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Case Study: Ophthalmology Recruitment Catch up


Phase III Open Label study, in Russia. Study results required for Marketing Authorization Application.  10 sites, 120 patients, 12 months recruitment.  Registration study.


Initiation delayed due to regulatory issues with Protocol.  

  • Recruitment period reduced to 9 months. 
  • First Patient In was not in early spring, as planned, but in July – at the peak of annual summer vacations.

October: study is at 35% enrolment to plan, based on original plan. Initiation of initial rescue plan, including newsletter motivation phone calls, additional visits by CRA.

December: Study is at 55% enrolment to plan, after actions.  Now – Seasonal holidays in EU/US start, and then seasonal holidays in Russia – total 4 week significant disruption. 

January: Immediately after Russian seasonal holidays, additional rescue plan was initiated.  Motivation visits by PM in 6 locations across Russia within 10 days.

March: 100% recruitment achieved 5 days ahead of original recruitment deadline, in March. Screening failure rate lower than expected, due to more accurate screening by sites.


Close collaboration with sites, via visits, newsletters, regular contact, and ongoing relationship resulted in rescue of recruitment under difficult circumstances, and reduction in screening failures.

Dokumeds Latvia
Alojas iela 6
Riga, LV-1013, Latvia


Phone: +371 67 553 065

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