decentralized clinical trials
decentralized clinical trials
Digital technology enables clinical trials that will ease the participation for the patients and ensure that measurements are more detailed. This is an area, where Danish businesses can involve themselves with American research and Silicon Valley’s innovative environment.
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This article was published in Mandag Morgen on March 31, 2022 [in Danish]
Once a week, Gertrude takes a photo of her forearms with her smartphone. She then sends that photo via an app to the doctor, the principal investigator. The doctor is researching and investigating how genetics affect the development of atopic eczema. Gertrude has atopic eczema, and, alongside more than 3,000 patients in Denmark and the US, she is participating in a so-called virtual decentralized clinical trial. Gertrude is a fictional character; the trial however is real and conducted by Bispebjerg Hospital in Copenhagen, Denmark and Stanford Health Care in collaboration with Studies&Me, a virtual contractual research organization.
Everything in the trial is conducted digitally, which makes it easy and less complicated for the patients to participate, as they do not have to go to the hospital for a check-up, which is the case with a traditional clinical trial. Instead, they can participate from their living room via their smartphones. In the beginning of the trial, the participants receive a DNA kit by mail, in which they submit a saliva sample that is brought in for an analysis. Each week the patients submit a photo of their eczema and answer a survey. Furthermore, passive data such as geographical location, daily level of activity and sleep pattern is also collected from the participants. This information is important to the principal investigators when assessing which factors determine the flare up of the eczema.
In Denmark, Europe and especially in the US, clinical research is in rapid development, and an increasing number of clinical trials are digitalized and decentralized. According to GlobalData, it is expected that 1,300 clinical trials with decentral or virtual elements will launch in 2022. That is an increase of 28 percent compared to 2021. This development has been underway for more than a decade, yet it accelerated during the COVID-19 pandemic. Due to the risk of being infected and the enormous pressure on the healthcare system, many of the trials were put on hold in the beginning of the pandemic. They have since been resumed and are conducted digitally and decentralized in the home of the patients.
The participants will typically get the trial medication sent by mail or retrieved by a nurse, who will visit them at home. During the trial, they have ongoing phone or video calls with the principal investigator instead of going for a check-up in person. In addition, wearables or other medical equipment will typically collect electronic data about the patient. The clinic responsible for the trial will then receive the data from the devices digitally. For many patients the decentralized model makes it easier to participate in clinical trials. Mobility and the physical distance to the hospitals are no longer barriers, and at the same time, it lifts the patient’s burden and hassle of going to a hospital for trials.
It is self-evident that not all clinical trials can be conducted in a decentralized manner. The experience in the US is, however, that most of these trials can be, and that even more can be conducted in a hybrid format, where parts of the trial are conducted in the home of the patient, while the rest takes place at the hospital.
The digitalized, decentralized approach to clinical research also gives researchers new possibilities. Dr. Ray Dorsey, researcher in Parkinson’s decease and director for Center for Health + Technology at University of Rochester Medical Center, is a good example hereof. At the Center for Health + Technology, they use sensors, wearables and digital, tele medical technologies to track the patients. With continuous measurements, they can track the symptoms of the patients and their activities from the clinic: Tremor. Changes in motor skills. Number of spoken words. Time spent sedentary. Time spent active. Time spent outside of the home. Time spent alone. Daily number of steps. Pattern of movement within the home. Sleep and sleep patterns. Combined, these digital measurements give Ray Dorsey a far more detailed and continuous picture of the patients in comparison with patients showing up at the clinic for traditional trials. In sum, digitalized and decentralized clinical trials give Dr. Dorsey new possibilities to conduct research in Parkinson’s decease.
The increase in decentralized clinical trials can be measured in the financial markets. According to the market research agency R2G, the European and the North American market for services and technological solutions surrounding decentralized clinical trials will increase from $1.6 B to $8.2 B in 2026.
One of the many startups in the industry is the American tech company Medable, who has their headquarters next to Innovation Centre Denmark in Silicon Valley. In March this year, Medable acquired the Danish app enterprise, Omhu – a spinout of LEO Innovation Lab. Omhu developed diagnostic imaging for dermatology related work, where patients can upload photos using their smartphone, which allows dermatologists to follow the development of the patients. Medable and Omhu are good examples of the emerging ecosystem of service- and technology providers in the space of decentralized clinical trials.
Denmark has great potential to be a frontrunner in the transition to more decentralized and digitalized clinical trials. We have always been a global frontrunner on clinical trials, and we continue to be among the top three worldwide to attract the most clinical trials per citizen. On an international level, we are leaders within digitalization, data security and trust among citizens. On May 4 2021, as the first in the world, the Danish Medicines Agency published guidelines with concrete pointers on how to integrate decentralized elements in clinical trials. In addition, this area is a focus area that is prioritized in the Danish government’s Life Science strategy.
The interest surrounding decentralized clinical trials is big in Denmark. On March 18 2022, 126 participants gathered at a conference organized by The Danish Association of the Pharmaceutical Industry, Innovation Centre Denmark Silicon Valley and Boston, Danish Medicines Agency and Trial Nation. The 126 participants consisted of industry experts, hospitals and authorities, and had the opportunity to gain insights on the experiences with decentralized clinical trials from the U.S., and to discuss how Denmark can implement more decentralized and digital elements in clinical trials.
When looking towards the future, it seems that we will see an increasing number of clinical trials being conducted from the Danish living rooms.
To learn more, check out our report below.
In this outlook we shed light on the American ecosystem within DCTs and highlight important lessons for Danish stakeholders.
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