Leon Barretto

Clinical trial is a research study performed in people that are aimed at evaluating a medical, surgical or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. About 2% of researchers admit to data manipulation, but this figure may be much higher and a new method is being sought to detect flawed data.

it’s the importance of continuously monitoring a trial while it is still going on. In theory, there are two independent bodies that should be doing this: the sponsor-appointed but otherwise independent data and safety monitoring board and the institutional ethics committee that approved the trial in the first place. The ethics committee has the bigger role of the two, especially vis-à-vis protecting the participants’ wellbeing and ensuring the study is conducted ethically.

There were also instances in which investigators had deviated from the approved protocol, putting patients at risk. Every clinical trial has inclusion and exclusion criteria that determine which participants can or can’t be recruited. But the ethics committee found studies in which the study team either hadn’t followed these criteria or had recruited more participants than what had been approved for that site.

The acronym 'ALCOA-C' can be helpful to remember as we think about documentation and record-keeping. Our ALCOA-C checklist, based on ICH GCP E2 Rev2, is a good way to ensure you've covered all your bases, whether you are recording data, making corrections, or writing a report.

It can be made compulsory but it is very tough to actually execute such monitoring. I don’t think it’s acceptable to make something compulsory that can’t be executed. But for-cause monitoring should be compulsory. That is, if you find a reason to monitor, you should monitor.