I think we all agree that patients should have access to their specific study data, but no one is forced to enroll in a study. In fact, the patient is given every opportunity to drop out of the study. You don't even need a reason to withdraw from a study.
In any study, patient data is combined to get an overall evaluation of how effective the treatment is. I do not have a name in the study. I am a series of 6 numbers and letters. By entering the study I gained the possible benefit of the treatment but gave up having access to specific data about myself.
Since my EDSS had gone down, my father wanted copies of my MRIs so that he could have them analyzed for changes. He could not get them. That was a good medical reason, but not a medical emergency. If there were a medical emergency, there probably is a way to recover specific patient data. Knowing your MRTC status is not a medical emergency.
People in the Tysabri study had a true medical emergency. Three people taking Tysabri contracted PML, and two died. About 3,000 patients had taken the drug before it was recalled.
I just reread the 10-page form that I signed to be in the study. There is an experimental subject's bill of rights, but it says nothing about having access to my personal data. My informed consent agreement to be in a research study states "records of you being in this study will be kept confidential except as required by law". It goes on to say with whom the data will be shared, and I am not on the list. I assume if there was a legal reason to see my records, there is a legal process by which I could obtain them. The key issue would be demonstrating that there was a legal reason.
The FDA requires strict adherence to the protocol approved for the study. The company is not allowed to deviate from that protocol without written permission from the FDA. If you are interested in being in this or any other study, you will be given a lengthy consent form to sign. Read it carefully and if you do not agree with all of the conditions, walk away.
Best regards, Tim
In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.