Quality by Design in Clinical Research

In clinical research, “high quality” means that a study generates good, useful data, does not harm the study participants, and proceeds smoothly with few interruptions by errors or omissions. However, too many clinical research studies get mired in a time-consuming quality control (QC) process that generates numerous site monitor findings (e.g., missing data, ineligible study participants, other protocol deviations), data queries, and other after-the-fact indications that a quality problem has been found and needs to be fixed. A research site may be unable to deliver acceptable results, no matter how much the sponsor tries to help. In severe cases, the design of a study incorporates problems that make it impossible to achieve high quality results, no matter how well the study is conducted.

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Clinical Trial Management: Houston, We Have a Problem

In the management of clinical trials, whether they be local, international, multi-site, simple or complex, a variety of situations can (or should I say will) occur that will have you saying “Houston, we have a problem!” These complications may be related to an issue at the clinical site itself, within the CRO or at the Sponsor level, but could also be caused by the study protocol or the investigational drug itself. This white paper will present a methodology to optimize clinical trial management by using best practices, as well as how to avoid and resolve problematic situations that may arise throughout the trial.

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Quality by Design and Risk-Based Monitoring

Over the past decade, the clinical research industry’s standard to meet regulatory monitoring obligations has involved frequent and regular onsite monitoring visits with 100% source data verification (SDV). The belief that “more is better” continues even with new evidence that on-site monitoring practices do not necessarily guarantee patient safety and data quality. An electronic survey was conducted by the Clinical Trials Transformation Initiative (CTTI) in 2008 to assess the clinical monitoring practices utilized across different types of organizations involved in clinical research. The results published in 2011 have highlighted the heterogeneity in monitoring practices between clinical trial organizations, and the key conclusion is that traditional monitoring is inefficient and doesn’t always lead to increased patient safety and data quality in clinical trials.

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