Are You Wasting Money on Unnecessary Protocol Amendments?

Charlotte French, Senior Director and Global Head for Contracting and Outsourcing, EMD Serono

Charlotte French, Senior Director and Global Head for Contracting and Outsourcing, EMD Serono

More than one-third of costly protocol amendments are avoidable, according to research conducted by EMD Serono and Quintiles.

The stakes are high: The average protocol amendment carries a $450,000 price tag, delays a study by 61 days, and hits the clinical trial industry with an average $85 million in opportunity costs, says Charlotte French, senior director and global head for contracting and outsourcing at EMD.

“It’s possible to predict [many] protocol amendments” and avoid those pricey mistakes, French told attendees of ExL Pharma’s Clinical Trials Financial Management Summit on April 7 in Philadelphia, Pa.

Some other interesting stats culled from the EMD/Quintiles research:

  • 60% of all protocols for new drugs are amended; “It’s probably higher,” French says.
  • 20% of those amendments are fueled by design flaws and recruitment challenges
  • 43% percent of amendments occur before the first patient is enrolled
  • 34% of amendments are avoidable

The good news is that, with a proactive and disciplined program, many of those unnecessary amendments can be avoided, French says. She advocates a multi-tier program, including the development of a cross-functional team very early in the process of study design.

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First, bring in the scientific team that leads the study design. Then engage the operational department to discuss the logistics and feasibility of the prospective trial. Finally, include the operations team to assess budgets and contracts. To maximize savings and efficiency, French says it is critical to launch this program before the first real budget is committed to paper. There are any number of benefits.

For example, determine the difference between “nice to have” and “must have” patient assessments, French told attendees. “When teams are challenged, they can often decrease the number,” she says.

Author: Michael Causey