Case Study: Ophthalmology Recruitment Catch up


Background:

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

Situation/Solution:

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.

Outcome:

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

Contact@ dokumeds.com

Phone: +371 67 553 065

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