Dr Evan Papanastasiou | MD MSc PhD MBA
The medical monitor is the primary responsible medical officer for the oversight of clinical trials across multiple sites; monitors the quality and consistency of clinical data, prioritises safety issues and communicates effectively with clinical sites and the sponsor.
“Passion provides purpose, but data drives decisions.“
Andy Dunn, American Entrepreneur
Monitoring a clinical trial demands the attention of a vigilant eye in a large volume of data and, at the same time to be able to quickly shift one’s attention to any abnormal finding(s), with potential untoward repercussions. Regular review of adverse events, laboratory and other clinical data is essential, and can be achieved by having access either to individual cases (source data, eCRFs, central laboratory databases and patient profiles) or compiled datasets (tables and listings of coded events prepared by data managers). As clinical data can accumulate at spiraling rates during the progression of a trial, the medical monitor will have to devise effective ways to oversee the overall completion and quality of data gathered, to suggest reasonable reconciliation when needed (i.e. to comply with MedDRA terminology) and to help prepare datasets for regulatory meetings (i.e. IDMC, DSMB).
Handling protocol deviations is among the ‘bread and butter’ of the medical monitor. Having the oversight of multiple clinical sites and a solid knowledge of the clinical protocol, the medical monitor is in position to provide adequate support and advice to sites in order to reduce the impact of these deviations on the safety of study participants and the integrity of data; also should be the first point of contact to suggest and discuss potential modifications in clinical practice, seeking to lower the risk of repeating similar violations in the future.
“One is not exposed to danger, who, even when in safety, is always on their guard.”
Publilius Syrus, Latin Mime Writer
Many untoward events can occur during the course of a clinical trial, and whether or not there is a connection with the treatment provided, they can often compromise the safety and wellbeing of study participants. The characterisation of these events can be cumbersome, even for the most experienced clinical investigator, as the nomenclature used to describe these diverse phenomena is extended (i.e. AE, ADR, SAE, SADR, UDR, SUSAR). However, it is essential that these events are recorded correctly to allow comprehensive reviews to take place (i.e. DSUR or ASUR); thus the contribution of the medical monitor can be crucial in elucidating any dubious cases.
Equally, the medical monitor should assist clinicians in taking all necessary actions to counterbalance the potential noxious effect these events can have on their patients; and even more importantly, to promote safe practices during the course of a clinical trial. The safety and wellbeing of study participants is always paramount and uncompromising for all professional involved in clinical trials.
“The single biggest problem in communication is the illusion that it has taken place.”
George Bernard Shaw, Irish Playwright
Effective communication is undoubtedly a key factor to the success of a clinical trial; however it can often prove a daunting task given the extended number of professionals involved; the medical monitor needs to possess organisational skills to maintain open lines with all involved parties and keep track of the information exchanged during these conversations.
Communication with clinical site and CRO staff (i.e. CRAs, CRCs, PIs, SIs) can be challenging as clinical matters can emerge anytime. One has to respond promptly taking into account the urgency and severity of those issues; maintain a collaborative spirit while adhering to protocol limitations (i.e. in issues related to the inclusion or exclusion of patients); prioritise the safety of participants but also respect the integrity of data (i.e. issues related to the unblinding of treatment); finally, keep a systematic record of all these interactions, to inform future handling of similar situations. Besides, one has to consider the significance of these written communication in future inspections and audits.
Finally, communication with the sponsor, is essential to provide a continual update on the state of the trial; to involve the sponsor in resolving issues of particular importance; and to draw coherent strategies to ensure the smooth running of the trial, in anticipation of various drawbacks and barriers.