Antibiotic Safety Assessment

Study Description

A Phase IV randomized, unblinded, active-control safety study of Drug X, a fluoroquinolone vs. Drug Y for the treatment of Community Acquired Pneumonia (CAP) and vs. Drug Z in acute bacterial exacerbation of chronic bronchitis (ABECB).

Study Objective

Evaluate and compare the overall safety of Drug X vs. two comparators in patients diagnosed with either of 2 conditions: CAP or ABECB.

Study Specifics

  • Total no. of activated sites: 420
  • Patients randomized: 7522
  • Recruitment Timeline: Aug 2004 – January 2007

Quintiles Services

  • Project Management
  • Project Coordination Center (PCC)
  • IVRS
  • Pharmacovigilance
  • Data Management
  • Biostatistics
  • Clinical Trial Supplies

Key Challenges

A major pharmaceutical company presented Quintiles with a pressing challenge – to collect extensive amounts of Phase IV data in compressed time windows because the treatment conditions were subject to seasonal variants.

  • Rapid startup was imperative: FDA mandated a 3-year deadline for submission of the data.
  • The Sponsor required a strategy that would meet target site recruitment and patient enrollment goals by non-negotiable deadlines – those imposed by seasonal changes.
  • Virtually all sites were research-inexperienced - office-based sites in the general practice community, with no dedicated staff or previous experience in conducting clinical trials.
  • Seasonal peaks and valleys in diagnosed conditions meant efforts had to be targeted to sustain site motivation during slow periods.
  • Contingency strategies had to be in place up front to quickly identify, recruit and replace sites that became inactive.

How Were These Challenges Met?

  • Quintiles used innovative techniques to streamline site initiation, simplify staff training, and foster collaborative relationships to track and retrieve quality data.
  • The role of the Project Coordination Center (PCC) was paramount in producing these results. Site-dedicated professional Research Coordinators provided single point-of-contact support to work with sites and proactively manage every phase of study conduct workflow.
  • The burden of paperwork at initiation was minimized using a one-step process, thereby facilitating rapid activation for inexperienced sites.
  • The PCC worked with sites at start-up to train them quickly, accelerate contracting and proactively develop site specific patient recruitment/retention plans. Web-based study coordinator conferences proved valuable for maintaining site motivation. The PCC ensured investigators met study milestones by maintaining weekly communication with sites to provide structured central monitoring support, track data retrieval, and manage CRF/protocol adherence in a manner consistent with ICH GCP guidelines.
  • Ongoing site recruitment to replace centers using a Quintiles-owned investigator data source saved time and cost.
  • Web-based training modules were employed. Investigators logged in at their own convenience and completed self-paced training. Quintiles could benchmark progress of training in real-time.
  • Two-pronged drug delivery management ensured simple, cost-effective utilization of resources: Study medication was packaged by Sponsor and shipped by Quintiles; commercially available comparator products were provided by a pharmacy voucher system.

Outcome

Patient recruitment targets were met 8 months early, and quality-assured, database lock was achieved 8 months ahead of schedule. The PCC partnered with sites to increase productivity and reduce investigator burden – a win-win for sites and Sponsor. These achievements exemplify Quintiles’ customer centered approach and commitment to turn-key study management service.

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