Digital Biomarkers: Impact on future clinical developments and outcomes
|數位生物標記:製藥公司臨床開發的未來 Digital Biomarkers: Impact on future clinical developments and outcomes|
|出版日期: 2020年04月29日||內容資訊: 英文||
Assessing digital biomarker applications that could radically impact pharma's clinical research practice
By precisely and continuously measuring disease symptoms, digital biomarkers can allow pharma to establish valid endpoints for implementation in clinical trials. They are particularly relevant for diseases (such as neurological conditions) where the lack of hard endpoints have hampered product development. They will also have a role in repurposing approved products or shelved chemical entities and will deliver value from designing protocols for refining clinical operations to improving post-marketing surveillance. Where will digital biomarkers deliver real value? Which companies are driving the agenda? What are the challenges of bringing them into mainstream clinical research practice?
New technologies require new thinking and a clear understanding of the future direction this exciting technology could take. That is why in, Digital Biomarkers: Impact on future clinical development and outcomes, we interviewed leading experts to give you a clear perspective of the current thinking, technologies, applications and issues which are shaping this rapidly emerging field.
"Five years from now, I'd be astonished if we ever have a new drug come out that doesn't have some sort of digital companion that goes along with it that would augment the effect of the drug if for no other reason than to just get the medication adherence, or to monitor for side effects. If you just look at the structure of drug companies today, we now have positions for Chief Digital Officers. That never existed 15, 20 years ago, but it's incredibly important because everybody knows that technology is really lagging in the treatment of patients. We need to utilise the awesome technology that's been innovated, and include it in really the biggest health problem we face in the world, which is people living longer and having a lot of symptoms, and not being able to deal with them in a cost effective manner." Joel Sangerman, Click Therapeutics.
"Digital health, digital biomarkers are going to become the norm in healthcare in 10 years. It's inevitable, the question is what shape it takes and who actually wins. There's a pretty high likelihood that a non-healthcare company's going to win this. As you're thinking about your next iteration or your growth strategy I would keep in mind that you're going to be hitting up against digital innovation that's going to happen outside of the current healthcare ecosystem. The winner might be a company that is not considered a big healthcare company today. The things that you need to succeed in this market don't exist in many of today's healthcare companies. If companies are planning for their future, retooling, reskilling, thinking about new approaches and how to get that mind-set into their companies, and to think about the consumer differently. These are all going to be important as they think about their next iteration." Kamal Jethwani, Quantiome .
"I think digital biomarkers are most advantageous for early stage drug development because there, you need to know whether your drug works or doesn't work, so you can do a large phase three trial and confirm the finding. For Parkinson's disease and Alzheimer's disease, we don't know before you go to phase three whether the drug works, and this has led to some high profile, expensive failures that cost thousands of people years of their life and pharma companies millions of dollars. There's also probably room for post-marketing studies to add evidence of efficacy for drugs that are already approved or for product differentiation for marketing purposes." Ray Dorsey, MD, University of Rochester Medical Center.
Digital biomarkers can provide objective, quantifiable, physiological and behavioural data that can be collected and measured by digital devices to explain, influence and/or predict health-related outcomes. Artificial intelligence and machine learning algorithms along with digital technologies will enable researchers to filter datasets to identify appropriate digital biomarkers and monitor response to medication or fluctuations in disease in both clinical and real-world settings.
Each expert has direct experience with digital biomarkers, and has been involved in product development in the pharma sector.
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