Risk-based monitoring could significantly modernize and streamline clinical trials

data clinical trials (Idaho National Laboratory http://www.flickr.com/photos/inl/)

TransCelerate BioPharma Inc, an independent non-profit organization focused on accelerating the research and development of new medicines, has released a paper that outlines a standard approach for risk-based monitoring that can be adopted to any clinical trial, regardless of type, phase and stage (Press Release). The approach is designed to enhance patient safety and ensure quality clinical data, and could significantly modernize and streamline the way studies are conducted and monitored in the future.

“Biopharmaceutical companies often spend an extraordinary amount of effort monitoring clinical trials – data from each patient, for every study, at every global site, is reviewed – yet, there isn’t much evidence to indicate that this level of review is effective at identifying systemic errors or substantially improving the quality of data gathered,” said Dalvir Gill , PhD, Chief Executive Officer of TransCelerate, in a press release.  “Despite this, monitoring approaches have remained unchanged.  In this position paper, we have outlined a methodology – procedures, algorithms, a toolkit – for risk-based monitoring that we believe will be effective and efficient for our member companies and others.”

Current monitoring processes rely on source data verification (SDV), but the TransCelerate toolkit shifts the monitoring processes away from SDV and towards comprehensive risk-driven monitoring. TransCelerate’s recommendations are driven by centralized and off-site monitoring techniques, as well as adaptive on-site monitoring, allowing researchers to mitigate risks and detect any issues early.

“TransCelerate’s RBM methodology provides the framework and tools to manage clinical trial risks through identification, categorization and appropriate mitigation.  We are providing tools like the RACT (Risk Assessment and Categorization Tool) and the IQRMP (Integrated Quality and Risk Management Plan), which will help companies identify and plan their risk mitigation strategies.  We also are sharing an approach that enables a balance between off-site/centralized study monitoring and on-site activities at the investigative site.  This allows for a more targeted approach,” said Rehbar Tayyabkhan, Executive Director at Bristol-Myers Squibb and RBM Project Lead for TransCelerate.

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TransCelerate was formed in 2012, and its members include AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche, Sanofi, Astellas Pharma Inc., Biogen Idec, Braeburn Pharmaceuticals, EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Forest Research Institute (a subsidiary of Forest Laboratories, Inc.) and Onyx Pharmaceuticals.

What do you think? Do you think the recommendations will help enhance patient safety and clinical data from trials? Why not join our discussion on LinkedIn, or leave a comment below.

If you want to know more about drug safety and addressing the key challenges for safety professionals, you might be interested in attending the World Drug Safety Congress Europe 2013, 10-12 September 2013, London.

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