Hope my email finds you in great health. I'm raising this issue because we are now confronted with this urgent problem and I really need your help in resolving it.
We are currently conducting a phase IV double-blinded study that randomizes hypertensive research subjects into two arms : one receives the innovator drug and the other receives a generic one. The problem that arises is that some subjects were controlled on the study medication ( which is unknown to the blinded team and to the participant ). Thaoe subjects are now off study because they completed the duration of the reseach but they have to know the nature of the drug they were receiving in order to contiue on it.
The PI consulted me regarding this issue and I advised her to continue providing the subjects with their medication till the end of the study when we can break the blindness and hence prescribe the appropriate drug for each participant. She asked me to provide her with a document or a guideline that supports my openion in order to include it in her report to the sponsor ( this project is sponsored by Alexandria University and as we all know the budget is limited and it doesn't cover this exta cost) , so she is going to ask for extra money to buy the drug.
Please, help me by your openions and thoughts and I'll be grateful if you can provide me with a guideline that can support me in this issue so that we can avoid exploitation of our research subjects and at the same maintain the scientific integrity of the study.
Dear colleagues and friends,, Â Â Â Â Â Â Â Hope my email finds you in great health. I'm raising this issue because we are now confronted with this urgent...
Dear Nadia: thank you for asking an interesting question. Some points of clarification: how long are the participants on the study drug? What drug were...
Dear Dr. Nahed, Thanks a lot for your kind help, but as I mentioned in my previous email to Dr. Henry that both drugs are now considered standard of...
Dear Nadia: thanks for the extra information. Sounds like an important study, but I have some more questions: 1. is it clear in the informed consent that...
Dear Nadia, Thank you for raising this important issue , in my opinion ,if it is already mentioned in the informed consent that they will receive the drug for...
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Dear Nahed: I would not use the word 'deviation', as this word should be reserved for actions that do not follow the protocol in a bad way. Having said this,...
Dear Nadia& all I will just try to analyze the situation Nadia described& I appreciate getting Dr Henry's feed back. As I understand this will be described as...
I appreciate Samia's statistical approach to the study being described. But, I think Nadia's dilemma's is in regard to what to do for the participants who are...
Dear Nadia and all What I understood that both drugs proved to be equivalent and you r asking about stopping for one arm of the study ,and this is mentioned in...
Dear ALL, Â Â Â Â Â Â Â I'm glad that your are all trying to help us. To clarify I'm not the PI or even a subPI, but I'm a member of the management team of...
Dear Nadia I am Happy to hear that you r Glad from the help offered by our kind group, this is what expected from all of us and from the creation of this...
Dear all Allow me to submit my opinion according to having some experience in the field of research in international environment. I believe what should be...
Dear Jimmy Thank you for your participation in the discussion by your valuable opinion ...Thank you also for introducing your birthday ( No gifts dear...
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