Wednesday, September 11, 2019 6:28:27 AM
03/11: 50% enrolment
03/19 : Interview in a radio station of Madrid to dr Freire, main investigator of Elche.
I´ve listened again the interview . Here is the transcript , in relation to the duration of the trial.
"¿ Qué duración tiene prevista esta segunda fase?
"El periodo de seguimiento de los pacientes es de 14 semanas y hay 2 semanas previas que se llaman periodo de screening para ver si los pacientes cumplen las características para entrar dentro del estudio y el seguimiento total es de 14 semanas .
Estimamos que EL OBJETIVO ES PARA MAYO APROXIMADAMENTE estén ya reclutados todos los pacientes necesarios para poder llevar a cabo el estudio"
Translation from Google:
How long is this second phase planned?
"The follow-up period of the patients is 14 weeks, there are 2 previous weeks called the screening period to see if the patients meet the necessary characteristics to be in the study and the total follow-up is 14 weeks.
And we believe that the OBJECTIVE IS FOR MAY APPROXIMATELY, all the patients necessary to carry out the study are already recruited. "
05/ 01: Two new centers added in Australia. Another two sites were added later.
05/08: 70% enrolment : 84 patients. 24 patients in two months.
With a low estimation in Au in this period of 10 -15 patients enrolled, we have a total of 94-99 , so it means that Spain has been not able to enroll 21- 26 patients in 4 months...
Considering the enrollment until May and the words of dr Freire it sounds impossible.
He could be wrong for 1 month but wrong in 4-5 months???
IMO. I think that the big delay is due to the extension to Au, in fact could be possible that Spain stopped the trial 2- 3 months ago. The question would be if they stopped the trial with the full enrollment of 120 patients, or they stopped with 90- 100 patients.
It´s the only justification that I see for this big delay.
Saludos!
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