Six Predictions for 2019

Clinical trial sponsors, sites, CROs, and even participants are asking: what will 2019 bring for clinical trials? Jim Murphy, CEO of Greenphire, shares his predictions on developing industry trends-and how sponsors and sites can avoid roadblocks that can negatively impact their future success. These predictions include:

· The evolution of ‘siteless’ and hybrid trials

While transportation services such as those offered through Lyft and Uber will become a standard offering for site-based clinical trials, we’ll also begin to see a shift towards more site-less and hybrid trials, in which participants will not be required to travel to a clinic for all study milestones, but rather connect with the doctor/site remotely. Healthcare technologies such as Omron HeartGuide, ActiGraph, and Medisafe offer virtual and self-monitoring solutions that can gather data about sleep duration and quality, blood pressure, blood sugar, activity levels, heart rate, and more. With these remote observational opportunities, clinical data can be transmitted to sites electronically while consultation can be done over the phone and medications can be sent via mail. As siteless and hybrid trials become customary, keeping participants engaged throughout the life of a trial may prove to be more challenging. Therefore, sponsors and sites will need to assess and adopt new innovative ways to improve engagement and will be well-served to evaluate digitizing the entire clinical trial experience in order to introduce efficiencies and improve retention.

· The implementation of data privacy legislation 

With recent global regulations being enacted, guidelines and regulatory requirements are becoming increasingly strict, requiring heightened data capture and sharing practices to be implemented. In Europe, GDPR will remain a core focus for sponsors, sites, CROs, vendors, etc., requiring an understanding of differing country-level interpretations. Similarly, in the U.S. we may see more individual states implementing additional data privacy legislation as California has done with the California Consumer Privacy Act (CCPA). New and evolving regulations will ultimately drive strengthened data privacy policies, system architectures and further due diligence to ensure compliance across all healthcare stakeholders.

· Investment in a centralized, global investigator payment solution as a standard will become closer to reality

Every year, billions of dollars are spent conducting clinical trials[1]; yet manual and siloed systems prevent stakeholders from knowing where every cent is going. Sponsors and sites will begin to prioritize clinical trial payments as a budget item with an increased emphasis on improving financial control and overall visibility. By standardizing and centralizing global investigator payments, sponsors can better ensure that clinical trial-related payments are executed consistently, accurately, and in compliance with financial regulations around the world. 

· The use of business intelligence to support feasibility will become standard

There is a growing desire for better insight into clinical trial data trends that can support feasibility teams as they try to predict data flow, timelines, costs, and outcomes. Through the use of technology solutions that aggregate and use data in a smart, dynamic way that can be shared with other interconnected software systems, sponsors will be in a position to make better business decisions. More accurate business intelligence will result in enhanced forecasting capabilities that can be used as a baseline for future studies and in support of feasibility and ultimately smarter clinical trials.

· Making participant travel a priority

One thing we can all agree upon is that getting participants to and from a clinical trial is a basic requirement. However, complexity with regards to therapeutic area, participant age, and trial location can make this a challenging, cumbersome task for the site and participants. A recent survey from the National Institutes of Health notes “lack of transportation” as a key barrier, particularly among certain participant demographics. Even if sites agree to take on travel as part of their study, coordinators are not travel agents and don’t readily have access to systems to arrange the best travel accommodations, especially on a global scale. Nonetheless, quality transportation remains a challenge and impacts retention. In 2019, I predict that more sponsors and sites will integrate travel solutions into existing technology platforms, reducing administrative burdens, and eliminating logistical hurdles to clinical trial participation.

· Technology: Fueling clinical trials of the future 

As the clinical trial industry continues to embrace technology in 2019 and beyond, we expect sponsors put a heightened emphasis on adopting innovative solutions that introduce efficiencies into clinical trials. This effort will target key issues such as increasing participant engagement and retention, reducing administrative work that distracts from research and participant care and enhancing financial transparency for added control. The industry is constantly evolving and innovation is a key factor in driving change. With new ideas and technology, we will see increased efficiency and improved transparency for optimized capital management. This will ultimately enhance the way clinical trials are run, resulting in improved healthcare world-wide.

Jim Murphy, CEO of Greenphire

[1]Igea Hub:

https://www.igeahub.com/2018/08/28/evaluation-of-clinical-trial-costs-and-barriers-to-drug-development/