How Vault CDMS Streamlines Data Collection for Oncology Trials

Data Collection
Vault EDC is designed to minimize the challenges of data collection in oncology trials by simplifying the patient journey, guiding site’s through error-free data entry, and creating easier processes for local labs.

Simplifying complex patient journeys
Complicated patient journeys make for complicated CRFs, but the proper use of dynamics will alleviate that issue. In Vault EDC, the system will dynamically instantiate the necessary visits and forms as the site enrolls patients. In effect, the system guides the site’s data collection by generating the visits and forms only when they are needed. To accomplish this, the study designer will create a single dynamic treatment cycle, which contains the superset of options, (e.g. all routes of administration, or dosing schedules). The dynamic rules then automatically ensure that patients in each cohort get the relevant visits, forms, and fields for their treatment protocol. Dynamics control cycles, event groups, labels, and many other key functions.

RECIST
Response evaluation criteria in solid tumours (RECIST) is a set of published rules that define when tumours in cancer patients improve (“respond”), stay the same (“stabilize”), or worsen (“progress”) during treatment. As data managers, we issue countless queries on RECIST forms, trying to reconcile tumour assessments from one visit or cycle to another. In Vault EDC, we are tackling these challenges by enabling users to create different collection solutions – focusing on a chronological approach (e.g. assessment by visit) or by tracking the tumour / lesion across visits – in essence treating RECIST data like a log page. We also observe that the options available for measurements and assessments vary with methodology, meaning we need to verify some of the key individual entries. Again, simple built-in logic guides the user effectively through data entry and will catch simple entry mistakes at the source.

Local lab ranges
Oncology studies rely heavily on local labs. The struggles of obtaining and managing the multitude of normal ranges are well documented. Traditional EDC magnifies these challenges by using ranges on a study-specific basis only. There is no automation to reuse ranges across studies.

Vault EDC has addressed this by aggregating management of local lab ranges at the Vault level, enabling appropriate and controlled re-use across all your studies. When collecting data, Vault automatically calculates the patient’s age and applies the appropriate range. To handle exceptions, sites can make study-specific updates or override ranges where applicable (e.g., for short-term use of temporary equipment).

Traditional EDC systems also rely on data management to normalize and convert data for extractions. This is typically performed through a broad set of custom functions. In Vault EDC, we have created productized conversions, reducing the need to program data transformations and rules. Applying these standard conversions expedites data review and reduces the number of edit checks required. Study teams perform one check and auto-convert the data as needed.

Vault EDC is a unique system that simplifies data collection, helping to ensure data is captured correctly the first time. Data-driven dynamics actively guide site personnel to where data collection is needed and minimize the number of clicks required. Learn how Veeva Vault EDC can increase agility in your oncology trials.

See how Vault EDC supports decision-making in oncology trials.