The world of decentralized clinical trials (DCTs) and risk-based quality management is evolving rapidly – but CluePoints and our partners are here to help you stay abreast of the latest developments.
John Hall, the company’s Senior Vice President for EU and APAC, will lead a session on de-risking DCTs at this year’s Drug Information Association (DIA) global annual meeting, sharing insights on ensuring effective oversight of the dimensions of risk and the quality of participant self-generated data.
Running from June 19 to 23 in Chicago, USA, DIA 2022 will bring industry, regulators, academics, and patients together to discuss the challenges facing the life sciences community and co-create solutions. It is the first time the meeting will be held in person since before the COVID-19 pandemic.
DCTs and Risk
DCTs and hybrid trials are increasing in popularity, not least due to their ability to expand access while boosting patient centricity, recruitment, and retention. However, by relying on patient-reported data, they can also introduce risk into the data oversight process. Poor quality data erodes the validity of a clinical trial, introducing roadblocks to the drug development pathway and wasting the organization’s limited time and resources.
The answer is centralized monitoring or the statistical analysis of real-time data as it accumulates. By providing program-wide oversight, it can quickly identify atypical data, giving study organizers the opportunity to investigate and rectify issues such as fraud, sloppiness, training needs, or faulty equipment before they have a chance to impact the trial’s outcome.
Yet implementing such wide-reaching change into often long-established procedures, particularly as guidelines and recommendations continue to evolve, can be a matter of more accessible said than done.
Understanding a New Paradigm
During the Understanding the Dimensions of Risk and Maximizing Data Quality in Decentralized Trials session at DIA 2022, a panel of experts will help sponsors and CROs demystify the centralized monitoring model.
Hall will be joined by Patrick Nadolny, Global Head of Clinical Data Management at Sanofi, Richard Young, Vice President of Vault CDMS Strategy at Veeva Systems, and Lynne Cesario, Senior Director and Lead of Pfizer’s Risk-Based Monitoring Program, to discuss the current and future landscape of decentralized research, the various sources of risk in DCTs, and how to mitigate them.
The panel will also demonstrate how centralized monitoring technologies can deliver effective oversight, ensure the quality of participant self-generated data, and maximize patient engagement.
To find out more about the session, which will run from 11 am to noon on Wednesday, June 22 in room 176, visit here.