The clinical trial sector’s overall commitment to improving the patient experience was perhaps the most significant positive change seen over the past year. High dropout rates across all trials – around 30%, according to studies – and 85% of trials failing to enroll enough patients has driven this paradigm shift.
“Improving these numbers is paramount to driving better patient outcomes, and the key is keeping participants engaged throughout the study and removing barriers to participation,” said Wayne Baker, chief commercial officer, Greenphire, a clinical trial payments solution company.
Removing logistical barriers
A survey from the National Institutes of Health cited a “lack of transportation” as one such barrier, particularly among certain participant demographics. As a result, several companies have partnered with ride-sharing companies, such as Uber and Lyft, to remove the logistical burden of organization and paying for transportation.
Moving into 2019, Baker predicts these types of “convenience” services will become a standard offering in clinical research. The industry also will begin to see a shift toward more site-less and/or hybrid trials, he said.
“With the increasing use of technology in health care, participants can communicate with study staff remotely and receive their medications in the mail,” Baker explained, “while mobile health technologies like Fitbit, Apple Watch, Telcare, and others allow participants to transmit real-time data directly to study sites.”
As this trend matures, Baker said sites will look for new ways to engage and retain participants for the duration of a study.
Changing data privacy legislation
Regulations such as the General Data Protection Regulation (GDPR), the California Consumer Privacy Act, the Physician Payments Sunshine Act, and others, “will continue to influence how clinical trial sponsors and sites capture and store participant data, and what they can do with it,” noted Baker.
Ultimately, changing regulations will drive sponsors, sites, and vendors to update and strengthen data system architectures – and will require heightened due diligence to ensure compliance, he said.
“Like to 2018, regulatory changes, and the disparate way that regulations are enforced per state and per country, will continue to be a challenge for sponsors and sites conducting global clinical trials,” Baker added.
“Data privacy will be more scrutinized; therefore, it is crucial to ensure the proper security measures are in place to meet regulatory requirements around the world.”
Pharma companies have been under mounting pressure to increase transparency as it pertains to how funds are dispersed – with some $125-$160bn spent annually on global R&D, according to Greenphire.
Subsequently, Baker said sponsors and sites will prioritize clinical trial payments as a budget item in 2019, “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, benefiting sites and sponsors,” he added.
Using business intelligence
Coming closer to a reality in 2019, is the use of business intelligence to support clinical trial feasibility, Baker said, as the need for better insight into clinical trial data trends – which can support feasibility teams – grows.
“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 have far more accurate business intelligence for enhanced forecasting capabilities that can be used as a baseline for future studies and in support of feasibility,” Baker added.