Even before the pandemic, clinical trials were looking for more effective and efficient ways to conduct their work and share information. Since COVID-19’s arrival, finding such solutions is essential.
Robert Giarratani (RG), senior manager at RBW Consulting, recently spoke with Outsourcing-Pharma (OSP) about the unprecedented impact the virus has had on clinical studies, and how advanced solutions like remote monitoring can help trials continue.
OSP: Please tell us a bit about RBW—who you are, what you do, history, and what sets you apart from the competition.
RG: RBW Consulting is a specialist life science and technology executive search consultancy operating in the US, UK and Europe. RBW was founded in 2007 by three experienced professionals who found success in search by combining true industry expertise with an ethical approach.
Andrew Billingham, Nick Rapley and Richard Warren built RBW as a company that always places people before profit. The company's mission is to support people in their careers and encourage innovation in key industries by placing the right people in the right roles, at the right time.
OSP: From your perspective, how has the clinical trial industry evolved in recent years?
RG: There has been a real ramp up in digitalization in recent years but nothing quite like what we saw as a response to COVID-19. Over the past few years, there has been a gradual shift away from traditional paper-based reporting; sponsors, CROs and sites have been making strides to better share information with each other more regularly and that is greatly improved when everyone can work on a centralized, digital platform.
Another change in the industry over the past few years has been in how patient data is treated. At the start of 2017, the US Department of Health and Human Services (HHS) issued a long-anticipated update to clinical trial governance in the United States. This updated regulation gave patients participating in clinical research greater protections over how their personal data is used, stored and secured.
Globally as well, patient data privacy has been a huge focus for the clinical trial industry and something that will continue to be a high priority for sites and CROs as more jurisdictions increase their patient protection legislation.
OSP: How has the pandemic impacted the clinical trial industry—both in the weeks after things first got serious, and in the months since?
RG: The immediate impact of COVID-19 was that a lot of trials sadly had to cease operations. The industry is still feeling the impact of this as some research has slowed but is picking back up again. Meanwhile teams working on a COVID-19 vaccine have been working at speed since early this year.
In the months since the world was gripped by COVID-19, clinical trials have made huge efforts to operate remotely – where possible. This took the form of remote monitoring, digital consent forms, virtual patient consultations and more as site access has remained restricted.
Patient safety has always been the industry’s top priority so by operating more remotely and having fewer people on-site, research centers were able to reopen slowly and safely so patients could continue working with clinical teams on their vital research.
OSP: Can you talk about the ways that trial teams have reacted/adjusted?
RG: I think like most other people, we all had to adjust to suddenly working from home. That has been the most widely felt adjustment, and largely this has been successful.
When COVID-19 initially started to spread around the world, there was an understandable feeling of apprehension around how trials teams could cope if they couldn’t have access to sites or patients. What’s important is that the industry adapted both in terms of keeping their life saving research going and protecting everyone involved in the study.
OSP: What solutions/technologies have been useful in helping clinical researchers to continue their work?
RG: Much like everyone else that has transitioned into a working from home environment, CRAs and clinical teams have implemented some virtual tools to help them monitor their studies. These include Zoom, Cisco Webex and Microsoft teams. I’m sure there are others in use for a range of processes.
It’s important to say that each company is handling this differently, one CRO I work with has a training program in place to get new and current employees up to speed on SOPs, procedures, and how to succeed in a remote setting. By proactively training people on how to work in this new way, they have been able to get back to “normal” more quickly than others.
OSP: Then, please tell us about remote monitoring—how had use of/understanding of the technology evolved in the time leading up to the pandemic?
RG: Remote monitoring isn’t an entirely new concept but before COVID-19, few sites were using it as their primary method of monitoring and auditing trials. However, given remote monitoring’s successes this year, I predict that it will remain a feature for most future clinical trials.
Monitoring is traditionally an incredibly expensive and resource intensive aspect of a trial. CRAs have to travel to sites and remain nearby for days or weeks while they conduct a thorough review of every aspect of how the research is being carried out and recorded.
With remote monitoring, a huge portion of those travel and accommodation costs are removed. And while the time and money savings are clear, this isn’t the top priority for clinical research. Before widespread adoption, there was a concern that remote monitoring would be less accurate than having a CRA visit a site in-person; this concern has been largely abated as virtual monitoring means less data is being entered manually – which often leads to errors, and reviews are tracked and audited much more thoroughly and visibly than before.
Remote monitoring has been such a success story that most of the CRAs that I speak to can’t imagine going back to the processes they were using before the pandemic.
OSP: What adjustments do CRAs and other professionals need to make in an environment increasingly reliant on remote monitoring?
RG: CRAs have largely been very positive about the move to remote monitoring. A lot of CRAs had previously expressed frustrations at how slow and cumbersome their work was before, now a lot of time pressures have been relieved.
Further, CRAs have always had to be diligent, and now they are having to ensure that diligence is transferred to a virtual setting.
OSP: Can you share how RBW has helped clients with that?
RG: I’ve been in touch with many different CROs who wanted to know how the industry was responding to the sudden need for more remote workers. Normally, biotechs have strict onsite requirements, especially with new employees. But more and more started to loosen the requirement of onsite work.
This meant the type of candidate we were putting forward had to be comfortable working independently and adapting to virtual tools as they were being rolled out. It also had the benefit widening the talent pool as we could be more location agnostic and candidates had more options for their job searches.
We flexed our parameters for every client and every candidate to support companies in this significant shift and help CRAs prepare for their new – remote – role.