Michael Keens and Stefan Michiels, PhD @keensmike @AnjuSoftware @StefanMichiels @GustaveRoussy Keeping Global Clinical Trials Going With Tech

Michael Keens and Stefan Michiels, PhD @keensmike @AnjuSo...

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Clinical Data Management Tools Enables Flexibility and Scalability
Supporting Evolving Oncology Clinical Study Designs

 

OncologyTube was privileged to feature Mike Keens, Executive Vice President, Anju Software (https://www.anjusoftware.com), and Stefan Michiels, Head of Department of Biostatistics and Epidemiology, Gustave Roussy (https://www.gustaveroussy.fr/en).  These gentlemen discussed key aspects of oncology clinical trial enrollment challenges and solutions, especially during and post COVID-19 pandemic.

 

At the outset of COVID-19 during the first quarter of 2020, enrollment within most clinical trials stopped – apart from COVID-19 vaccine trials.  Between March 2020 and May 2020, all ongoing trials scrambled to continue visits at home or attempted to reschedule visits for patients already enrolled during restricted days/hours at facilities that were either locked-down or under restricted hours. 

 

New patient trial activity virtually stopped.  Further, an April 2021 BMC article noted the impact of COVID on clinical trial initiation in the United States, where only 57% of the expected historic average of trial initiations occurred.

 

Gustave Roussy, one of the top 5 cancers centers in Europe, partners with Anju Software to advance its cancer clinical research leveraging the TrialMaster electronic data capture (EDC) and clinical study data management platform. TrialMaster's benefits for Gustave-Roussy include flexibility and scalability supporting evolving clinical study designs such as umbrella, basket, and other platform trials. 

 

The Anju TrialMaster EDC system has contributed to the expansion of Gustave Roussy’s clinical work over the past five years and is ideally suited to the complexities and risks of investigating new oncology compounds. TrialMaster EDC is the most intuitive EDC Suite on the market -- delivering superior usability and flexibility. This innovative software platform is a comprehensive EDC solution for Phase I-IV clinical trials - improving efficiencies and reducing workflow while enhancing data quality, resulting in faster study submission times.

 

In a post-Pandemic environment, the old way of conducting clinical research will be outdated and insufficient.  The industry will evolve into the design and implementation of hybrid and synthetic clinical trials relying heavily on Electronic Clinical Outcome Assessment (eCOA) and Electronic Patient-Reported Outcome (ePRO) platforms. Anju is at the leading edge of data capture with our TrialMaster electronic data capture software. Anju’s EDC is easy to use for both patients and trial sites, which is vital as the market relies more on decentralized trials.

 

Utilizing EDC software platforms has enabled clinical trial sponsors to resume their research programs during the COVID pandemic.  But not all EDC services are positioned to handle the tidal wave of data generated by these digital and synthetic trials.