although clinical adjudication plays a role across a wide range of therapeutic areas, a well-established area of use comes within cardiovascular clinical trials. Commonly adjudicated endpoints are complex, including major adverse cardiac events. These events often rely on a combination of clinical judgment, lab-based biomarkers, and clinical trial imaging, making independent review essential to reduce potential misclassification.

Although there is no universally mandated regulation for clinical adjudication, many regulatory agencies, including the FDA and the EM,A strongly support its use, having come to expect it in certain trial contexts. Best practices for effective clinical adjudication drive consistent datasets, regulatory confidence, and trial integrity. This article aims to outline those best practices in line with Perceptive’s adjudication services so that your trial can benefit from unbiased endpoint evaluation, streamlined regulatory submission, and enhanced data reliability. 

The Perceptive perspective – Start early, integrate deep therapeutic experience, and use established clinical adjudication processes and infrastructure.

The three best practices for successful clinical adjudication

Efficient clinical adjudication within clinical trials involves a number of key practices, including intentional planning, operational discipline, and therapeutic insight. Below are our three best practices for successful clinical adjudication.

1. Start early 

Delaying resource allocation for clinical adjudication can lead to inconsistent data capture, protocol misalignment, and delayed regulatory submission, not to mention time and expense in the latter stages of trial execution if you have to rebuild IT workflows to retrospectively review events. Errors in endpoint selection are extremely difficult to rectify down the line, meaning a clinical endpoint committee (CEC) expert should be retained during the initial stages of trial design and planning.

Benefits of starting early:

• Ensures clinical trial EDC is designed and programmed for the site to report events requiring adjudication, capturing all necessary data fields.
• Ensures events are identified for adjudication as soon as possible after reporting.
• Sites (and the clinical project team) are trained on their roles and responsibilities for clinical event adjudication at the same time they are being trained and initiated on all other trial processes.
• Increases site compliance, decreases query times, and improves source document quality and availability.
• Ensures all clinical event adjudication processes and systems are in place prior to events occurring.
• Provides accurate, up-to-date, real-time event adjudication data to clinical trial team for analysis.
• Prevents backlogs and delayed adjudication results.

2. Partner with a proven provider

While on the surface services across providers may seem similar, experience navigating the nuances of clinical adjudication makes a huge difference to execution and clinical trial timelines. An experienced provider will have well-established relationships with expert adjudicators, scalable workflows, robust data platforms, and a history of delivering high-quality outcomes across global clinical trials.

Finding a clinical adjudication partner with a strong track record and proven experience is not just beneficial, but essential. Look for direct and deep experience not only with the process of clinical adjudication itself but within the therapeutic area of study. Consider whether your provider has clearly established relationships with expert adjudicators who have clinical expertise in the endpoints of interest, as disease-specific expertise enables the adjudication team to apply clinical criteria both appropriately and efficiently. Experts interpret complex cases accurately, and can anticipate regulatory expectations in line with specific therapy requirements. 

Perceptive’s clinical adjudication management team has a combined 60+ years experience managing clinical event adjudication services, supporting the adjudication of over 600K events utilizing a global network of over 250 KOLs and clinical experts, making us an exceptional choice for your clinical adjudication needs. 

3. Align technology and workflow early 

Establishing the clinical adjudication process early is not just about ensuring expertise, it is about having the right infrastructure. Clinical adjudication is not a one-size-fits-all approach, meaning workflows need to be tailored specifically to trail design and therapeutic areas. Endpoint adjudication can be managed within an electronic web-based interface, providing efficiency, accountability, and essential documentation of the entire process, supported by flexible and cohesive technology. Web-based electronic adjudication systems can support secure, role-based access from multiple stakeholders, including CEC coordinators, clinical adjudicators, site investigators, and researchers. 

Perceptive utilizes a web-based EAS compliant with 21 CFR Part 11, designed to reduce the time and resources needed by the event adjudication committee. It optimizes the independent review process while maintaining a thorough audit trail of all activities.

Key features include: 

• Web-based access with 24/7/365 support, offering secure access controlled by protocol, site, user, and role criteria
• Direct uploading of supporting documentation with a redaction tool to anonymize patient identifiers before submission
• Centralized electronic tracking and storage of all visit and source documentation data 
• Real-time, readable audit trails of all actions
• Direct access for event adjudication committee members to view event data, supporting documentation, and record adjudication results
• Customizable review process flow 
• Automatic generation of a final adjudication result for each event, based on the adjudication paradigm outlined in the charter
• Storage of final adjudication results for all events, allowing for direct export to the project team
• Improved committee functionality through superior organization of source information and case dossiers, facilitating a more efficient and thorough review 
• Real-time reporting access to provide transparency into the independent event adjudication review process, keeping the trial team informed in real-time

Perceptive is uniquely positioned to provide clinical adjudication services for your clinical trial.

Reach out today and one of our solution experts will be in touch to learn about your specific needs.