Budget Woes Stall Clinical Trials and Stymie Sites

Bio-IT World By Ann Neuer   |  February 21, 2012

Imagine buying a new car or a new house but not knowing the price until the papers have already been drawn up and it’s time to sign on the dotted line.  According to Christine Pierre, President of RxTrials, that’s exactly the situation investigative sites face as they attempt to negotiate budgets and contracts for clinical trials.

“The budget still comes so late in the study start up process for the site.  We’ve been trying to address this for more than two decades, and here it is 25 years later, and we still are being asked to consider studies and go through site selection, the pre-site visit and regulatory process before we have the budget in front of us.  It makes no business sense,” Pierre says.

In addition to its late appearance during study start-up, there are a host of other budgeting and contracting challenges, all of which make this step a notorious bottleneck in clinical trials.  According to a CenterWatch survey, budgeting and contracting remains the top cause of study delay.  Of 950 participating investigative sites, 49% of respondents pegged contract and budget negotiation and approval as a key factor in study delay, more than any other activity, edging out patient recruitment, which scored 41%.  Read Full Article