Clinical trials for oncology are filled with data management complexities that must be carefully navigated, with challenges and solutions outlined in a new case study by CRScube.
Through oncology trials, significant amounts of data are generated from often siloed sources such as individual electronic health records, images from scans, and specific data on the treatments being tested. If conducting decentralised clinical trials or using wearables, further data management complexities are added.
Furthermore, as data is updated throughout the trial, potentially in parallel with disease progression in participants, managing different data sources and tracking queries across systems becomes problematic. Any delays can majorly impact trial outcomes. Depending on the severity of their condition, participants may also have limited time available for the trial duration.
Crucially, data integrity and quality are paramount. If data is incomplete or unreliable, it seriously undermines a trial’s credibility and could result in a failure to progress to the next phase. There may also be a need to restart the clinical trial completely, increasing costs and potentially even requiring a new round of recruitment. A recent report by CRScube highlights the importance of an integrated data flow in complex oncology trials.
Requirements for data management platforms in oncology
When it comes to data management solutions for oncology clinical trials, accuracy and reliability are critical. Alongside this is the flexibility within a platform that can be adapted without delaying trial timelines.
The latest case study by CRScube details what happened when a bio-venture required an electronic data capture (EDC) system with the necessary robustness and flexibility needed to manage its increasing pipeline in oncology activities.
Bio-ventures may also lack the budget and resources of Big Pharma, emphasising the need to optimise costs and streamline processes.
In this particular trial, the sponsor had to overcome several challenges regarding data management and operational issues commonly encountered in oncology studies.
These included the complexities with imaging workflow, which required precise management of the numerous endpoints. A dynamic study design was also needed, given the multiple protocol changes tracking the progression of tumours and lesion complexities.
To address these issues, the team contacted CRScube to request a solution capable of supporting the teams involved with the clinical and radiology reviews, managing functions such as integration of image-based analysis, and providing automation of response calculations.
Throughout all of this was the underlying consideration that workflow flexibility or data quality could not be compromised.
Managing data complexities in oncology clinical trials
The sponsor did have the availability of specialised tools for management of the imaging workflows and the considerable complexities. However, the sponsor selected the capabilities provided by CRScube’s EDC platform to deliver a comprehensive range of functionalities specific to oncology.
The company required RECIST/iRECIST evaluations and treatment structures based on cycles. Crucially, there was a necessity to fully comply with all international regulations and standards.
The company approached CRScube based on the company’s reputation for delivering effective solutions in imaging and independent review workflows.
To learn more about the oncology study, the challenges, solutions, and results for the bio-venture, download the study below.
