Wednesday, November 20, 2013

Join the Movement – Time for a Change in Clinical Trials

Today's guest post comes from Veronica Ludensky, Senior Manager, Outsourcing Management, Takeda Pharmaceuticals, Inc. Takeda will be joining Partnerships in Clinical Trials 2014 to chair the track Drug Development of the Future on Tuesday, April 1.  


Change is hard and most of us go to great lengths to avoid it. We create routines in both our personal and professional lives that often prevent us from taking advantage of opportunities for improvement. There’s a reason why we bashfully and sometimes embarrassingly, call ourselves “creatures of habit” and rarely come out of our comfort zone. But when a change comes along that can revolutionize an entire industry, specifically an industry that helps cure disease and heal the unwell, it is selfish for us resist the change.

I’ve been in this industry for 13 years as both a sponsor and clinical research organization (CRO). I’ve seen all parties involved push, pull, and fight against change. The integration of Electronic Data Capture (EDC) took nearly a decade for full, industry-wide acceptance and implementation. Professionals at all levels of a clinical trial were not ready for the change and prolonged the adoption period for as long as they could.

Another area in need of urgent technological change is the collection of imaging data in clinical trials. Clinical trials are getting longer, more complicated and more expensive. Imaging data in trials is more important than ever and is incredibly complex. So given this, why are so many clinical trial sites still sending imaging data on a CD by a courier delivery service that is slow, costly and unreliable? Once the imaging core lab receives the package via snail mail, the data frequently includes errors or omissions and has to be sent back to the clinical site for reimaging or further clarification. This creates the needless query process that can take weeks to resolve. It’s like using an abacus instead of a calculator to solve an arithmetic problem.

One fundamental rule widely accepted within the clinical trial ecosystem is: don’t upset the clinical trial site. But this rule is hindering our ability to pursue opportunities for medical advancement. It’s time for sponsors to have an open and honest conversation with clinical trial sites. With more innovative technology vendors creating opportunities for improvement, it is up to the sponsor to determine which to adapt and champion and which to ignore. We need to come together and implement an industry mandate for workflow enforcement, customized submission tools, automated edit checks and site-side quality control when collecting imaging data for clinical trials.

Including quality control at the site, where the image is captured, will lead to better images acquisition, cost savings and query reduction. The mandate will give sites more control over the trials and make their trials run more efficiently. It would ultimately allow clinical trials to expedite and automate processes along the sponsor-principal investigator-imaging core lab continuum, resulting in more successful outcomes. Now that’s a change I think we can all come out of our comfort zone to support.




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