Evolving clinical research tactics amid a global pandemic.

COVID-19 has undoubtedly had a massive effect on everyone’s lives. Whether it’s the shift in day-to-day routines, the cancelations of major events, or the pushing off of future plans, things have certainly changed in the time of coronavirus. And the clinical research industry is no exception.

If nothing else, the general public now has a heightened awareness of clinical research opportunities. But how are these opportunities changing in the wake of a pandemic? We at Praxis have taken a look at a few of the ways clinical trials have changed since COVID-19 – as well as what research might look like in the future.

Telehealth.

During lockdown, many study participants started to worry about how they would travel to their research site. If travel is not allowed, how does a patient in a rare-disease study make it across the country to continue their investigational treatment? With help from the FDA and its comprehensive guide assisting research sites on how to ensure patient safety while maintaining trial integrity, patients can worry less about how to get to their visits and instead focus on meeting study milestones from home.

Telehealth is the practice of delivering healthcare from a distance using technology. Patients may now satisfy requirements for study appointments simply by video calling with their doctor for a virtual visit. Sites are also leaning heavily on e-diaries and mobile apps to track symptoms and adverse events. Even the consent process has changed, with e-signatures becoming more accepted for patient consent forms.

At-home visits.

While some research sites may be operating at a limited capacity, others remain temporarily closed to patients. Sponsors have had to think of some creative solutions to reach their patients and perform study-related procedures all while complying with the protocol. Many sponsors have acted quickly to amend their protocols to allow at-home visits.

With nurses dressed in personal protective equipment (PPE) and armed with all the supplies they would need at an on-site study visit, patients are still able to participate in testing and other procedures required for a clinical trial. From measuring vitals and collecting questionnaires to drawing blood and even administering infusions, sponsors and research site staff are doing everything they can to serve study participants right at home.

Patient communication.

As we work with our sponsors to pivot recruitment and engagement strategies for their trials, one of the topics we address first is patient communication. How are sponsors letting their patients know about the status of the trial, and how do they continue that communication during the ever-changing status of the pandemic? Some sponsors are facilitating regular e-newsletters blasted by the research sites with updates on what participants can expect in the immediate future. Others are engaging with HIPAA-compliant clinical service providers in order to maintain communication and answer questions from patients.

So what comes next? While it may be difficult to imagine life after COVID-19 right now, we do hope that some of the process changes made during this time will be carried over. We can improve clinical research altogether by continuing to offer patients more convenience and more communication.

To learn about how we are supporting our sponsors during COVID-19, contact us today.

Any questions? Want to know more?

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