How Can Decentralised Trials Foster Patient-centricity: An Insider Look

Nov 18, 2021 | RESOURCES

Interview with Paolo Morelli, CEO of PM Holding & Arithmos, and Michele Montanari, Life Science Applications Manager of Arithmos

The world of Life Sciences has accepted the importance of patient-centricity. However, fully embracing it and adopting patient-centered approaches is not an easy task.

In order to understand where the industry is in this journey and how companies can embrace patient-centricity in R&D in a way that benefits patients the most, we asked two industry experts to answer some key questions on patient-centricity:

  • Paolo Morelli – CEO of PM Holding & Arithmos, who is also involved as a scientific advisor in multiple technology innovation start-ups and contributed to a number of leading industry associations.
  • Michele Montanari – Life Science Applications Manager of Arithmos and expert in Life Sciences technology.

What do you think it means to be patient-centric in the Life Sciences industry in 2021?

Paolo: Companies have been involving patients in the clinical trial design for more than a decade in order to create therapeutics that fit best their needs and expectation.

There are two major aspects in R&D related to patient centricity in 2021:

  • The first one is that we are now able to collect day-to-day data from the patient thanks to the digitally connected medical devices and new potential endpoints. This new approach reflects better the everyday life of the patient.
  • The second aspect is related to the decentralisation (or democratisation) of the clinical trials. Now there is a possibility to enlarge recruitment pool. Life Sciences companies have the possibility to involve patients that live far from the clinical site supported by new technologies that allow to create a real DCT ecosystem. Switch to this approach marks the historical shift from a site investigator-centric approach to a patient-centric approach.

Do you believe technology is the key to speed up the growth of the importance of patients in clinical trials?

Michele: Patients have been always pivotal in clinical trials. However, what was missing or was done poorly, was their active involvement and interaction with the study team.

The technology is changing this. Now patients are in the constant contact with Medical Doctor thanks to instant messaging and video calls. Maybe tomorrow they will have visits and evaluation at home and travel to clinics only for diagnostic.

What I see happening in the not too distant future is the technology permitting to also do diagnostics remotely. We are already getting there – some countries already have equipped vans for diagnostic parked just in from of the patient’s house.

What are the other examples of the technology solutions that Life Sciences companies are already using to foster patient-centricity?

Michele: One of widely used patient-centric solutions is the electronic informed consent. It allows to configure a workflow that fits the study automatising the patient recruitment and screening process with the benefit of integration with EDC platform.

Do you think the pandemic changed the way in which Life Sciences industry approach its R&D processes to centralise the patient role?

Paolo: In times of pandemic, patients avoid or are not allowed to go to hospital and research sites. Companies are using alternatives ways of assessing the patients. They increased the use of technology and remote data acquisition and organised assessment by health professional directly at the patient’s house (for example using nursing services). And it worked out – and this is how we got all our eyes on decentralised trials.

What are the actual advantages of decentralising clinical trials for sponsors?

Paolo: The decentralisation of the clinical trials will allow faster recruitment for clinical trials. Digital Health technologies will also play an important role in enabling trial participants’ experience in modern clinical trials – they will facilitate communication consent and continuous data acquisition and add more context for the remote and in-person clinical interactions.

What are about the advantages of the decentralised trials for patients?

Paolo: Patients will benefit of the so called “democratisation of a clinical trial”, allowing these often life-saving solutions to be available to patients, irrespective of where they live and from the knowledge of local physician on how to connect them to clinical trials. Additionally, collecting high-quality clinical and real-world data through DCTs supports a stronger evidence packages reflecting better the value created for patients.

What are the main challenges in leveraging the decentralised trial model for increasing patient-centricity?

Michele: Ensuring study and regulatory compliance definitely remains one of the biggest challenges in decentralised trials. The remote data collection improves patient study compliance, but increases the risks related to data privacy and Computer System Validation.

Another important challenge is defining smooth dataflows by tracing the data that comes from personal devices like smartphones and integrating it with other technologies used in a clinical trial. Fragmented data is a big headache for study team, and it is also frustrating for patients to retrieve data from different places.

This “new-born” approach, even if quite mature in terms of supporting technologies, is not sufficiently supported by process, best practices and regulatory standards.

Do you have any advice on how companies can build patient-centric R&D processes? 

Paolo: We need to look at the clinical trial processes with the eyes of the patient. Then we need to re-design the old process we have been using for the decades.

Life Sciences companies are started designing innovative roadmap that includes multiple elements such as:

  • process design.
  • Technology assessment.
  • Piloting the innovative solution.

These innovative solutions should always focus on the real value generated for the clinical research and for the patients, as sometimes they are masked as innovative but, in reality, they are just using the new technology in an old context.

Michele: The knowledge of clinical processes, available technology, and system integrations approaches are the fundamental ingredients of a patient-centric study. Nevertheless, Companies should start this amazing journey changing first their mindset: before investing money and time in technologies, they should select the right professionals able to support them in introducing a culture of change and innovation.   

How do you think decentralised trials will change the concept of patient-centricity in the future?

Paolo: I believe that if we are not going back after the pandemic crisis to the old way of performing clinical research, we will see a new era in clinical development. A new era in clinical development with great potential of discovery of novel treatment for the benefit of the patients.

DCTs and the usage of digital solutions represent a supplement to hearing directly from the patient. This allows Life Sciences companies to change their role going beyond the access, adherence, and financial support for medications. They can consider additional factors that impact patient life, such as education, employment and access to healthy food, focusing holistically on the drivers of health.

Interview with Paolo Morelli, CEO of PM Holding & Arithmos, and Michele Montanari, Life Science Applications Manager of Arithmos

The world of Life Sciences has accepted the importance of patient-centricity. However, fully embracing it and adopting patient-centered approaches is not an easy task.

In order to understand where the industry is in this journey and how companies can embrace patient-centricity in R&D in a way that benefits patients the most, we asked two industry experts to answer some key questions on patient-centricity:

  • Paolo Morelli – CEO of PM Holding & Arithmos, who is also involved as a scientific advisor in multiple technology innovation start-ups and contributed to a number of leading industry associations.
  • Michele Montanari – Life Science Applications Manager of Arithmos and expert in Life Sciences technology.

What do you think it means to be patient-centric in the Life Sciences industry in 2021?

Paolo: Companies have been involving patients in the clinical trial design for more than a decade in order to create therapeutics that fit best their needs and expectation.

There are two major aspects in R&D related to patient centricity in 2021:

  • The first one is that we are now able to collect day-to-day data from the patient thanks to the digitally connected medical devices and new potential endpoints. This new approach reflects better the everyday life of the patient.
  • The second aspect is related to the decentralisation (or democratisation) of the clinical trials. Now there is a possibility to enlarge recruitment pool. Life Sciences companies have the possibility to involve patients that live far from the clinical site supported by new technologies that allow to create a real DCT ecosystem. Switch to this approach marks the historical shift from a site investigator-centric approach to a patient-centric approach.

Do you believe technology is the key to speed up the growth of the importance of patients in clinical trials?

Michele: Patients have been always pivotal in clinical trials. However, what was missing or was done poorly, was their active involvement and interaction with the study team.

The technology is changing this. Now patients are in the constant contact with Medical Doctor thanks to instant messaging and video calls. Maybe tomorrow they will have visits and evaluation at home and travel to clinics only for diagnostic.

What I see happening in the not too distant future is the technology permitting to also do diagnostics remotely. We are already getting there – some countries already have equipped vans for diagnostic parked just in from of the patient’s house.

What are the other examples of the technology solutions that Life Sciences companies are already using to foster patient-centricity?

Michele: One of widely used patient-centric solutions is the electronic informed consent. It allows to configure a workflow that fits the study automatising the patient recruitment and screening process with the benefit of integration with EDC platform.

Do you think the pandemic changed the way in which Life Sciences industry approach its R&D processes to centralise the patient role?

Paolo: In times of pandemic, patients avoid or are not allowed to go to hospital and research sites. Companies are using alternatives ways of assessing the patients. They increased the use of technology and remote data acquisition and organised assessment by health professional directly at the patient’s house (for example using nursing services). And it worked out – and this is how we got all our eyes on decentralised trials.

What are the actual advantages of decentralising clinical trials for sponsors?

Paolo: The decentralisation of the clinical trials will allow faster recruitment for clinical trials. Digital Health technologies will also play an important role in enabling trial participants’ experience in modern clinical trials – they will facilitate communication consent and continuous data acquisition and add more context for the remote and in-person clinical interactions.

What are about the advantages of the decentralised trials for patients?

Paolo: Patients will benefit of the so called “democratisation of a clinical trial”, allowing these often life-saving solutions to be available to patients, irrespective of where they live and from the knowledge of local physician on how to connect them to clinical trials. Additionally, collecting high-quality clinical and real-world data through DCTs supports a stronger evidence packages reflecting better the value created for patients.

What are the main challenges in leveraging the decentralised trial model for increasing patient-centricity?

Michele: Ensuring study and regulatory compliance definitely remains one of the biggest challenges in decentralised trials. The remote data collection improves patient study compliance, but increases the risks related to data privacy and Computer System Validation.

Another important challenge is defining smooth dataflows by tracing the data that comes from personal devices like smartphones and integrating it with other technologies used in a clinical trial. Fragmented data is a big headache for study team, and it is also frustrating for patients to retrieve data from different places.

This “new-born” approach, even if quite mature in terms of supporting technologies, is not sufficiently supported by process, best practices and regulatory standards.

Do you have any advice on how companies can build patient-centric R&D processes? 

Paolo: We need to look at the clinical trial processes with the eyes of the patient. Then we need to re-design the old process we have been using for the decades.

Life Sciences companies are started designing innovative roadmap that includes multiple elements such as:

  • process design.
  • Technology assessment.
  • Piloting the innovative solution.

These innovative solutions should always focus on the real value generated for the clinical research and for the patients, as sometimes they are masked as innovative but, in reality, they are just using the new technology in an old context.

Michele: The knowledge of clinical processes, available technology, and system integrations approaches are the fundamental ingredients of a patient-centric study. Nevertheless, Companies should start this amazing journey changing first their mindset: before investing money and time in technologies, they should select the right professionals able to support them in introducing a culture of change and innovation.   

How do you think decentralised trials will change the concept of patient-centricity in the future?

Paolo: I believe that if we are not going back after the pandemic crisis to the old way of performing clinical research, we will see a new era in clinical development. A new era in clinical development with great potential of discovery of novel treatment for the benefit of the patients.

DCTs and the usage of digital solutions represent a supplement to hearing directly from the patient. This allows Life Sciences companies to change their role going beyond the access, adherence, and financial support for medications. They can consider additional factors that impact patient life, such as education, employment and access to healthy food, focusing holistically on the drivers of health.

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