Fast study start up and patient recruitment

HungaroTrial managed the patient enrolment is Bulgaria, Czech Republic, Poland, Romania, Serbia, Slovakia and Ukraine and enrolled 125 patients from the total patient number of 165.

We saved over one year of development time for the US Biotech Client by boosting the enrolment in Central and Eastern Europe.

A US-based biotech company contracted HungaroTrial for a Pneumonia study. Patient enrollment began in the United States, but the team encountered difficulties and turned to us for help.

To assist the Client, HungaroTrial selected case-appropriate and productive sites in Central and Eastern Europe. Subsequently, we were able to enroll the required number of patients in a comparatively short time and completed this infectology project before the planned deadline. HungaroTrial countries enrolled 420 patients within 9 months, which is the 97% of the total patient number.

A US-based biotech started a Phase III. Anal Fissure indication study in the USA, Canada and Israel. Due to slow recruitment from the initial sites, HungaroTrial was contacted to initiate a rescue study.

HungaroTrial quickly moved from agreement to setting up sites in Poland, Ukraine, and Bulgaria and proceeded to enroll the required number of patients in two months.  Due to the hard work of the HT team, the initiation and completion of the study – from the first phone call with the sponsor to unlocking the project database for nearly 100 patients – was completed in only 10 months.

Pompe disease, also called Glycogen storage disease type II, is very rare and one of the most challenging indications. It affects about 1 in 40,000 people in the USA, and about 1 in 100,000 worldwide. There are less than 10 patients registered in Hungary and only 2 patients in the national registry of Bosnia at this moment who will be enrolled into the HungaroTrial’s project. HungaroTrial is managing sites in 7 countries for this ongoing trial: Bosnia, Bulgaria, Hungary, Poland, Romania, Slovakia, and Slovenia.

The entire patient recruitment period was during the COVID-19 pandemic and it had a huge impact on the enrolment and availability of patients, still HungaroTrial managed the enroll rmore than 50% of the total patient number in the whole study (much more than US sites). In Hungary, Serbia, Slovakia and Czech Republic our sites performed extremely well, no delays were recorded during the study, all timelines were respected and all milestones were achieved.The trial site in Hungary, Bethesda Children’s Hospital, Budapest was the worldwide top enroller site in the study, with 18 patients.

HungaroTrial enrolled 12% of the global patient number in less than a month.

This was a typical rescue project situation.  The project was running for 2 years in the USA and Western European countries of which the enrolment was far below the plan. 

HungaroTrial was approached after 2 years from the initiation in the USA and Western European sites, and HungaroTrial enrolled 20 patients in less than a month which was 12 % of 169 global patients for the study in total. 

The global enrolment plan was completed and the study was rescued by the excellent performance of HungaroTrial.