Study Type: Randomized, Parallel Assignment
Initiator: Clinflows on behalf of University Medical Centre Mannheim, Heidelberg University, John Uiters
Official Title: A Multicenter Randomized Phase III Trial on Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme (INTRAGO II)

John Uiters is a clinical researcher with over 20 years of experience in oncology. Currently he is involved with the INTRAGO II study on behalf of ClinFlows, a two-year long global study on Glioblastoma Multiforme (GBM) an aggressive type of brain cancer [1]. The study plans to include over 300 patients and based from the Department of Radiotherapy, University Hospital Mannheim in Heidelberg, Germany. The incidence of GBM is two or three individuals per 100,000 and treatment is surgery followed by radiation or chemotherapy where the aim is to remove the tumor and minimize the amount of damage to the surrounding area [1]. With sites around the world such as Australia, Canada, Peru, Spain, and the United States, a single electronic data capture (EDC) system was needed that could be used by all researchers. To meet the needs of the research team, the EDC system needed to be able to reviewed internally by the clinical staff.

 

In the INTRAGO II study, during surgery the radiotherapy applicator is inserted into the brain cavity delivering internal radiotherapy directly to the site. Previous studies have shown this technique to be effective, even doubling the survival rate. If implemented in the treatment protocol, inter-operative radiotherapy may not only extend life, but will also have a positive impact on the quality of life of individuals and their families.

Having heard positive feedback on Castor from a colleague in Rotterdam, John decided to use Castor EDC. He was impressed with how user-friendly the system was and that unlike other systems on the market, there was two-factor authentication, randomization, and monitoring built-in for a fraction of the cost.

“This this a great benefit as the budget of investigator initiated studies normally won’t allow extensive monitoring of entered data.” – John Uiters


Within Castor, John used advanced calculation fields to create multivariate validations and dependencies across forms. By placing “Add Report” buttons in the regular study forms, he captured Imaging review results with the unscheduled forms (known as a
Report in Castor). Each site uploads the images via an imaging portal, a quality control check is completed (de-identification, review of patient identifiers and missing sequences). Then the images are transferred to a viewer for assessment. The study design used stratified randomization (four strata) with two arms and notifications were created alerting users to events in the system.

John explained selecting an electronic data capture system begins with an evaluation of the features, its ease of use and ability to review data. When running a multicenter study, the study monitor needs to be able to view all the activity at each site, often a very administrative and time consuming job. With Castor, study monitors can keep tabs on all participating sites, review data entry and create queries on an ongoing basis from anywhere in the world.

John on-boarded his research team himself using a self-made manual which he tailored specifically for data entry. He told us that the general manual was more geared towards study builders. We always appreciate feedback and are working on developing a data entry focused guide. Best of luck on your study!

Sources:
1.http://www.aans.org/patient%20information/conditions%20and%20treatments/glioblastoma%20multiforme.aspx

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