The COVID-19 pandemic has affected how we run clinical trials, and those Sponsors, CRO’s and Sites that are able to manage trial and patient data securely and digitally are the ones that have been most able to continue their trials with the least interruption. As the curve flattens in many parts of the world and we see restrictions slowly ease, we start to envision a future post Covid-19. Here are my thoughts on what that means for clinical trial management.
Virtualization of (Some) Trials
Virtual trials have been the topic of many a conference headliner in recent years, but prior to the COVID-19 pandemic, there was little mention, let alone guidance from the FDA on how to support virtualization of trials. The recently updated FDA and EC guidelines during the pandemic includes multiple mentions of virtualization in the general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the pandemic.
The FDA and EC guidance has allowed for the rise in remote monitoring and telemedicine as a short-term necessity, but Sponsors and CRO’s are expecting more of their ongoing and future trials to incorporate these monitoring methods and leveraging technology that allows for remote and virtual monitoring. As an example, we’re seeing more trials using wearables to measure respiratory changes or temperature and heart rate changes to indicate early COVID-19 symptoms.
Technology is an Enabler
The studies that have been able to pivot quickly and continue their trials can do so because they had the technology infrastructure.
We’ve been talking about digital transformation of clinical trials for years at SureClinical. After all, that’s our raison d’etre. Without appropriate technology that meets FDA and EC compliance standards, more studies would have no choice but to sideline their studies during COVID-19 because they simply could not support them.
In our COVID-19 webinar series, Nancy Cameron of Clinilabs recently shared that they had been able to convert a 100+ site study to remote monitoring with little more than the need to update work instructions to allow for telemedicine and/or remote visits. Another customer, Novotech, has also been in the news a lot lately sharing their success in continuing trials during the pandemic.
As more trials move to remote or virtual, we see some of the most urgent critical functions needed as:
Secure Portals to Collect Essential Documents
If you’re still sending out hard copy documents, do you even know where to send them to now? Even if printing, scanning and emailing, the process is time-consuming, cumbersome and as one customer tells us, overloads your mail server.
Using a secure portal is easy for almost everyone to use. Many of us have refinanced a home or done our taxes through portals, so there’s almost no learning curve. The best portals are gateways to unified systems, such as SurePortal, so that your documents coming in can be QC’d, tagged and pulled directly into your eTMF. Our customers credit the portal as a key factor in their study startup reduction time.
Digital Signatures
For the same reason we’re not sending out as many FEDEX and UPS packages around for essential documents, remote signatures are a hot topic at the moment, with FDA, EC and the UK MHRA weighing in on compliance requirements. It is important that your eSign solution is both compliant and easy to use. Tip: most commercial solutions don’t meet CFR Part 11 requirements, so caveat emptor. I wrote a blog post dedicated to this topic a few months ago.
Protocol Deviations
The FDA assumes that there will be protocol deviations due to COVID-19 and has asked that they be flagged as due to COVID-19. We can make a reasonable assumption that we will be asked to provide a report of COVID-19 deviations.
Data Insights
Lastly, real-time actionable insights can only come with a 365-degree view of your data. From protocol deviation reporting, to understanding cycle times for all phases of your trials through CTMS, you (or your sponsor) have ever growing needs to measure your data and act upon it quickly.
Digitalization Will Accelerate Treatments and Vaccines to Fight COVID-19
One thing that is clear, we are all in this together. Our mission at SureClinical has always been to speed the development and delivery of life-saving drugs and therapies to patients through our applications. Never has that been more important and we are offering our help. We currently have 4 COVID-19 studies running on SureClinical, and are offering the complimentary use of SureClinical applications to Sponsors, CRO’s and Research Organizations running COVID-19 treatment and vaccine trials. If you are a candidate, simply apply on our website or contact me.
The New Normal
We are forever changed by this pandemic, and for those personally affected, our thoughts are with you. As COVID-19 restrictions slowly ease, we envision a new normal evolving vs. a return to business as usual in a pre-COVID world. Hybrid and virtual trials will become more common, supported by larger investments from Sponsors and CRO’s in the infrastructure to support them.
Patient safety remains paramount, and remote monitoring is seen as a long-term benefit to patients who have risk exposure concerns. For the longer term, we are seeing potential benefits to recruitment of a potential larger reach of subject participants not constrained by the need to check in as frequently to a clinic.
Whether or not FDA and EC guidance supporting remote and virtual trials stays and is enhanced after the pandemic passes is not clear. Generally speaking, it’s hard to unring a bell.
About The Author
Laurie Pattison has spent her career working at the intersection of people and technology. She’s worked in technology long enough to remember Y2K, has spent much of her career focusing on building beautiful, usable products. By day, you can find her responsible for Marketing and Customer Success for SureClinical. On weekends, you’ll find her maintaining social distance hiking with her dogs in the beautiful Sierra Nevada mountains we’re lucky to have in SureClinical’s backyard. Connect with Laurie on LinkedIn.