Case Study 3

Double-Blind Global Study (USA +/India/ Europe in Cancer patients)

SITUATION

This double-blind study required adult patients undergoing moderately to highly emetogenic chemotherapy regimes to establish the efficacy and safety of a single-dose, sustained release formulation of the test article for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). This was one of the largest CINV trials to date. TFS was selected to provide full CRO services including site identification/initiation/training; patient enrolment; project management/monitoring; data management; biostatistics & programming; medical writing, and regulatory consulting.

CHALLENGES

  • Patient enrolment—competition with oncology treatment trials
  • Global Trial - USA, India, Europe
  • Restrictive inclusion/exclusion criteria
  • Complex study design — observer-blind; unique drug delivery system; standardized dosing requirements
  • Investigator site staff turnover throughout multi-year study duration
  • Embedded PK/Holter monitoring sub-study
     

TFS SOLUTION

  • Over 1,400 patients enrolled exceeding client goal
  • TFS assumed responsibility of Hesketh emetogenicity classification scoring — ensured standardization of process, accuracy and consistency by implementing a duplicative scoring system conducted by two certified personnel for every score produced
  • Data base lock 28 calendar days after Last Patient/Last Visit
  • 96,730+ CRFs locked
  • The overall Error Rate for the database was 0.011
     

CLIENT ADVANTAGE

TFS' patient-centric approach addressed the study complexities, met & exceeded study deliverables resulting in an NDA for the customer. The study data was accepted for publication by the American Society of Clinical Oncology (ASCO) and presented at 2009 & 2013 ASCO Annual Meetings with TFS study personnel noted as authors. The drug received FDA approval in August 2016 and a U.S. commercial launch of the drug is planned for the fourth quarter of 2016.