Clinical Study - Oncology

Accelerated FDA approval by 4 months for a major oncology compound in Phase three global clinical trial valued at $1.3M in daily sales.

  • Presenting Project Environment:

    A Global Phase 3 oncology study was running six months behind schedule, jeodardizing approvals for a new compound that was shown to dramatically reduce non-small cell lung cancer tumors. The companies elevated share price reflected the markets confidence in meeting the original submission date announced by its CEO. Yet the new study team lacked certainty in clawing back any of the 6 months projected delay.

  • Work Scope:

    HIP was asked to design an intervention with the Global study team, physicians, site staff and study monitors in order to pro-actively address the delay and produce a turn around.

    Working session were conducted with the study team, data management, Investigators and Monitors to:

    1. Shift the prevailing mindset from the “we inherited a poorly planned study and it is not our fault” to “the future of this trial is in our hands” mentality.
    2. Rapidly develop and increase the leadership being provided up, down and across the study entities
    3. Support the investigators in increasing their reliability for meeting their promised patient recruitment goals on time
    4. Mobilize the data managers to shift their mindset from “pushing data’ to “replacing Chemo as the gold standard”,  and turning around query backlogs with new speed
    5. Cause the required level of relationship between study team members, investigators and site staff to remove barriers and resolve obstacles with speed and creativity
  • Final Project Outcomes:

    The joint breakthrough team produced an on-time database lock and successfully clawed back 4 months from the 6-month approval delay. Sales estimated at $1.3 M per day.