Sequoia
Senior member
- Joined
- Sep 19, 2010
- Messages
- 841
- Reason
- PALS
- Diagnosis
- 08/2010
- Country
- US
- State
- Washington
- City
- Seattle
I AM SO ANGRY! i RECEIVED THIS LETTER FROM THE DEX TRIAL COORDINATOR:
Hi Sharon,
Hope all is well with you. I believe the home nurse will be visiting you this Saturday, Sept 22nd for the end of study visit for the Biogen study. Unfortunately this will be your final visit for the study. I know that you were very much interested in participating in the Extension study, wherein you would have received the dexapramipexole study drug, but we cannot enroll you into this new study for 2 reasons.
The first reason is that our IRB (which is the board that is designed to protect the rights and welfare of research subjects) were not in favor of letting our site enroll a subject into an investigational drug study who is no longer able to travel to our site. They discussed your case at great lengths at their last board meeting and the chairman just recently made the decision that we could not enroll you into the extension study.
The second reason is that the sponsor, Biogen, recently indicated that we can no longer obtain the ALSFRS-R QUESTIONNAIRE via email. Since they no longer allow us to complete the questionnaire via email (as we have been doing so), we wouldn’t be able to collect any data from you.
I am SO sorry that you cannot enroll into the Extension study. I know that you were really interested in receiving the study drug. I wish there was a site in Seattle that you could be seen at.
Once you complete your End of Study Visit on Saturday, I will need you to send back the study drug to me. I will send you a FedEx pack and label to return it back to me. Please confirm that you received the End of Study Lab Kit. The nurse will need this to complete the visit.
Best of wishes to you Sharon.
THEY HAVE TAKEN AWAY MY LAST HOPE FOR SLOWING PROGRESSION DOWN!
Hi Sharon,
Hope all is well with you. I believe the home nurse will be visiting you this Saturday, Sept 22nd for the end of study visit for the Biogen study. Unfortunately this will be your final visit for the study. I know that you were very much interested in participating in the Extension study, wherein you would have received the dexapramipexole study drug, but we cannot enroll you into this new study for 2 reasons.
The first reason is that our IRB (which is the board that is designed to protect the rights and welfare of research subjects) were not in favor of letting our site enroll a subject into an investigational drug study who is no longer able to travel to our site. They discussed your case at great lengths at their last board meeting and the chairman just recently made the decision that we could not enroll you into the extension study.
The second reason is that the sponsor, Biogen, recently indicated that we can no longer obtain the ALSFRS-R QUESTIONNAIRE via email. Since they no longer allow us to complete the questionnaire via email (as we have been doing so), we wouldn’t be able to collect any data from you.
I am SO sorry that you cannot enroll into the Extension study. I know that you were really interested in receiving the study drug. I wish there was a site in Seattle that you could be seen at.
Once you complete your End of Study Visit on Saturday, I will need you to send back the study drug to me. I will send you a FedEx pack and label to return it back to me. Please confirm that you received the End of Study Lab Kit. The nurse will need this to complete the visit.
Best of wishes to you Sharon.
THEY HAVE TAKEN AWAY MY LAST HOPE FOR SLOWING PROGRESSION DOWN!