Q To what extent do companies and regulators need to be transparent about serious adverse events in a clinical trial?
The question of how much information should be made public, at what level and be shared with whom is a contentious one. [Within the clinical trials framework], there is the participant, then there is the study team that knows who the participants are and it is expected to protect their data.
The study team [led by the principal investigator] is overseen by the institutional ethics committee. When a new product is being tested, the company that has made the product becomes the sponsor for the trial. This company cannot ask for identifiable information of the participant; it, usually, will send independent monitors [like a clinical research organisation] that take on the responsibility of maintaining the quality of the study in terms of paperwork, permissions, examining participants’ consent forms, visits etc and the overall performance of the trial site. Even they can have direct contact only with the study team and not the participant.
Institutional ethics committees can monitor at an individual participant level. Then there is the Data Safety Monitoring Board (DSMB) that is also set up to protect participants, and these usually have experts looking at the trial data regularly to recognise problem patterns, which is usually reflected through a cluster of cases. For example, if somebody is administered a vaccine and hits a bug, it is unlikely to be related [to the vaccination]. But if there have been accidents with other participants while they have been in the trial, this would be a signal picked up by DSMB and investigated.
When you do a trial, you are always erring on the side of caution. Anything that sends a participant to the hospital or results in death is going to be treated as a serious adverse event [SAE] and investigated. And then a determination has to be made whether that SAE is related or not.
Now, coming to the issue of what all should be in the public domain and how much information should be shared. Sometimes, people ask for too much information without recognising the uselessness of it. There is always an opportunity cost. You can ask me to make every record identifiable and post it on a public website. That is obviously doable, but how much is it going to cost and how much is it going to delay my group, and its ability to test new interventions? And what value will it add? In the interest of transparency, we can be 100 percent transparent, but that will have very low utility value.
Q A participant taking legal action after having an adverse event during the clinical trial process is unprecedented. Is that a cause for mistrust among the public regarding the vaccination process?
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