Right at the start of the Covid pandemic last March, my colleague Dan McDonald and I were in Germany at the Munich OECT conference. Like an awkward tingle of electricity, there was an awareness that things might be about to change. But even with sanitizers at hand, we couldn’t possibly have predicted what would come next.
By the time I flew home just three days later, the U.K. was on the cusp of lockdown. Before we knew it, the world ran out of everything from toilet paper to hot tubs, and we weren’t allowed to travel to a supermarket more than a mile from home, let alone attend a conference in another country!
Reality, or at the very least, my reality was paused.
Fast forward 19 months, and there is a push to return to a new normal. Despite everyone’s best efforts, Covid remains a force to be reckoned with. So in the interest of everyone’s safety, conference attendance is virtual, technology is pushed to its limits, and we all share with rapt attention the delights of people’s hard work and presentations whilst wearing our jogging pants neatly hidden under our desks!
Making Trials Patient-Friendly
I attended OECT Munich earlier this month from the depths of my office in rural Gloucestershire, U.K.! I shared a presentation to my peers on how to align seemingly disparate elements of trial delivery – from design, print, and translation, to kitting and logistics, and how this could have a fundamentally beneficial impact on patient engagement.
I prepared my slides, rehearsed my talk, and then spoke of the challenges that patients experience. I told them how we can make the patient’s life easier by taking a little extra time to learn about who they are, the burdens they face, and what matters to them during a study.
And likewise, just as much as we need to listen to the patient and how the trial is delivered to them, we need to understand the burdens, challenges, and constraints involved in all the elements mentioned above.
For example, if translation is delayed, or the translation changes the way a design works, it has a knock on effect to delivery, to production, and in worst case scenarios – to the site initiation visit dates. Communication between these departments or vendors, and collaboration to identify and resolve areas of concern, is paramount to successful delivery.
And let’s face it: now more than ever, our study teams face challenges. Brexit and the global covid pandemic is adversely affecting the supply chain.
Current Struggles for Trials
Another speaker at the conference, Karl-Ludwig Radek, talked about how Janssen has seen the impact firsthand. Challenges in the supply chain, struggles with obtaining key items in lab equipment, and the production and delivery of drugs has actually forced studies to slow down recruitment.
Karl said there are additional hurdles, like challenges in hiring new employees such as CRAs and research staff. This issue actually caused Janssen to reassess their site selection strategy process, using site networks where possible to alleviate much of the concern and the burden involved.
Other speakers addressed additional challenges that they were seeing. Helena Sigal sees challenges with study startup, where unrealistic or short term milestones caused continuous delays and missed timelines. She talked of delayed supplies with technical machinery or medical equipment prompting timelines to get pushed.
Whatever the cause of these delays – individual instances or a cumulative effect across areas — the impact was being felt everywhere. One of the great challenges she reported was site withdrawal due mainly to shifted timelines. These sites had insufficient resources to continually adapt to moving timelines.
Communicating with Patients
Nancy Meyerson Hess did a presentation about patient communication and what is important for clinical trials. She, too, began with talking about sites. She sees sites as being a link – the bridge between patients and pharma. Whereas the above areas indicate that unless supplies reach sites on time, the sites will be burdened, Nancy specifically presented the sites as being a communication tool – to share the wider message to the patient about the study and how best to do so.
She focused on paring back all the unnecessary information and starting with the key study facts to create a baseline of health literacy, which can be expanded as needed. She advised we guide the patient through the study and include them in a respectful way. Ask, listen, and consider their opinions by giving them options wherever possible.
As a patient myself, I would love nothing more than to see the patient become truly engaged in the process around the clinical trial, and not just as an end user and trial participant. But that idealistic approach isn’t always realistic with the hurdles we face and the communication challenges imposed upon pharma from regulators.
Roger Legtenberg gave a talk titled Putting Patients in the Driving Seat to Accelerate Clinical Trials. He spoke of the empty chair, where not all the relevant parties – specifically, the patients – are included in each stage of trial development and provision.
With so many challenges and constraints in the clinical trial industry, it’s remarkable that we still make such tremendous progress and bring about significant numbers of new trials every year.
One speaker, Philippe Auby, shared the details of over 7,000 post-covid mental health studies launched over the last year. On one hand, there is a brutal acknowledgment that Covid and the last 19 months have had a significant impact upon people’s wellbeing. On the flipside, it is incredible that our industry is so resilient.
Clinical trials will continue, no matter what challenges we face. But when over 30 percent of patients still drop out of studies before the end (for many reasons, but life burden is potentially the lion’s share of the reasoning), we need to continually focus on making those studies as easy as possible for everyone involved – the patients, the sites, the teams managing the studies – everyone.
Decentralized trials are certainly here to stay. They take away much of the burden, but as Roger Legtenberg said in his talk, they don’t work for everyone. Just as there isn’t a one-size-fits-all study, the idea of taking the hospital visit burden out of the equation is not a puzzle piece that suits every patient. Some require that human interaction.
Is Something Missing?
Human interaction is what I missed by the end of the conference. It was remarkably well organized and very effective in sharing the points. But I missed the comradery, the shared conversation over a gin and tonic in the evening. Our new normal is nice enough, but I miss the interaction that face-to-face engagement provides.
I think some of the most constructive and striking conversations I have had at conferences are those that have taken place outside of the presentation space.
Trials are a bit like that, too – look outside of the framework for the important details. Talk, and more importantly, listen — and you will find that the message you hear is often very different from the one you thought you would!
How have your trials changed in the last year? What have you learned? Please enter your thoughts in the comment box below.