Endpoint Adjudication Services for Clinical Trials
Be sure you are working with a trusted partner. Sitero’s Endpoint Adjudication services ensure the results of your clinical trials are consistent, accurate, and unbiased.
What is Clinical Endpoint Adjudication?
Clinical endpoint adjudication is an essential quality control process for the assessment of safety and efficacy of pharmacologic or device therapies in clinical trials. Clinical endpoint adjudication ensures accurate and unbiased evaluation of clinical trial data by applying the expertise of independent medical expert(s). Sitero’s wide network of medical experts and clinicians offer trusted oversight in accordance with the guidelines of the US FDA and EU EMA.
Why is Adjudication Important to Clinical Trials?
Clinical trial adjudication is necessary to ensure that the results of a clinical trial are accurate, reliable, and unbiased. Adjudication is particularly important for clinical trials that involve subjective endpoints or events that are difficult to define or measure objectively. Sitero’s quality driven, systematic, and standardized clinical endpoint adjudication services enhance the validity of trial outcomes, which can make all the difference for a drug’s regulatory approval.
The Benefits of an Independent Event Adjudication Committee
Establishing an independent event adjudication committee (EAC) can offer several advantages to clinical trials, including:
1. Increased Credibility: An EAC can boost the credibility of study results by ensuring that endpoint events are evaluated objectively and independently. This can help to prevent bias and increase the confidence of regulatory agencies, sponsors, and the public in the trial results.
2. Consistent Evaluation: An EAC can ensure that all reported events across the trial are assessed consistently, according to pre-specified criteria, and in a blinded manner. This can minimize variability in data interpretation and enhance the reliability and validity of the trial results.
3. Efficient Endpoint Adjudication: EACs help to expedite the adjudication process by ensuring timely and accurate evaluation of all clinical events, which is critical in clinical trials with time-sensitive endpoints
4. Expertise and Experience: EAC members are comprised of experts in the relevant therapeutic areas and can provide valuable insights into the interpretation of clinical events, improving the accuracy and completeness of the overall study results.
5. Regulatory Compliance: An EAC ensures the trial is conducted in compliance with regulatory requirements and guidelines, which is essential for obtaining regulatory approval.
When do you Need Endpoint Adjudication?
With trials becoming increasing large and complex, the risk of errors and inconsistencies also increases. Endpoint adjudication is necessary in trials where the primary or secondary endpoints require an independent evaluation of events or outcomes to ensure accuracy and validity and eliminate variability in reporting. Some common examples of clinical events that may require endpoint adjudication include:
- Adverse Events
- Disease progression
- Composite endpoints, which combine multiple clinical events into a single endpoint
- Other clinical events that may impact the study outcomes or safety of the participants
Key Factors to Consider When Planning for Adjudication
Clinical trials risk not receiving approval by regulatory authorities if clinical endpoint adjudication isn’t handled correctly. Some key factors that sponsors should always consider when planning for adjudication include:
- Adjudication System: Sitero’s Mentor is a proprietary, electronic, SaaS, web-based software package owned and implemented by Sitero for the use in clinical trials, including streamlining the adjudication process. With Mentor’s capabilities to collect data and provide oversight to reviewers of events, the risk of errors is decreased while increasing accuracy and efficiency. Mentor allows for traceability of every aspect of the process from event identification to review completion, enabling sponsors and CROs to compile complete records and have direct insight for every event.
- Charter: Sitero manages charter creation, gathering input from all stakeholders involved. The charter is a critical document which is intended to provide well-defined procedures of all activities throughout the endpoint adjudication process including scope and applicability, event/endpoint definitions, composition, data handling, record retention and conflicts of interest, responsibilities of all members and stakeholders, dossier compilation, data flow, communications, meetings, and end of study procedures.
- Clinical Adjudication Event Committee: It is critical to select adjudicators with appropriate expertise and experience. Sitero’s global network helps source medical experts that remain independent from the sponsor.
- Identification of Key Stakeholders: The adjudication process involves multiple stakeholders across the sponsor, CRO, and sites. While each project and process vary, Sitero aids in the identification of stakeholders early with clear expectations across all roles defined in the charter.
- Timelines: Taking into account the complexities that come with adjudication clinical events, Sitero establishes realistic and feasible timelines to avoid trial delays while maintaining consistency and accuracy.
- Event Definitions: It is crucial for all endpoints and events requiring adjudication to be well defined, being both objective and clinically meaningful. Sitero ensures all event definitions remain standardized and clear, reducing the risk of ambiguity among adjudicators.
Sitero’s Endpoint Adjudication Services
Sitero’s streamlined adjudication services involves careful planning, managing, and execution. Our Adjudication services include:
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