10 Key Takeaways on the Rise of Decentralized Trials

In our recent webinar, Medrio Founder and CEO, Mike Novotny, and Covance Vice President and Global Head of Hybrid and Virtual Trials, Bola Oyegunwa, shared in-depth insight into the state of the clinical research industry, and how decentralized trials positively impact efficiency, patient centricity, and data quality. This webinar was so popular that we decided to create this blog to serve as a digest, allowing busy researchers to get essential insights quickly. 

 Decentralized trials are gaining steam and serve as a part of a multifaceted solution to some of the biggest obstacles that today’s researchers face. Here are 10 key takeaways:

1. We’re in a golden age of clinical research…

Now is one of the most exciting times to be involved in clinical research. Technological developments, regulatory support, and a dramatic increase in the number of active clinical trials means there are more opportunities than ever to save lives and have a positive impact on global public health:

• Oncology and orphan diseases – two of the fastest-growing research segments – have recently received massive amounts of new funding and have made breakthroughs.
• Clinical trials have gone global. Governments around the world have put regulatory reforms into effect to accelerate research and development. Many have also begun to provide tax incentives. Australia, for example, offers attractive benefits for clinical researchers.

  • 2. …but the industry is stuck in an old-school system

Still, when it comes to patient recruitment and retention – one of the top challenges researchers face – the industry has a long way to go:

•  Most potential participants never learn that clinical trials are an option
•  70% of patients live 2+ hours from a research site
•  In 50% of trials, including oncology, CNS, and rare disease, potential participants are widely dispersed or have       difficulty staying enrolled due to poor health 

Further statistics are underscoring long-standing challenges: 

•  30% of patients drop out – often because they don’t fully understand what they’re getting into
•  40% of trials have difficulties with enrollment
•  85% of trials fail to retain enough patients

3. There are astronomical costs for research inefficiency

Industry-wide, over $100 billion is spent on patients in clinical trials – accounting for 25% of budgets. What’s the average expense to enroll a participant?

•  Phase I: $15,700
•  Phase II: $19,300
•  Phase III: $26,000
•  Phase IV: $26,500

Paired with traditional patient recruitment and retention issues, mounting trial complexity is pushing costs through the roof at an unsustainable rate:

•  The average time to market is still 8 years and costs $2.6 billion
•  80% of trials don’t finish on time, 20% are delayed 6+ months
•  Trial delays can cost between $600 thousand to over $1 million per day
•  Failed trials can cost between $800 million to $1.4 billion

Until now, these challenges have been accepted. But we don’t have to. We have the technology and know-how to improve dramatically.

4. Regulators are actually ahead of the times 

While in many industries regulatory bodies often take time to catch up with industry progress and innovation, this is not the case in clinical research:  

• The FDA, as well as European and Japanese regulators, support new tech in clinical trials
• These bodies have released substantial formal guidance on novel tech use
• Tablets and mobile apps are already commonplace in banks and other highly-regulated industries

  • There are 3 key factors to consider when designing decentralized trials

By harnessing technology already standard in the business and consumer world, decentralized trials give researchers and participants unprecedented geographic freedom. Smartphones and tablets can significantly enhance communication and facilitate remote sharing of health data like blood pressure. eCOA, ePRO, and eConsent further aid high-quality data collection. Successful decentralized trial design should include strategies to:

Reduce participant travel time
•  Less travel can dramatically improve enrollment and retention
•  Even if some patient travel is still needed, easing their burden can go a long way

Boost communication between stakeholders
•  eConsent and televisits keep sites better connected to patients and each other
•  Facilitate direct data flow from eSource to EDC
•  Instant data access ensures everyone can make intelligent decisions in real-time

Improve data quality and improve compliance
• eSource prevents transcription errors and facilitates monitoring
• Ensure proper training so all participants collect data appropriately

5. New technology benefits patient recruitment, retention, and diversity 

Decentralized trials are about getting closer patients – whatever demographic they may be from – and alleviating their burden. Additionally, social media, advocacy groups, and genetic profile companies like 23andMe are gaining steam, increasing the potential to design inclusive trials, and resolve unmet industry needs:

•  Decentralized trials allow people in rural areas to participate more conveniently
•  Direct ongoing engagement keeps patients closely connected throughout trials
•  Participants who feel more valued are less likely to drop out

Test assumptions when designing your trial
Patients have busy lives, and clinical trials are just a component of their larger world. Get patient perspectives and insights on study design because too often researcher assumptions can be wrong:

  • •  A recent survey of patients 65-70 said were open to using mobile apps

•  Patients can help researchers to determine the right technologies to employ

New possibilities and worldwide collaboration
• An organization conducting cholera research in Yemen was able to collect data directly in patients’ home and hospitals, despite limited access to the Internet
• Data synced to EDC when an internet connection was established and that data could be viewed in real-time by teams overseas

6. There are also major benefits for sponsors

The biggest research costs to sponsors are patients. Sponsors must take steps to improve recruitment and retention and reduce overall cycle times. Decentralized trials facilitate this process by helping to:

Reduce patient issues
•  Larger, more diverse participant pools benefit rare disease research
•  Get more informed and engaged patients via tools like eConsent
•  Monitor patients remotely in real-time

7. Get more real-world evidence (RWE) and simplify trials

•  Easily collect RWE in an actual home instead of a doctor’s office
•  Engaged patients fill out eDiaries and ePROs more accurately
•  Eliminate complexity by dealing with fewer sites

Reduce costs and increase speed
•  Enroll patients faster and improve retention
•  Deliver stronger dossiers for regulatory submission

8. Don’t think of decentralized trials generically 

While successful launches and faster recruitment are cited more and more frequently, decentralized trials don’t suit all situations. Still, there are many applications where simple adaptations to a protocol can have an enormous impact. There is usually some low-hanging fruit:

Look at decentralized trials as a component of optimizing study design
•  Examine each aspect of the research process and assess how technology can streamline workflows
•  Be sure to conduct a cost-benefit analysis
•  Don’t let tech drive up the cost of delivery unnecessarily

Even if tech doesn’t reduce trial costs directly, it may still be worth the investment
•  If technology significantly reduces patient burden, it will likely lessen a trial’s overall cost
•  For example, in multiple sclerosis research, reducing site visits can accelerate timelines significantly

9. New tech can help with data quality and regulatory submission

When it comes to compliance and regulatory approval, data quality is top of mind. While paper can be lost and damaged, and patient-reported outcomes can be filled out illegibly or inaccurately, smartphones and tablets have plenty of features to keep data safe and organized:

Accuracy
•  Flag obvious errors immediately on eSource and EDC applications
•  Simplify data history and reporting
•  Ensure patients fill out diaries accurately at the time they claim 

Risk mitigation
•  Make smarter decisions with live, actionable data
•  AI and deep learning tools can provide researchers with key insights and risk predictions 

10. Rapid, widespread adoption is expected soon

  • With regulatory support and in-depth studies showing positive results, accelerated mass adoption is expected soon:
  • •  Decentralized trials can have a massive positive effect on costs and timelines – not just 1-2% 
  • •  Big tech companies like Apple, Amazon, and Google are making large investments in tools that will aid decentralized trials. 
  • •  Stanford and Google have already developed a program that reaches out to participants online for recruitment and sets up participation based on their schedule.