Blog

Hybrid vs decentralized clinical trials: weighing the options for optimal results

February 2, 2023
Blog

Hybrid vs decentralized clinical trials: weighing the options for optimal results

February 2, 2023

Dennis Velasquez

VP, Commercial, DCT

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Author: Dennis Velasquez | VP, Commercial, DCT

Decentralization, hybrid?

Those approaches in clinical trials are here to help and should be an aid to your activities rather than a burdensome process. I would highly recommend using technologies that are flexible, and flexibility goes hand in hand with the following:

  • Patient centricity
  • Removing the clinician's burden
  • Achieving high levels of patient diversity

If the technology you are using and the team of experts implementing it don’t allow you the flexibility of running either a fully decentralised or a hybrid trial, it is probably not the best solution, furthermore, decentralisation shouldn’t mean that you must spend more money. Allow me to illustrate with an example: iPads for sites, iPads add cost to the sponsors, the burden on the CRO to manage the logistics, and the burden to the investigators that will have another device to enter data in, among others, the platform should allow you to communicate between different devices and achieve the best level of communication between the patients, sponsors, CRO, and investigators so you can collect the best quality data and be 100% aligned with regulations.

While I think the decision to have a decentralised or hybrid trial is determined by a correlation between the therapeutic area and the current technology tools available, to build the perfect decentralized clinical trial, several key elements are needed, the following is what I personally believe are the main 10:

  1. A secure, decentralized platform for data storage and sharing.
  2. A robust system for patient consent and data privacy, to ensure compliance with regulations, such as HIPAA, 21 CFR part 11, 50 etc.
  3. A way to ensure the integrity of the trial data, such as using cryptography.
  4. A way to ensure the quality of the data collected from participants, such as the ability for continuous monitoring and fast actionable mid-study changes.
  5. A way to ensure the comparability of the trial data, such as using a common data model.
  6. A way to ensure the accessibility of the trial data, such as using an SDK (Software Development Kit), an API-based platform or a combination approach.
  7. A way to ensure the scalability of the trial, such as using a cloud-based infrastructure.
  8. A way to ensure that the trial is run in compliance with regulatory requirements, such as using a secure, decentralized platform for trial management.
  9. A way to ensure effective communication and collaboration among all stakeholders.
  10. A way to ensure that the reusability of a questionnaire for example will not involve building from scratch, which turns into added cost and a waste of valuable time

Meet me at #scope2023 to discuss further and find out how we at Huma can solve those challenges.

#clinicaltrials #dct #hybridtrials #ecoa #econsent #telehealth #connecteddevices


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Blog

Hybrid vs decentralized clinical trials: weighing the options for optimal results

February 2, 2023
Blog

Hybrid vs decentralized clinical trials: weighing the options for optimal results

February 2, 2023

Huma joins digital pioneers to advance health equity in care and research

Chief Executive Officer and Founder, Dan Vahdat, is returning to the annual World Economic Forum’s main conference where he will join a panel discussion devoted to improving care for non-communicable disease and tackling health equity. Accompanied by Chief Financial and Strategy Officer, Ingeborg Oie, Dan is looking forward to connecting with other attendees to explore how Huma’s digital health platform can make healthcare more equitable, and advances proactive, predictive care.

Huma joins digital pioneers to advance health equity in care and research

Date:Wednesday, January 18, 2023
Time:4:15 - 5:15 p.m. CET
Location:Ice Village, Eisbahnstrasse 5, Davos, Switzerland
Dan will join the Digital Health Action Alliance panel at Davos to discuss Turning the Tide in Non-Communicable Disease Care Through Digital Health and Community Connection. Huma has a long history of advancing the care of non-communicable diseases (NCDs) such as heart disease, cancer, diabetes and lung conditions. Huma’s innovative remote patient monitoring platform enables broad patient recruitment, reduces reliance on in-person clinic visits and increases health system efficiency.
*This session is open to registered Annual Meeting 2023 participants and Affiliate badge holders.

Huma is one of the first to sign the Zero Health Gaps Pledge

Huma is one of the first signatories to the Zero Health Gaps Pledge, the World Economic Forum’s Global Health Equity Network’s (GHEN) initiative. Huma supports GHEN’s ambition to build a future without disparities in health or wellbeing outcomes. Huma’s digital platform has been built on a deep clinical knowledge of complex patient needs and how people engage with technology and we are committed to ensuring our technology promotes health equity. We are proud to work with governments, hospital groups, universities, life science and technology companies to bring greater scale and impact and help all people live longer, fuller lives.

Huma at World Economic Forum

Global Innovators and Tech Pioneers
Dec 2022: Huma selected to join 100 innovative companies on a two-year journey as part of the World Economic Forum’s initiatives, activities and events, bringing their cutting-edge insight and fresh thinking to critical global discussions.
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Working Together, Restoring Trust
May 2022: With the aim to address economic, environmental, political, and social fault-lines exacerbated by the COVID-19 pandemic, Dan Vahdat speaks at WEF annual meeting about the importance of scientific collaboration.
Learn more
Accelerating innovation and breaking new ground
October 2022: Dan joined the WEF Biotech Future Forum 2022 to discuss how start-ups are breaking new ground in biotech and changing the way we interact with the world, but also how the sector can earn trust, scale successfully and spot the brightest innovations.
Learn more
Making connections at Davos
Jan 2019: Dan attended WEF as an unofficial attendee and spoke to CNBC about the importance of meeting in-person to make connections.
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Blog

Hybrid vs decentralized clinical trials: weighing the options for optimal results

February 2, 2023
Media contact
A headshot of Karen Birmingham PhD
Karen Birmingham PhD
Head of PR & Communications
karen.birmingham@huma.com
Blog

Hybrid vs decentralized clinical trials: weighing the options for optimal results

February 2, 2023
Media contact
A headshot of Karen Birmingham PhD
Karen Birmingham PhD
Head of PR & Communications
karen.birmingham@huma.com

Author: Dennis Velasquez | VP, Commercial, DCT

Decentralization, hybrid?

Those approaches in clinical trials are here to help and should be an aid to your activities rather than a burdensome process. I would highly recommend using technologies that are flexible, and flexibility goes hand in hand with the following:

  • Patient centricity
  • Removing the clinician's burden
  • Achieving high levels of patient diversity

If the technology you are using and the team of experts implementing it don’t allow you the flexibility of running either a fully decentralised or a hybrid trial, it is probably not the best solution, furthermore, decentralisation shouldn’t mean that you must spend more money. Allow me to illustrate with an example: iPads for sites, iPads add cost to the sponsors, the burden on the CRO to manage the logistics, and the burden to the investigators that will have another device to enter data in, among others, the platform should allow you to communicate between different devices and achieve the best level of communication between the patients, sponsors, CRO, and investigators so you can collect the best quality data and be 100% aligned with regulations.

While I think the decision to have a decentralised or hybrid trial is determined by a correlation between the therapeutic area and the current technology tools available, to build the perfect decentralized clinical trial, several key elements are needed, the following is what I personally believe are the main 10:

  1. A secure, decentralized platform for data storage and sharing.
  2. A robust system for patient consent and data privacy, to ensure compliance with regulations, such as HIPAA, 21 CFR part 11, 50 etc.
  3. A way to ensure the integrity of the trial data, such as using cryptography.
  4. A way to ensure the quality of the data collected from participants, such as the ability for continuous monitoring and fast actionable mid-study changes.
  5. A way to ensure the comparability of the trial data, such as using a common data model.
  6. A way to ensure the accessibility of the trial data, such as using an SDK (Software Development Kit), an API-based platform or a combination approach.
  7. A way to ensure the scalability of the trial, such as using a cloud-based infrastructure.
  8. A way to ensure that the trial is run in compliance with regulatory requirements, such as using a secure, decentralized platform for trial management.
  9. A way to ensure effective communication and collaboration among all stakeholders.
  10. A way to ensure that the reusability of a questionnaire for example will not involve building from scratch, which turns into added cost and a waste of valuable time

Meet me at #scope2023 to discuss further and find out how we at Huma can solve those challenges.

#clinicaltrials #dct #hybridtrials #ecoa #econsent #telehealth #connecteddevices


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