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Oncology Phase III Rescue Study

Investigational Product: Oncolytic Virus

Therapeutic Area: Oncology

Indication: Squamous Cell Carcinoma of the Head and Neck

Study Phase: III

Sponsor: Biotechnology Company

Study design: Randomized, Double-blind, Multicenter Two-Stage Adaptive Phase III Study

Total number of patients: 167

Sponsor’s goals: Having chosen the first countries (USA, Canada, UK, Belgium), the Sponsor was facing slow recruitment globally and expecting study delays; thus, the Sponsor needed to accelerate dramatically patient enrollment in other regions to meet the marketing objectives.

Our solution: After 16 months of slow recruitment, Sponsor addressed Accell Clinical Research to add an emergency country to rescue the study. In past Russia has proven itself to be one of the top recruiting geographies in oncology. Having completed all formalities and regulatory requirements, Accell had only 6 months for recruitment in Russia.

Case Study Metrics

Patient Recruitment by Accell

 North AmericaWestern EuropeRussia
Enrollment Period (months)26266
Active Sites143210
Patients Enrolled329936
Enrollment Rate (patients/site/month)0.080.10.6

Number of Queries (9 months)

  • North America 47% 47%
  • Western Europe 44% 44%
  • Russia 9% 9%

Enrollment period in Russia was only 23% of the total enrollment period, and Russia had only 27% of sites globally; nevertheless, the enrollment rate in Russia was 6 times higher than in Europe and North America, and Accell recruited 21.6% of total patients in just 6 months.

Accell Clinical Research facilitated greatly the successful and timely outcome of the Sponsor’s phase III study and made it possible for the drug to reach the market within initially planned schedule. A relatively small number of queries and no critical findings in Accell’s region clearly demonstrate a high quality of data received during the trial. Russia has proven itself once again to be a favorable region for fast, efficient, and cost-effective clinical trials conduct that resulted in eventual Sponsor’s success.

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