‘We Can be 100 Percent Transparent, But it Will Have Low Utility Value'

Dr Gagandeep Kang, virologist and fellow of the Royal Society of London, on transparency in clinical trials, emergency use authorisation for a Covid-19 vaccine candidate in India and whether it should be available for sale

- DIVYA J SHEKHAR

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.