This past year was a productive one for the clinical trial industry. We saw substantial innovation with technologies that streamline clinical operations and enhance the participant experience. Artificial Intelligence (AI) and patient centricity remained a key industry focus, and real progress was made to shift processes away from siloed and manual efforts into automated workflows.
2020 will continue the momentum towards greater technology adoption and patient focus. Top trends I foresee over the next year include:
1. Global sponsors will embrace and implement patient convenience initiatives to keep participants enrolled and engaged
Patient convenience initiatives will continue to proliferate in 2020 and beyond. There are multiple aspects to this concept of “convenience” and all will remain top priorities for trial sites and sponsors.
- Financial barriers
Financial barriers remain one of the largest reasons cited1for patients being unable to participate in a clinical trial. Sponsors are recognizing that this is a critical issue that needs to be addressed and are actively seeking ways to reduce or even eliminate patient costs.
Patients have been reimbursed for travel expenses for some time, but many sponsors are now taking travel convenience a step further, recognizing that there are often other ancillary costs that can prevent people from participating in a trial. For example, many potential trial participants are parents and must pay for childcare while in the trial-this can be a major financial burden. Or, a patient with a pet may face a hefty pet care bill while traveling for a study and can affect their willingness to participate.
I see the scope of what will be covered as reimbursable expenses expanding in 2020. It’s much more economical for sponsors to identify and address potential roadblocks upfront than to get a patient enrolled, only to have them drop out due to unforeseen costs.
- Logistical barriers-rise of hybrid trials
For some patients, it’s not only the financial burden that prohibits them from participating in a study, but the physical or logistical challenges as well. To address this, some sponsors are turning to a hybrid model, reducing the number of required visits. In a hybrid trial, on-site visits with clinical professionals will still occur, but not as often. Instead, some elements of the protocol and supporting data required will be captured remotely from the participants’ own home. Not only is this more convenient for the patient, but there are benefits to study outcomes as well. Data can be captured in real time on an ongoing basis, and there are fewer costs related to travel. Some sponsors are actually adding micropayments as incentives for these studies to encourage completion of each required portion of the trial. These micropayments have proven effective in increasing compliance, whether that’s completing a diary entry or device utilization (i.e. smart watch) to collect relevant data points.
An increase in meaningful data will enable greater insights for sponsors and ultimately better care for patients.
I want to emphasize that site visits are not going away. There will likely always be a need for human interaction. However, we will continue to see adoption of virtual, remote, decentralized trials in 2020 and beyond, enabled by technologies that connect and communicate.
- Patient-centric trial designs
The industry is moving “patient centricity” upstream and involving patients and patient advocacy groups in the actual trial design process. They are asking critical questions upfront regarding the study and protocol design to ensure that trial design is acceptable to patients and will support recruitment and retention objectives.
2. The site budget and negotiation process will take center stage
Financial lifecycle management in clinical trials is crucial to study success. Over the past decade, site and patient payments have become automated, improving the sponsor and site relationships and streamlining workflows. In 2020, there will be a greater focus on improving study star-up and feasibility with improved data and automation capabilities, specifically related to site budget and negotiation processes.
Setting a trial budget and negotiating with sites has been a long and arduous process that can start the study off negatively, with delays, added costs and frustration. In 2020, we will begin to see new capabilities introduced to “engineer-out” many of the existing challenges and costly processes, ultimately improving the experience for all stakeholders.
3. Electronic data capture (EDC) for patient data will shift towards eSource
Electronic data capture has long been the standard of processing patient data and submitting it to the proper regulatory authorities. eSource satisfies those same requirements but enables healthcare providers to enter data directly into a smart device, eliminating a step and preventing additional opportunities for human error.
To date, there has been some hesitation in implementing eSource systems, driven by complexities regarding device distribution and support. What is the role of the sponsor? Of the Site? Is BYOD (Bring Your Own Device) the better approach? Security and data privacy has also been a concern. However, I believe that we’ve hit a tipping point where many of these objections have been addressed and there has been sufficient adoption and success, paving the way for others to follow suit. The benefits of eSource systems will prove to be favorable, making this a go-to technology approach over the coming years.
Wayne Baker is the Chief Commercial Officer at Greenphire