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The Disruption Series: Maintaining Study Participants from Afar

How clinical trial administrators can retain patients despite isolation measures


This is the third piece in the Lionbridge Disruption Series, a collection of commentary from life sciences experts on how the industry is changing as a result of the COVID-19 crisis.

The ongoing COVID-19 pandemic is impacting virtually every aspect of the business world, with especially tough impacts on the travel and hospitality sectors and small businesses. Meanwhile, the pharma sector faces a sudden increase in demand as the public looks to them for treatments, cures and vaccines. To manage this social responsibility despite the pandemic’s interruption of pharma’s research and development processes, the pharma sector needs to modify its approach to clinical trial execution.

How did clinical trials change in countries “over the hump”?

On March 26, DIA moderated a panel discussion of experts from China who represented the full spectrum of the clinical trial process. Participants shared their findings on the impact that the coronavirus pandemic in China had on clinical trials being conducted there. As one would expect, the disruption to clinical trials was significant. Approximately 70% of ongoing trials were suspended or stalled during the height of the outbreak in China.

Within trials that continued throughout the outbreak, approximately 80% of study participants declined to travel to study sites, even if the government granted them an exception to any quarantine transportation restrictions.

How can the pharma sector prepare for clinical trial disruption?

This major disruption is driving the need for Business Continuity Plans (BCPs) that address clinical trial conduct under a pandemic and include specific action plans down to site and patient level. An essential part of such BCPs is a communication plan to ensure investigators, trial participants, CROs and monitors are clear on any protocol changes being implemented.

With the coronavirus pandemic now affecting over 180 countries around the globe, the potential disruption to the clinical trial process is massive. At the same time, the market need for those medications and treatments is greater than ever before. Sponsors of delayed trials find themselves using multi-channel communications in order to engage patients and hopefully minimize dropout.

What is the role of technology in remote clinical trials?

While the global scale of the pandemic may make it impossible to activate sites in alternate locations in order to avoid suspending a study, the use of tools such as video, telephone outreach, social media marketing, web marketing and newsletters that can keep participants engaged and informed during the pandemic, and thus more likely to re-engage. Patient-facing digital technologies and the use of multi-media channels continue to play an increasingly important role in the execution of clinical trials, and in a crisis such as COVID-19 the value of such technologies become clear.

There are multiple benefits of virtual or hybrid trial designs that utilize technology for remote trial conduct, but a key advantage to using technologies is improved patient recruitment and retention. Technology enables regular patient interaction where patients are otherwise hard to reach.

How can and should sponsors communicate with patients?

The timeline and complexity of clinical trials is a barrier to patient participants in the best of times. With increased stress from the current pandemic, it’s critical that sponsors communicate effectively with participants. This means using plain language in the reader’s first language.

As new trials to fight and prevent COVID-19 start up on an accelerated timeline, regulatory agencies are encouraging international partnerships. To recruit the greatest number of participants, sponsors need to be prepared to translate into language outside their usual audience.

This is where Lionbridge Life Sciences excels. With decades of experience in remote-based translation and interpretation, we can help expand your recruitment pool in any part of the world at any time of day. We offer a speedy on-boarding process, skilled project managers and teams intimately familiar with the life sciences field in a variety of regulatory regions. Reach out and let us help you help the global community.

 

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Mark Aiello
AUTHOR
Mark Aiello