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:

• Right time, right priority: We must be cognizant of the fact that there is a need to first tackle issues that are still plaguing pharma (enrollment, retainment, clinical study logistics). These should be a higher priority at this time, and researchers should be empowered to utilize these new tools. 
• Determining what conditions are most ripe for disruption is yet to be realized. Until we identify what current clinical endpoints could be transitioned to digital outputs, it will be hard to answer what therapeutic areas are ripe for digitization.

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.  

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