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International Clinical Trials

Swimming in Data

Here’s a true story: a CRO is conducting a complex drug compliance study examining varying dosage levels. The trial has finished, and they are closing the database. Then comes a nasty surprise, they run a summary table and find that average drug compliance exceeds 100%. Digging in, they see reports of 600% and 700% compliance in some sites – which is nonsensical, and impossible. They scramble to clean the data. Their data submission is delayed. They lose credibility.

How Could They Not Have Known?

Maybe because they were asking their clinical research associates (CRAs) to filter through a 10,000-line spreadsheet every week – and it is not humanly possible to find all the problems under those conditions. If only they had taken a risk-based approach, using machine learning, those anomalies would have been apparent much sooner. The CRAs would have been looking at just 100 lines in the spreadsheet. Scatterplot graphs would have highlighted outliers. Alerts would have signaled that something was awry. Then, with a little digging, they would have found that site two was inverting the expected doses and the actual doses. They would have cleaned the data and kept the study on track.

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Rhonda Roberts, Senior Data Scientist at Remarque Systems, is a biostatistician by training, and has been in the clinical research industry for 13 years after migrating out of infectious disease hard science. She is passionate about empowering people through the use of their own data.

Kristin Mauri is a Director of Solution Services at Remarque Systems. Kristin brings more than 25 years of clinical research experience and eClinical technology implementation for pharma, biotech, and CRO organisations. Prior to joining Remarque Systems, she was the Global Head of Risk Based Monitoring (RBM) at BioClinica, where she was responsible for overseeing the RBM technology and services practice. A recognised thought leader and industry speaker, Kristin has presented extensively on clinical operations topics in the areas of RBM, quality management, and clinical trial forecasting and budgeting. Her educational credentials include an MBA from Lake Forest Graduate School of Management, MGH Boston Master’s programme, coursework in clinical investigations, and a Bachelor’s Degree from Pennsylvania State University, US.
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