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International Clinical Trials

Trials Limber Up

With sponsors challenged by soaring costs and lengthening timelines, John M Hudak of Criterium, Inc analyses the philosophy and science of ‘agile’ clinical trials

The incorporation of modern technologies in clinical trials has been shown to yield major cost and time savings to the process of clinical research when understood correctly and applied skilfully. Yet even the most modern technological approach to research will fall short of optimal performance if the people using the technology are not fully prepared and the processes to maximise technology’s benefits are inadequate.

This article suggests a fresh look at methodology and performance, encouraging an ‘agile’ approach to clinical trials. Such an approach to conducting trials incorporates the philosophy that:

  • Technology is an important component but it is not the single solution required; as more studies become global in scope the technologies used must be reliable for any given region
  • Workflow and processes that fit the technology are crucial
  • A study team working together – embracing information technology and sharing that information (‘breaking down the SILO approach’) will yield the greatest benefits when employing modern data collection techniques

When all of these components are working together, the result is real-time management, review and integration of clinical trials data into a single co-ordinated database so that sponsors and their research partners can make timely and relevant decisions about the conduct of clinical study or a series of clinical trials.

CONTRASTING AGILE’ WITH ‘ADAPTIVE’ TRIALS

Recently much has been said about the ‘adaptive’ approach to clinical studies. At first glance ‘agile’ can sound like ‘adaptive’, thus it is important to make sure that the distinction is clearly made because the two approaches could not be more dissimilar.

In general, an ‘adaptive’ trial is one in which data is unblinded, revealed and analysed at one or more points in a given study. There is some suggestion that this ‘sneak preview’ approach will enable sponsors to make mid-course corrections to the study design or protocol, perhaps eliminating various non- or mal-performing categories, and as a consequence save time and money that would otherwise be spent ‘playing out the string’. This approach is actually under review by entities such as the US Food and Drug Administration (FDA) in an attempt to find balance between the need for time and costs efficiencies for researchers, and health and safety issues for trial participants and ultimately end-users.


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As President and Founder of Criterium, Inc, John M Hudak has 35 years of progressively responsible research and business development experience in both the corporate pharmaceutical and contract clinical services sectors. He has served as Vice President for New Business Development for Pharmaco (now PPD), Manager of Business Development for GH Besselaar (Covance), and Manager of Clinical Development for Riker Laboratories (a division of 3M Pharmaceuticals). John has led workshops on diverse subjects, such as protocol development, information capture and utilisation, and project management for the Institute for International Research and other organisations, and has led seminars in site selection and real-time data management. John has a Master’s in Business Administration, a Master’s in Biology, and a Bachelor’s degree in Zoology.
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