We cannot guarantee that the content will display correctly while using Internet Explorer. To have the best browsing experience, please upgrade to Microsoft Edge, Google Chrome or Safari.

December 13, 2019

Clinical Trials are not faster, cheaper or site-less yet [Report Sneak Peek]

Chandana Fitzgerald
&


In January this year, we predicted the top trends in digital health for 2019. We suggested that clinical trials will go virtual and that digital biomarkers will become the norm. However, as we get closer to the end of the year, we can see that this is not a reality yet. How far is it from reality? Has digital made clinical trials cheaper and faster? Has regulation changed to support these ‘new age’ trials? Do we understand what digital signals correspond to clinical end points? These questions have inspired our next HealthXL report on Clinical Trial Optimization. Being completely expert-led, oozing with opinions from the catalysts of this industry, this report looks at 5 key themes to bust the hype and give you the reality with case studies and examples. 

Hype 1: Clinical Trial Recruitment and Retention will dramatically improve with Digital Strategies 

Clinical trial enrollment and retainment are still one of the most pressing issues for pharma. With upwards of 30% drop out rates in clinical trials and delays due to recruitment leading to 80% of clinical trials not finishing on time, there is now hope that digital strategies using social media and data analytics can help ease this process.

The sustainability of current clinical trial enrollment and retainment is not feasible for companies investigating rare diseases with smaller patient populations. Traditional methods of finding patients need to branch out and meet patients where they are currently sharing their own stories peer-to-peer: Online.

Reality: 

There is still little research or documentation to prove that fully engaging in online outreach will dramatically increase patient enrollment into clinical trials or retain patients in clinical trials.



Hype 2: Digital Health Can Lower Costs of Clinical Trials

Drug development has always been expensive and in recent times, we are facing 3 billion-dollar trials. We can only expect drug development to get more expensive. Costs to fulfill regulations, agency expenses, enrollment and retainment are only increasing. Pharma’s burden spans across small molecules, cell and gene therapy. The ability to reduce costs incurred through traditional methods (e.g., clinical research sites, data collection, documentation) and replace them with digital solutions is thus highly appealing. A reduction of site monitoring and site management costs with siteless trials is one example that is seeing much emphasis. A focus on rare diseases and smaller patient populations poses expensive logistical challenges that virtual trials and digital endpoints can solve. 

Reality: 

One could argue that digital tools can make trials more expensive, with the need for additional hardware (e.g., wearables, smartphones), or if used improperly.


Hype 3: Digital Health Can Expand Clinical Endpoints for Clinical Trials

Digital endpoints and biomarkers are gaining traction in clinical research as novel means to demonstrate clinical efficacy of treatment through data that previously were not readily available in significant amounts or practical to collect through traditional research methodologies.

Digital tools such as sensors and wearables also undercut current limitations posed by logistical barriers of patients needing to travel to a research site repeatedly throughout a trial for data collection (e.g., labs, testing, vitals).

Reality:

We are still attempting to understand what digital biomarkers are, and which ones can be captured for various indications, and through what devices. 

Hype 4: Regulatory Frameworks will help us navigate the digital opportunity in clinical trials

Regulation is seen as the panacea that may help us solve how digital really fits into the trials of the future. The FDA, for instance, has been very proactive in terms of working with pharma and startups (as seen from different initiatives) to be engaged in the role of digital health in patient care. As regulatory bodies act to determine implications, pharma will have to abide.

The US is a current leader in showing what digital health requirements will need to be met for clinical trial designs. Other nations that will likely impact design will be China and their utilization of the internet, wearable devices, and associated mobile devices.

Reality: 

Pharma is looking for guidance from regulators and regulators may seem to be expecting pharma to lead the way through R&D and piloting. 


Hype 5: Clinical Trials Across Multiple Therapy Areas are Ripe for Disruption with Digital Health

Much hope has been placed on the utilization of digital health technologies to manage and treat chronic conditions, with easy targets being cardiometabolic conditions due to large populations impacted as well as the surge in devices and apps aimed at this area currently. Pharma is particularly interested in how this could be expanded to include rare conditions, including neurology and oncology, where there is an opportunity to improve quality of life.

Reality:


Where do we go from here? 

We’re excited as an industry about the prospects. However, through the course of collecting perspectives and conducting research for this report, we have realized that there’s far too much hype, too early on how digitization can optimize clinical trials. Keep a lookout for our full report, launching in Jan 2020, where we deep dive into what the (real) future for digital in clinical trials is going to be, corroborated by those laying the foundations in this area. And the next time you see the words ‘Cheaper and faster trials, thanks to digital health’, think of us.  

HealthXL Platform Users can now access a full list of 118 digital health solutions working in clinical trials here>>>
Not a user yet but interested in reading the full report and viewing all associated companies?
Request access here >>>

We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

Request an Introduction

We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

Request an Introduction

Ready to read more? HealthXL members can access the full peak of the report on the HealthXL Community Hub.

Not yet a member of HealthXL? Download your 11 page snapshot of the report.

Download your 11 page snapshot

Connect with peers and share insights

Don't miss out on the discussion of the latest insights and reports on digital health. Meet with peers and take a deep dive for 75 minutes. Unlike at webinars, you can freely exchange experiences and insights to solve challenges and design the future of DTx.

Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Best routes to market for DTx in the EU

18th October @ 10:45AM EDT

Join us as we discuss the best routes to market for DTx in the EU. These 75 minute sessions are guaranteed to be filled with interesting debate and valuable insights, apply now to secure your place.

Featuring
Giuseppe Recchia
Giuseppe Recchia
Co-Founder & CEO, daVinci Digital Therapeutics
Nemanja Kovačev
Nemanja Kovačev
Digital Health Lead, Syrmia
Featuring
Giuseppe Recchia
Giuseppe Recchia
Co-Founder & CEO, daVinci Digital Therapeutics
Nemanja Kovačev
Nemanja Kovačev
Digital Health Lead, Syrmia
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Companion DTx: clinical & economic evidence

20th October @ 10:45AM EDT

Join our Digital Health Meeting focused on Companion DTx: clinical and economic evidence. This informal conversation brings a variety of stakeholders together to discuss and share their thoughts and experiences around this topic.

Featuring
Jordan Silberman, MD, PhD
Jordan Silberman, MD, PhD
Director of Clinical Analytics and Research, Digital Care Delivery, Anthem, Inc.
Céline Ulmann
Céline Ulmann
Head of R&D Digital, Almirall
Featuring
Jordan Silberman, MD, PhD
Jordan Silberman, MD, PhD
Director of Clinical Analytics and Research, Digital Care Delivery, Anthem, Inc.
Céline Ulmann
Céline Ulmann
Head of R&D Digital, Almirall
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

DTx last mile delivery - HCPs and patients adoption

2nd November @ 11:45AM EDT

Join us in this informal conversation where we will discuss the main challenges around HCP and Patient adoption of DTx. Apply now to connect with peers and learn from fellow thought leaders in this space.

Featuring
Shrawan Patel
Shrawan Patel
Founder & MD, Strategy Health
Céline Ulmann
Céline Ulmann
Head of R&D Digital, Almirall
Featuring
Shrawan Patel
Shrawan Patel
Founder & MD, Strategy Health
Céline Ulmann
Céline Ulmann
Head of R&D Digital, Almirall
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Tech Giants, Start-ups or Incumbents, who will disrupt healthcare?

4th November @ 11:30AM EDT

Join our Digital Health Meeting as discuss How do we define disruption in the healthcare industry? What is the ‘extinction event’ healthcare needs and why has it not happened yet? And what are the learnings from Tech Giants’ moves in healthcareApply now to join the conversation and share your thoughts on the topic.

Featuring
Amanda Goltz
Amanda Goltz
Principal, Business Development, Alexa Health & Wellness at Amazon
Conor Hayes
Conor Hayes
Healthcare Lead, Techvie Software
Featuring
Amanda Goltz
Amanda Goltz
Principal, Business Development, Alexa Health & Wellness at Amazon
Conor Hayes
Conor Hayes
Healthcare Lead, Techvie Software

Are you a HealthXL Member? See the Full Report Here

Non-HealthXL Member? You can purchase the report HERE

HealthXL Digital Health Meetings

Want to join the discussion now?

Join our Digital Health Meetings and take a deep dive for 75 minutes into topics like digital therapeutics, patient support, telehealth, clinical trials, dermatology and many more. These Meetings are not regular webinars: No audience, no recording and no hiding behind a screen. You actively participate in a discussion to solve your present challenges and design the future of digital health. And with a free account on our Community Hub, you stay connected and up-to-date on the latest news and insights, allowing you to fully immerse yourself in the topic before, during and after.

Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Best routes to market for DTx in the EU

18th October @ 10:45AM EDT

Join us as we discuss the best routes to market for DTx in the EU. These 75 minute sessions are guaranteed to be filled with interesting debate and valuable insights, apply now to secure your place.

Featuring
Giuseppe Recchia
Giuseppe Recchia
Co-Founder & CEO, daVinci Digital Therapeutics
Nemanja Kovačev
Nemanja Kovačev
Digital Health Lead, Syrmia
Featuring
Giuseppe Recchia
Giuseppe Recchia
Co-Founder & CEO, daVinci Digital Therapeutics
Nemanja Kovačev
Nemanja Kovačev
Digital Health Lead, Syrmia
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Companion DTx: clinical & economic evidence

20th October @ 10:45AM EDT

Join our Digital Health Meeting focused on Companion DTx: clinical and economic evidence. This informal conversation brings a variety of stakeholders together to discuss and share their thoughts and experiences around this topic.

Featuring
Jordan Silberman, MD, PhD
Jordan Silberman, MD, PhD
Director of Clinical Analytics and Research, Digital Care Delivery, Anthem, Inc.
Céline Ulmann
Céline Ulmann
Head of R&D Digital, Almirall
Featuring
Jordan Silberman, MD, PhD
Jordan Silberman, MD, PhD
Director of Clinical Analytics and Research, Digital Care Delivery, Anthem, Inc.
Céline Ulmann
Céline Ulmann
Head of R&D Digital, Almirall
AI in Healthcare
AI in Healthcare
AI in Healthcare
AI in Healthcare

Masterclass: AI-based diagnostics - learnings from a real-world use case

21st October @ 9:00AM GMT

In this masterclass, Zachary Tan (Advisor at CancerAid; Venture Creation Partner at Aegis Ventures; more info here) & Lisa Zhu (Research Fellow of the Center for Eye Research Australia) will walk us through the key learnings from their latest article in Scientific Reports (Nature) on real-world AI-based screening for diabetic retinopathy in Australia. This early-stage study is one of the first globally to describe the real-world implementation of AI in healthcare.

Featuring
Zachary Tan
Zachary Tan
Venture Creation Partner, Aegis Ventures
Lisa Zhu
Lisa Zhu
Research Fellow, CERA
Featuring
Zachary Tan
Zachary Tan
Venture Creation Partner, Aegis Ventures
Lisa Zhu
Lisa Zhu
Research Fellow, CERA
Digital Mental Health & Neurology
Digital Mental Health & Neurology
Digital Mental Health & Neurology
Digital Mental Health & Neurology

Digital Health in Mental Health: Commercialization Models

21st October @ 10:45AM EDT

Join us in this informal conversation where we will discuss the best commercialisation models for digital companies in the mental health space. Our 75 minute sessions are guaranteed to be filled with interesting debate and great conversation.

Featuring
Robert Garber
Robert Garber
Partner, 7Wire Ventures
Sarah Fisher
Sarah Fisher
Senior Director, Global Markets, External Innovation, Johnson & Johnson Medical Devices
Featuring
Robert Garber
Robert Garber
Partner, 7Wire Ventures
Sarah Fisher
Sarah Fisher
Senior Director, Global Markets, External Innovation, Johnson & Johnson Medical Devices

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

We cannot guarantee that the content will display correctly while using Internet Explorer. To have the best browsing experience, please upgrade to Microsoft Edge, Google Chrome or Safari.