Clinical trials of novel treatments are governed by a tight legal framework, putting in place many elements of participant surveillance to record and address adverse events, aiming to identify potential side-effects of the treatment under investigation. Lawmakers have strengthened these protections over the decades, and many clinical trials now have formalised external reporting arrangements that monitor reporting from multiple sites of investigation. These arrangements also give a sense of reassurance to researchers, lifting some responsibility off local shoulders.
However, by themselves, they cannot address one of the fundamental issues of good trial leadership: putting in place accessible and responsive support for trial participants when unplanned events occur. This is particularly important for incidental findings that result from a trial’s investigations. Going through these scenarios before a trial begins is a manifestation of good clinical trial governance.
Defining a chain of escalation in case of adverse events helps support participants and the research team alike: This chain of escalation needs to consider both participant queries and incidental findings of trial-specific investigations, and often includes professionals from neighbouring disciplines to cover the gamut of all trial investigations. With that support in place, a healthcare professional taking a participant call can be confident to advise on simple remedies like over-the-counter pain medication, but also has access to timely senior input when dealing with more complicated issues such as infection, or an incidental finding. Communicating such findings to trial participants can generate significant anxiety, for example where imaging of the brain has discovered an abnormality. Putting plans in place before informing participants greatly reduces participant anxiety. Specialist review will often put the relevance of incidental findings into perspective, and where appropriate, a Consultant appointment can be put in place. This way, participants will not be left alone with information they are often poorly equipped to process unsupported.
In summary, “planning for the unplanned” helps retain the trust of trial participants, and also supports the clinical research team in giving them confidence to deal with unexpected events. Lastly, and importantly, A&E visits and GP calls can be minimised where good advance planning avoids scrambling for participant support at short notice.