After COVID-19 — the new normal in clinical trials
Originally published on LinkedIn by Douglas Bain, Chief Technology Officer at KCR
The Coronavirus pandemic is creating a new ‘normal’ not just during lock-down, but looking towards the future.
Change is difficult to achieve in clinical research. A philosophy of “if it ain’t broke why fix it” combined with a reticence towards assuming risk brought about by change means that the way we do trials today lag behind methods successfully applied in other business areas.
The effects of the pandemic have been to force our hand to some extend in applying methods that were previously seen as not worthy to methods that are a necessity.
So — what do we think will prevail beyond COVID?
Remote monitoring has existed for many years. The actual application of it has had limited impact primarily due to the real need to have CRA / Site interaction for training and engagement purposes. Like it or not, face to face meetings between a CRA and the Site personnel are better when it comes to ‘team’ building and site relationship management.
However, with COVID, and a potential for other similar situations occurring in the future, being able to carry out all functions remotely will be a requirement.
CRO’s operate CRA Monitoring visits through a checklist — CROs and Sponsors need to be looking at being able to perform all of the items typically seen on the checklist — remotely. This includes remote SDV, or a statistically / quality safe equivalent (e.g. Source Data Review), or likely a hybrid.
At KCR, during the COVID lock-down, we are doing the majority of our CRA Monitoring Visits remotely.
CRO Patient Support
We expect a lot from our sites. This has been increasing over recent years with wearables, ePRO etc becoming more regular tools in the clinical trial setting.
We predict that over the coming years, we will see CRO’s — in particular patient facing CRO organisations — pick up a responsibility for patient & site support in a large proportion of trials. This will start in Recruitment and Referrals and continue through long term engagement of the patients. We have seen the need for this during the pandemic with patients unable to visit their sites, and requiring alternative options. We cannot expect sites that have staff not available, or, re-assigned to COVID treatment support to be able to manage clinical trial activities in the same way.
Going forward, we will see CRO patient support services going hand-in-hand with the tech that allows decentralised trial functions with patients — decentralised meaning ‘not at the site’.
Flex Patient site visit support
Building on the above, we (and I include KCR in this) have the technology today to for patients to participate in remote visits either with a single site / concierge service or with the actual site. Again, the need to support this was mandated during the lock-down. It will continue because a). it makes sense to reduce patient burden in certain circumstances and b). we must assume the potential for further COVID like pandemics in the future.
ANY clinical trial that is in planning now should include the above 3 elements as integrated components of their design.
Integrated is key — these should not be a stick-on after thought. This will just make a roll-over to these methods extra work and extra cost that will kill them off over time.
By integrating these methods into our standard solution, we can see efficiencies and improvements that not only mitigate against the risks associated with future pandemics, but deliver better trials in general.