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Leaner, simpler approach to clinical research needed

Monday, February 15, 2016

One month after we’ve started our New Year’s resolutions, how many are sticking?

As I write this in early January, I’m at the definition stage, and sim­plifying life is No. 1. Clinical re­search would benefit from the same resolution of simplification. How will we ever modernize clinical re­search so the results of those years of study tell us whether the product works and is safe, but the process is radically streamlined so it’s a sus­tainable enterprise in the future?

It seems that we have over-engi­neered the clinical research busi­ness until it’s almost like the U.S. tax code—with all its added cost, complexity and bureaucracy. Small­ish phase II studies that should de­termine go/no-go decisions have copious objectives, dozens of ven­dors with multiple plans that docu­ment details, and teams standing by creating memos to file that explain what wasn’t done and why. After the wheels come off, we have large vendor reset meetings to remind ev­eryone who’s doing and overseeing. And for what?

If we could make a comprehensive effort to let risk-based monitoring be the cornerstone of a leaner, more sim­plified approach to clinical research, it would solve three challenges that threaten the status quo: vendor costs that are approaching a breakpoint, especially for early-stage programs in small companies; turnover of moni­tors, resulting in associated quality issues; and reluctance by physicians to continue as clinical investigators because of the administrative burdens associated with industry studies.

There have been considerable ef­forts by companies like Medidata and CluePoints to create dashboards to facilitate the process, and early results are encouraging when data-quality dashboards that guide cen­tralized decision-making eventually will be the air traffic controls that are needed. A comprehensive effort by CROs to share best practices should be next so that the entire system can be overhauled to yield timely and cost-effective results.

 

Written by Guest Writer Laurie Halloran. Halloran is president, CEO and founder of Halloran Consulting Group, a management consulting firm for life science companies.

This article was reprinted from Volume 23, Issue 02, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.comSubscribe >>

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