Effective Action in Oncology Studies

Act

According to Tufts’ latest research on oncology studies, “the number of unplanned substantial amendments made to Phase II and Phase III oncology protocols are 50%-70% higher than observed for other drugs.” Similarly, protocol deviations are higher in oncology trials, especially in Phase II with a mean number of 121.8 deviations vs 75.8 deviations in other areas. Data managers require tools in their EDC that help them respond quickly to the deviations and amendments occurring throughout study execution.

1. Protocol Amendments

Study amendments are frequent and common in oncology; especially in early phase where the intent is to learn with each dose administered. Historically, protocol amendments are challenging to manage and deploy, with considerable re-work and often a migration required. During a migration, traditional EDC systems need to be taken off-line, resulting in significant downtime.
Vault EDC fixes this. The study team can choose to deploy changes prospectively and/or retrospectively, at the study, site, or patient level, granting pinpoint accuracy. No more migrations, no down time, total flexibility. These features speak to the core of adaptive research.

2. Serious Adverse Events

Oncology patients are often very sick and therefore more likely to experience serious adverse events. Forming a direct link between the EDC and safety systems enables researchers to remove paper and email from this time sensitive process. Tracking SAEs is usually a manual process or requires additional system modules.
Veeva created an automated connection from Vault EDC to safety systems, using the industry standard E2B requirements. Productizing the integration reduces variability and obviates the need for complex programming. The simplification eliminates barriers and mishaps during study design and execution.

3. Database Freeze / Lock

Freeze and lock activities are typically complicated in early phase oncology studies. Patients participate in a study for variable timelines and having flexibility around when and what data can be locked is important. Adverse events and medications that can extend over multiple cycles and years should be managed individually. Thus, you may want to lock by cycle, visit, patient, or even by site. Prior to lock, it is important to track data cleaning status at the item or record level, to keep the pace of data cleaning on par with data entry.

Vault EDC enables study teams to clean, freeze, and lock data at the item level. This granularity is very important because it helps teams avoid re-visiting previously reviewed data points. When data is frozen or locked, you don’t need to double-check for changes.

• In Vault EDC, freezing cleaned data still allows data changes where appropriate, while flagging the update in real-time to ensure others have visibility into the change.
• Locking data prevents further data changes. In EDC systems where locking occurs at a form level, changing locked data creates an administrative burden because the unlocking impacts more data than necessary. Vault EDC overcomes this by applying controls at the item level – freeze/unfreeze and lock/unlock at the data point.

Learn how to increase agility in oncology trials with Veeva Vault EDC.