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Patients are ready to embrace decentralised clinical trials, are you?

Traditional clinical trial designs simply can’t withstand the impact of COVID-19. While before the pandemic, some in clinical research were beginning to adopt virtual components, the move towards designing hybrid decentralised trials was slow. But when it became clear that existing and upcoming clinical trials wouldn’t be able to run as planned, biotech and pharma companies have been scrambling to work out how they can take their trial out of the clinic and into a virtual setting.

The FDA were quick to push hybrid decentralised study adaptations too. In March, they put out recommendations such as phone contact, virtual visits and “additional safety monitoring for those trial participants who may no longer have access to investigational products or the investigational site.” Plus, the Centres for Medicare and Medicaid Services relaxed its reimbursement rates for telemedicine visits.

As clinical research organisations are beginning to adapt, patients are also quickly adopting virtual and digital engagement methods. A Market intelligence firm, IDC, surveyed 1,515 adult patients in the US to learn how COVID-19 has impacted their attitudes towards health tech, and found that:

  • 27% of 18-24 year olds had already downloaded a virtual care app to schedule a remote appointment
  • 13.5% said they accessed a virtual visit or telehealth
  • 46% and 29% accessed telehealth through their healthcare provider and payer, respectively, whereas 7.3% paid for a telehealth visit themselves
  • 83.5% of those virtual visits were first-time visits
  • 80.5% were satisfied with their telehealth experience.

For patients, there are big benefits to giving participants the flexibility to take part in a trial from the convenience of their own home. And flexibility and convenience are marks of a truly patient-centric design. Plus, decentralised clinical trials could attract a more diverse subset of participants as they eliminate so many barriers. For example, the time required and distance they have to travel to the research sites, and the need to take time off work or away from other responsibilities such as caring for others.

Initial key considerations

If you’re looking at how you can adapt an existing or upcoming trial, initial starting points for modifying traditional clinical trial models include the following.

Home visits

A decentralised clinical trial approach allows in-person site visits to be replaced with telemedicine or home health visits. Home health visits can be used to collect samples, administer the study drug, monitor vital signs, or undertake diagnostic procedures.

Electronic patient reported outcomes

Many health screening questionnaires can be answered directly by participants using a validated, self-reported electronic patient reported outcomes (ePROs) as opposed to having a healthcare provider administer the questionnaire. But it’s important to keep in mind that with ePROs, source data validation during monitoring visits is reduced or eliminated altogether, as the ePRO is the new source.

Managing compliance

Phone and text notifications can really help improve compliance in decentralised trials. Setting up automated reminders to participants either directly as a notification from their study app or as an email, can really help streamline communication. Plus, welcome or wellness check calls not only remind participants of their involvement in a study, but also reassure them that their contribution matters, increasing their sense of belonging in the trial, and helping to build a sense of community.

Strengthening communication

In situations where patients and site professionals won’t have as much in-person contact, it’s vital to ensure all other means of communication are as strong as they can be. Patients need to be engaged with regularly and in a way that’s convenient for them, which is where telemedicine efforts such as SMS messaging and chatbot type devices like Alexa, can really motivate them to continue to comply.

Offering patients a choice

While decentralising clinical studies are fast becoming the way forward, that doesn’t mean there isn’t a place for elements of traditional trial models. The trick is to find the right balance of each that suits both your study and your participants’ needs. The ideal scenario would be a study design that can be either all virtual or all physical, or a mix of both, depending on patients’ preferences.

Embracing virtual and digital methods have already begun

There are already some great examples of how organisations have embraced virtual and digital methods:

Fitbit launches COVID-19 wearables study for early detection algorithm

Joining the fight against coronavirus, Fitbit has designed an in-app study with the aim to develop an algorithm for detecting potential COVID-19 cases before the symptoms kick in.

Fitbit hopes that symptom history and long-term vitals data collected at scale could help build an objective profile of COVID-19 cases. Identifying these potential infections early can help encourage individuals to seek care or self-isolate.

2.5 million people in the U.S. and the U.K. have generated valuable data about COVID-19

Scientists who specialise in big data research and epidemiology have developed a COVID Symptom Tracker app designed to collect important information on COVID-19 to help put physicians, scientists and public officials in a stronger position to fight the outbreak.

The COVID Symptom Tracker was launched in the U.K. on March 24th and in the U.S. on March 29th. And it has now been used by more than 3 million people.

The app works by:

  • Collecting daily information from individuals in the community about their wellness, specific symptoms and if they have been tested for COVID-19
  • Providing insights on where the COVID-19 hotspots are
  • Providing information on new symptoms to look out for
  • Offering guidelines around self-isolation
  • Identifying regions in need of additional ventilators and expanded hospital capacity
  • Providing real-time data to prepare for future outbreaks.

The U.K. government has acted upon the app’s estimated infection rates by providing advanced notice to local health authorities about when to expect a surge of cases. Researchers are also using results from the app to investigate risk factors for infection, as well as the effects of COVID-19 on patients' health.

Before you make any drastic trial transformations…

If your organisation hasn’t looked into the type of technologies to develop decentralised clinical trials, it’s worthwhile getting help from those who specialise in this area for adapting an existing, or creating a new study design, as well as managing its delivery and endpoint virtualisation. Take your time to thoroughly research solutions so that you can recognise and understand the challenges of implementing solutions mid-stream, and be aware of the risks that this new approach brings.

Decentralised clinical trials is an absolute must now and for the future. But while it’s important to move with momentum, it’s just as important to ensure patient outcomes are never compromised.

This blog was originally published here.

26th October 2020

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