Clinical trial conduct during a pandemic

This pandemic has become a catalyst for global change in all ways of life, not least of which is our approach to clinical trials. Efforts from across the globe have been directed towards identifying vaccines and treatments for the COVID-19 outbreak. While it remains critical that we continue research in other areas, patient recruitment has been halted in many capacities. How can we proceed when your trial is paused? Here are a few tactics to embrace during these times.

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Go virtual

Lockdowns and quarantines have disrupted trials that demand on-site participation. Sure, your patients cannot visit your site but there are ways in which your trial may resume. With the technology available today, your trial could go virtual by embracing the innovations to check in with participants & track how they are coping. Of course, this model is still young and you may be faced with various regulatory obstacles. However, it may be just the opportunity you need to continue your trial as is and reduce your risk of compromising the work you have already completed.  

Recruit for stand-by

You don’t necessarily need to stop recruitment altogether if you find your trial has been paused. During this current crisis, quarantine has ensured that many eligible participants are at home and more importantly, many are on their computers now more than ever. Perhaps you should consider revising your recruitment strategy to focus on producing a registry of eligible participants who can be re-contacted once the trial is re-opened or once the health crisis has passed. Sure, this may demand revisions to materials and creative amendments but once your trial has been given the green light, you can hit the ground running.

Take the time to re-assess

You can use this downtime to reconsider your participant funnel. At a fundamental level, supply chain management begins with directing raw materials to a parts provider, allowing those materials to go through the production process and finally, delivering them to the customer. In patient recruitment for clinical trials, this is no different. The raw materials are the participants who need to be identified, directed to the research sites, and be processed through the clinical trial to ultimately deliver the valuable data to the customer, or rather, the sponsor. What study teams need to understand is whether the lack of enrolment is about obtaining enough raw materials (in this case, identifying potential participants) or accounting for the gaps in the funnel and assessing reasons for screen failure etc.

Depending on the therapeutic area & clinical indication, the conversion ratio could be anywhere between 10 – 30 potential participants required for every successful enrolment. For arguments’ sake, let’s assume the conversion ratio is 12:1. If a site is contracted to randomise 8 participants, they will require access to about 100 potential participants who are diagnosed with the indication in question. However, this conversion ratio can certainly be optimised if the gaps in the funnel can be addressed.

To address these gaps, here are some questions to ask:

• Are you filling the funnel i.e. can you firstly identify enough potential participants?
• How is the current health crisis impacting on participants’ decisions to enrol?
• What messages are you sending out for study awareness and can you fine-tune or optimise these to more accurately depicts the demands and/or benefits of study participation?
• Are you reviewing the tactics of other high-enrolling sites within the study and adopting those strategies within your own site?
• Are you tracking your data? Are you assessing and recording the reasons for screen failure to identify any patterns or recurring causes?

We don’t truly know how clinical trials will evolve due to this pandemic. The industry may witness sweeping changes to protocol designs & healthcare delivery, not to mention willingness to participate & more. All these changes could have significant implications for participant recruitment and retention in clinical trials.