Data Management & Biostatistics

Endpoint Data Capture Strategy: 4 Questions for Sponsors

For a Clinical Endpoint Committee (CEC) to make important decisions, it needs the data to do so. That’s why developing an effective and reliable endpoint data capture strategy is a vital part of working with a CEC. Before starting a clinical trial, sponsors should be able to answer these questions.

1. What needs to be defined?

Endpoints of interest must be defined and standardized as precisely as possible. It’s important to keep in mind that different terminology and standards of care vary around the globe — and an endpoint data capture strategy’s job is to translate them. Endpoints should be mapped to all potential event terms across all study sites and defined in the Clinical Investigation Plan. Investigator and site training on identification and reporting requirements for suspected endpoints should be planned as early as possible. Additionally, the sponsor must ensure that the required criteria for endpoints needing adjudication is clearly defined in relevant study materials.

2. What methods will be used to support accurate detection and reporting of all suspected endpoints?

Investigators are typically the primary monitoring source for endpoint data, as they have direct contact with the patient. After identifying a suspected endpoint, the investigator must complete an appropriate Endpoint Reporting Case Report Form. Your data capture strategy should include a standard triggering process for investigator referral of endpoints for adjudication, as well as a standard query or coding system to ensure no endpoints are missed.

The sponsor may rely also on the support of an internal safety officer or team for collecting blinded anonymized source data and reports from study sites necessary for the creation of CEC files. Secondary and tertiary detection methods — such as monitoring and edit checks and reconciliations — should also be considered. If a suspected endpoint is discovered through these means, it should first be presented to the investigator, who will assess whether or not it should be passed along to the CEC. In such cases, the sponsor can also submit the suspected endpoint for adjudication.

Additionally, controls should be put in place to prevent any clinical trial team member from deleting or restricting review of suspected endpoints. This helps to ensure that all suspected endpoint data reaches the CEC and helps to mitigate bias.

3. How will the suspected endpoint and adjudicated outcome data be handled within the overall study data capture plan?

Best practices specify that sponsors should put in place a designated Endpoint Adjudication Form, which CECs use to document outcomes. The overall study data capture plan should include a procedure to match Endpoint Reporting Case Report Forms with Adjudication Forms. This creates a data link crucial for final reconciliation between suspected endpoints and their adjudicated outcomes.

4. What methods will be used to ensure that all final adjudicated outcomes are complete and current?

Centralized adjudication happens throughout the lifespan of a trial. That means CEC members make their decisions based on data extracted at a particular point in time. However, additional accumulated data that may impact CEC decision making, or additional source documentation may be found after adjudication has taken place. To account for these cases, sponsors need to implement an effective process, specifically one that accommodates data changes requiring re-adjudication.