January 31, 2022

3

mins read

Vaccine Trials and Tribulations

It’s September 2020. The Covid pandemic is in full swing, and life sucks. I wanted to do my part, so when I read an article in the BBC about a COVID vaccine trial looking for volunteers, I immediately tried to sign up. The trial in question was for Novavax’s Phase III, looking for 15,000 volunteers across the UK. The trial was well funded with operation Warp Speed money, so I assumed it would be a pretty slick operation. But that’s when things started to get a little strange.


The link in the article to sign up for the trial was: http://www.covid19trial-uk.com/. Go ahead, click the link. You’ll notice the website doesn’t have an SSL certificate, which virtually every website has these days to ensure information remains secure. Google Chrome (reasonably) blocks users from visiting a website without an SSL certificate, as without one basically any 3rd party could access your data. So I had to re-download Internet Explorer (...) to open the site, and entered my contact details, indicating I was interested, feeling slightly sheepish as I’d probably been scammed. 


3 weeks later, I started getting calls from a withheld number. Like most people these days, I ignore these calls, assuming they’re from a vengeful ex or worse a call centre. But then, I remember the clinical trial I signed up for, and sure enough, the call was from a nurse at my local trial site, who wanted to check if I was still interested, and run through some screening questions with me. Eventually, it turns out I am eligible to join the trial, and we book a screening visit at my local hospital a couple weeks later. 


Fast forward to the screening, which takes place in the bowels of King’s College Hospital in a small windowless room with one of the site team. We spent 30 minutes going through what can only be described as a consent ritual, reading a 13 page document written in very legalistic english, that seems designed to make participating in the trial as confusing and unappealing as possible. After providing my ‘informed’ consent, I’m told they can take the initial blood tests and dose me with the vaccine/placebo/microchip straight away. 

Thanks for the microchip Bill!


After my vaxx, I’m taken through other study protocols. Mainly, this involves logging my symptoms once a day in a ‘flu pro-plus’ form on an app called Patient Cloud. Why the app is called ‘flu pro-plus’ and why it is asking me about flu symptoms is a mystery at the time, but I’m given a piece of paper basically telling me to pretend it says ‘covid’ every time it says flu. I spoke to another volunteer on the way out who was frustrated that the app didn’t work on her Android phone, and so she’d been given an iPhone by the study team. Even then, the app didn’t seem to work properly and she’d just resorted to emailing the study team with any “flu” symptoms or vaccine side effects. 

I soon find myself back in the hospital. It's December 2020 and things are… not great covid wise. I’ve been called back in to run some tests - it turns out this just involves me filling out a form asking about my symptoms, and general experiences post vaccine. Why couldn’t this have been done online, surely no-one wants me in a hospital in December 2020? I leave wondering if this was some kind of enforced human challenge trial, as again this visit took place with a bunch of healthcare staff in a windowless, unventilated room (but lots of hand sanitiser!). 


The Novavax trial is extremely well funded, with the trial being overseen by a major CRO. So why does it feel so dysfunctional on the ground? Firstly, on the patient app - this is from Medidata, possibly the market leader in Electronic Data Capture (EDC) for clinical trials. I later learn that it takes them around 3 months to code new questions for a specific trial (ours involved maybe 8 questions), which meant our trial had to repurpose a form that was already live for Flu studies, and they couldn’t get an android version ready in time. I’m not alone in finding the app to be tricky to use


I should be clear at this point - despite the frustrations throughout this piece, all the staff I interacted with were great. Like participants, they also suffer from the industry’s lack of technology adoption and misaligned incentives. The CRO basically outsourced everything patient facing to staff at the trial sites, including recruitment (hence the website…). Trial sites are often (as was mine) in publicly funded hospitals, and the staff are busy with routine care. They’re not really the best organisations when it comes to making participation in a clinical trial appealing to consumers, using technology, and managing recruitment and onboarding of participants. Speaking to several of the team at the site, they complained about having to log everything on paper case report forms, (which meant having participants trek into hospitals), and having to manage participant contact details, and keep track of scheduling and visits on excel. 


So would I volunteer for another trial? Absolutely, and I have. But the experience and frustrations experienced by myself and other patients opened my eyes to the broader problems within clinical trials. Having worked with healthtech and biotech companies for several years, I knew that delays and cost overruns were endemic, with up to 86% of clinical trials delayed by difficulties in participant recruitment. But it took my participating in a trial to see how misaligned incentives and outdated technology and practices led to a terrible participant experience. This in turn leads to more problems for sponsors, as many participants I had learned had dropped out of the study, citing difficulties with the patient app and being asked to come in to fill out forms during Covid. 


I’m also extremely glad I participated in the Novavax Phase 3, because it led to my co-founding Lindus Health in March 2021. We use our end to end clinical trial platform to handle patient identification, recruitment, and every step of the patient journey post enrollment. We’ve already had a big impact, recruiting 6,000 patients to 35 clinical trials and studies, and now conducting entire clinical trials end to end, responsible for all patient interactions from recruitment to study exit (and yes, our patient facing web app has an SSL). We do this because better patient experience leads to better trial outcomes for sponsors, which in turn leads to more effective treatments reaching patients sooner.

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