home > ict > spring 2006 > trials limber up
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.


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.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:

There are no comments in regards to this article.

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.
John M Hudak
Print this page
Send to a friend
Privacy statement
News and Press Releases

3P Biopharmaceuticals receives FDA approval

[Pamplona, September 16th, 2019] 3P Biopharmaceuticals (3P), a leading Contract Development and Manufacturing Organisation (CDMO) specialized in process development and GMP manufacturing of biologics, receives FDA approval after completing the Pre-Approval Inspection (PAI) conducted at the 3P drug substance manufacturing facility.
More info >>

White Papers

High Containment FIBCs Offer a Safe and Cost Effective Alternative to their Rigid Counterparts

ILC Dover

As the need for powder containment and manufacturing in accordance with cGMP standards has grown over the years, companies have sought new alternatives to rigid IBCs. Recently high containment Flexible Intermediate Bulk Containers (FIBCs) have emerged which offer an alternative that provides both powder containment and the benefits of shipping with flexibles.
More info >>

Industry Events

World Vaccine Congress Washington

27-29 September 2020, Walter E Washington Convention Center, Washington, US

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>



©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement