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Transforming Clinical Trials

By Study NeedBy Study Role

April 16, 2020

COVID-19: In This Brave New World It’s Time to Overcome Fear of Clinical Trial Technology

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      Gary Hughes

      Gary Hughes

      CEO & Co-Founder


    It's not an exaggeration to say that the pharma industry must operate at a pace that it’s never seen before to tame or even cure COVID-19.

    As billions of people live in some kind of lockdown, countries, businesses, and society in general cannot endure this kind of restriction indefinitely. And healthcare services – already stretched – cannot continue to operate under this heavy load. While we are resilient in the face of previously unthinkable situations, there needs to be a light at the end of the tunnel.

    Government leaders have a heavy burden to make the right decision of when to loosen or lift restrictions. And so, it is now that the pharma industry must step up to swiftly find a way to help us through COVID-19 and protect us in the future.

    In the “old world” – before COVID-19 – it could take a decade for a new vaccine to come to market. Now, we are all counting on the industry to deliver treatment in months – something unthinkable before the year 2020.

    Traditional clinical trial timetables must be accelerated – safely accelerated – as the world waits for a solution.

    It’s with this speed that clinical trial technology can help pharma to truly transform. And it’s for this reason that Teckro is already supporting five COVID-19 trials with more on the horizon as sponsors race to safely set up COVID-19 trials.

    A stark reality has become evident: namely that clinical trial technology is not a “nice to have” but a “must have.”

    In previous articles I’ve discussed the paper protocol and how both inaccessibility and inconvenience of paper places an unnecessary burden on site staff and physicians. Before, during and after clinical trials, many questions need to be answered, such as which patients are eligible, which trials are suitable, how to manage a toxicity that arises, etc. The current environment creates all sorts of new dilemmas, meaning that it’s more important than ever that those involved use clinical trial technology. Here’s why:

    Rethinking Clinical Trials

    Social distancing isn’t exactly compatible with clinical trials. This is where rethinking how to best conduct the trials comes in. The issue is that there’s a fear of the unknown when it comes to conducting trials from a virtual or decentrialized setting. Data concerns, privacy worries and a very human suspicion of change have all been factors blocking change. Well, it could be that soon there’ll no longer be a choice.

    It may be difficult at first, but ultimately rethinking how clinical trial technology can open the door for greater diversity, with more underrepresented populations taking part. The time of travel to sites meant that those from more remote communities and women (who often have childcare responsibilities as well) haven’t been able to participate as much in the past. If this period of global standstill could be used to test out decentrialized clinical trials, they could well become commonplace in the future. This is good news for society because decentrialized clinical trials means more convenience and more diversity, which will ensure better drug development outcomes.

    Real-time Information

    The clinical trial protocol and other study documents when accessed through binders of paper are generally nowhere near the patient. If there is an adverse event and people are working from home, interaction costs could increase as no one will know how to access the information they need or even who has it! Real time communication can help to streamline discussions between site staff, CRAs and Sponsors, as well as help physicians make quick decisions. In the months ahead, real time communication will not be a luxury but a necessity to guide clinical trial safety and data integrity. In today’s reality, clinical trial technology is the only reasonable means to achieve real-time and yet still compliant communication.

    No Need to Travel!

    The pandemic has made us all rethink our priorities and discover what’s really necessary in the world of work. Some meetings and travel have proved to be superfluous, with videoconferencing doing the job just as well.

    The way clinical trials are structured, there are monitors across multiple sites, with each one potentially having a study coordinator trying to reach the CRA to interpret something in the protocol. The problem is that the CRA could well be travelling to the next site and unable to give the information needed, slowing down the whole communication process and potentially hindering the sites. In turn, Sponsors have limited real-time visibility into the clinical trials especially at the site level.

    By removing this friction, Sponsors can access site-level information to address issues hindering sites. As travel isn’t currently an option for anyone at the moment, it’s a chance to test clinical trial technology that allows staff to communicate in real time.

    Now Is the Time to Overcome Fear of Clinical Trial Technology

    There’s now a globally disrupted workforce and the clinical trial model needs to keep pace with this changing reality. After all, who knows what type of world will emerge in the next few years? The need for transparency, connectivity and mobile access to the protocol anytime, anywhere for all research staff is a necessity. And now, more than ever, the industry must get over the fear of clinical trial technology to adapt to the new reality.