Will COVID-19 be the push clinical research needs to be genuinely patient-centric?

Posted by Aidan Gannon on May 6, 2020 10:48:27 AM
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As many of us maintain a mental list of all the things we are going to do differently in the post-COVID world, when we get back to ‘normal’, it can only be hoped that some of the more positive aspects of isolating and social distancing that we’re experiencing now will stand to us in the future. A lot of the changes we’ve made as a community, and as a workforce, have shown the value of how sometimes doing things differently can bring positive outcomes. And, if we reflect on the small successes during this trying time, if we endeavour to actually make real changes within our organisations, communities and governments, it is inherently possible the world will be a better place once we come out the other side of this cruel pandemic and its social-distancing ramifications.

A clear example is how organisations have adapted to the need to implement remote working. Whereas previously there seemed to be an unspoken thought that working from home somehow equated to a day on the couch taking a couple of calls between Netflix shows, the reality, for the most part, is very different. After a few weeks of adjustment, and being on web-meetings where children, spouses and various pets contributed more than the invited participants,  companies are seeing that their people and departments are as efficient as ever. Indeed, we’re finding that when employees do not need to sit in traffic twice a day, and don’t bookend their working day with an often negative and stressful experience, they are happier and more productive. Obviously face-to-face meetings are extremely valuable, effective and necessary, but that need doesn’t mean all employees need to be in the office five days a week. Companies that offer flexibility around working from home will often find a more efficient and effective workforce.

And there are many downstream effects of implementing this change – less travel and parking costs, reduced traffic on the road, reduced air pollution, less stress and the freeing up of office space for much needed urban housing units.

The information and experiences gained from how we are working during this pandemic have obvious lessons for clinical development. Our industry and the over-arching framework of conducting clinical trials needs to change dramatically. With so many people suffering hardship right now, and healthcare workers putting their lives on the line every day, wouldn’t it be ironic if this pandemic serves to be the ultimate push we need to go from talking about patient centricity to actually making it really happen in study design?  

Much repeated statistics in our industry are that less than 5% of patients participate in clinical trials1 and that 50% of sites participating in clinical trials for the first time never sign up for a second2. Frankly, this is a failure and not sustainable.

Patients cite the location of their site as a key driver as to whether they will enrol in a trial3. The time and expense of travelling for visits and the possible need to take time off work and arrange childcare are real concerns for many. With patients unable to travel due to the pandemic and global regulatory authorities publishing guidance around transitioning to enable virtual visits, it is apparent that now is the time to harness technology to design trials around patients and sites. Building studies that facilitate fully and partially ‘virtual trials’, where possible, must be a clear part of sponsors’ strategies. Looking at the range of technologies available – eConsent, eSource, site and patient portals, virtual visits, home nursing and wearables, to name but a few – this is eminently possible in many study types and indications. Analogous to working from home becoming the new normal, the necessity for in-person visits for some trials does not mean all visits in every study need to be face-to-face. Building a hybrid or entirely virtual clinical trial through the technology that already exists needs to be the starting point.

Another barrier to patients signing up for clinical trials is the number of visits and procedures they will face. This is a significant burden for sites too – study coordinators told us4 that patient visits take twice as long as they did 15 years ago. So while commercial interests are obviously crucial to the long-term future of drug development, they cannot override the fundamental need to design studies that will succeed. If the number of visits and assessments has a direct negative impact on recruitment timelines, retention and compliance, then isn’t reducing that burden much more valuable? Not to mention the improved experience of the participants!

So as we adjust to the new world of self-isolating and social-distancing, our industry, above all industries, must take heed of the ‘new normal’ and make that jump into real patient and site centricity.

 

  1. 2017 CISCRP Perception and Insights study
  2. https://www.sciencedirect.com/science/article/pii/S245186541630093X
  3. Structural barriers are the biggest reason for low participation in clinical trials, research shows, JNCI February 19, 2019
  4. https://blog.longboat.com/ten-things-clinical-research-sites-told-us

 


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Topics: Patient Compliance, patient engagement, Clinical Research Conduct, clinical trial technologies, ehealth innovation, GDPR, GDPR Compliance for Clinical Trials, Mobile technology, Clinical Reseach, Clinical Trials, Virtual Clinical Trial, Virtual Trials, Clinical Studies

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