In a time where social distancing has become the norm, the clinical trial industry may be forced to rethink operational aspects. Here’s how LEO Innovation Lab in cooperation with LEO Medical Sciences, Bispebjerg Hospital — Denmark and Stanford — USA have co-developed remote efficacy measures using patients’ own smartphones.
Mette Brøgger-Mikkelsen, Medical Associate, LEO Innovation Lab
Since the COVID-19 crisis became a reality in LEO, we’ve all felt the need to adapt to keep up with our usual workflow in a “business as unusual” situation. For the clinical trial industry, this need is no different as affected sites may not be able to see their trial patients in clinic. Hence, high-quality remote solutions may be essential to prevent miss-out on important outcome and efficacy measures in clinical trials. Luckily, in atopic dermatitis LEO Innovation Lab have for some time now been working on a necessary remedy.
Imagine the potential for clinical trials, if trained doctors were able to assess skin disease severity directly from photos taken by the patients themselves on their own mobile devices. And what if getting a professional dermatologist’s opinion of a skin disease was as easy as posting to Instagram? Current technology to do this in the clinic involves huge and expensive camera setups, but with remote assessment, a novel clinical outcome measure ultimately intended to capture efficacy data in clinical trials, this might just be very close to our 2020 reality.
We need remote assessments in clinical research
Clinical studies predominantly assess the efficacy of treatment in-clinic, where participants frequently need to travel back and forth to be assessed. There’s room for this practice to be turned upside down because aside from making participation inconvenient, this also makes clinical trials burdensome for physicians, as well as resource heavy and slow for the industry. With remote assessments, we can meet patients where they are, using their own mobile phones to report their disease status. Remote visits could serve as an addition to or even replace in-clinic visits and is likely to increase data points during the trail. Photos taken for instance every 2–3 days arguably provide more data points that can enhance our understanding of for instance the onset and overall kinetics of effect of a treatment. When participants can submit photos of their lesions more regularly from the convenience of their homes, they can use their own smartphone to bridge the gap between physical in-clinic visits.
The time is now
Already before the COVID-19 pandemic, clinical trials could suffer from difficulties in recruitment and retention as patients had issues travelling to the clinic. This results in overall delayed trial timelines and expenses exceeding trial budget. Clinical trials’ key objective is to make safe and efficacious medicines available to patients without unnecessary delays and therefore, initiatives to identify and propose remedies for the bottlenecks in drug development is and has been an urgent need for several years (1).
Did COVID-19 make these difficulties even clearer? Absolutely. Novel methodologies to facilitate clinical drug development are needed now more than ever. They should be and already are a major focus in the clinical trial industry as trial participants can no longer just show up at a clinical site. Hence, the entire clinical research value chain from regulators to patients will need to adapt to other ways of assessing clinical outcomes; and given the current situation, they will need to adapt much faster than initially anticipated.
Out of crisis comes opportunity, and COVID-19 could potentially accelerate a much-needed digital transformation in clinical research that was already deemed to happen, but most likely at a much slower pace. Remote assessments utilises patients’ own smartphones and could potentially be incorporated in both classical trial setup introducing digital visits (hybrid) and fully virtual clinical trials (also known as decentralised or siteless trials) where digital technologies are implemented to make trials faster, more convenient, and more flexible.
“Pop-up” clinics are paving the way for remote assessments in dermatology
Any novel outcome measure needs to perform at least as good, as the method it’s trying to replace or support. In LEO Innovation Lab, we’ve tested remote severity assessment of the skin diseases atopic dermatitis and psoriasis in method-comparison studies using high-throughput “pop-up clinics”. Pop-up clinics are one of the recent additions to LEO Innovation Lab’s toolbox and have been used to test how face-to-face consultations and remote severity assessments match up. More than 160 patients with atopic dermatitis and psoriasis have participated in our pop-up clinics. They were all recruited and pre-screened through social media, and guided at the “pop-up clinic” on how to use our proprietary app, that assists the patient in obtaining high quality photos at home, to take and submit photos of their skin, and report their extent of disease. Afterwards, the photos are assessed by our Online Hospital of board-certified dermatologists, and data sets are compared with in-house assessments.
Let’s rethink clinical trial design
These pop-up clinics are essential in combining innovative fail-forward startup designs, with the regulatory and scientific ballast that any new methodology must have. We typically examine 30–40 patients over a few days, when and where it suits the majority of patients. This way, we are flexible and able to adapt each time, and hereby we improve both the patient experience, and the quality of the data that we receive.
“We believe we can use smartphone technology to take photos of skin lesions that are of adequate quality, and report their extent of disease, allowing dermatologists to remotely assess the severity and hence progression of a skin condition over time. Our goal is to implement this technology in clinical studies, assessing safety and effect of novel therapies,” Head of Medical Science & Safety at LEO innovation Lab, Anders Daniel Andersen, says.
We’re ready to advance the future of clinical research
For atopic dermatitis and psoriasis, the results look promising. There’s a good agreement between the disease severity evaluations conducted in-clinic by dermatologists and the remote assessments by blinded dermatologists — and we’re ready to further expand our comparison studies to yield more results in more skin diseases.
As professor Simon Francis Thomsen, Head of Department of Dermatology at Bispebjerg Hospital, says:
“Remote assessment as a novel drug development tool represents a huge potential for clinical research. Atopic dermatitis, psoriasis and other skin diseases are only the initial showcasing of the extensive value remote assessment, both as a disease progression tool and a tool for measuring efficacy endpoints, could bring to patients, the treating physician, and the clinical trial industry overall — a learning I could easily see being adopted into general clinical practice.”
If any good is going to come from COVID-19, one thing will hopefully be a new mindset in the clinical trial industry with fewer barriers for embracing new methodologies in drug development and for accelerating the digital transformation.
Thank you to my colleagues Anders Daniel Andersen, Josephine Wiesener, Theis Bjerre-Christensen and Maria Kunckel for contributing to this post