Clinical Trial Industry Predictions

Overall clinical trial operational excellence

The lingering impact of the COVID-19 pandemic has proved that we need to focus on adding new solutions and process improvements to ensure resiliency in clinical trials. However, it’s essential that we don’t think short term. In a new Greenphire survey, sponsors and CROs ranked “enhancing their clinical trial operational effectiveness and speed” as their most important area of strategic improvement for their organization.

To deliver better clinical trials, the industry needs to get better at the business side of medical discovery. Connecting the financial and administrative dots from budgeting through payment execution and the ongoing management of the study can streamline operations, create financial transparency and accelerate overall timelines without sacrificing quality.

More support for sites

Too much tech? Sites are at the heart of any clinical trial and should be highly valued. In order to alleviate some of their burdens, sponsors have been more open than ever to investing in technology, especially as COVID-19 arrived.

These technology solutions can be a great benefit to sites, but they also have the potential to cause more burdens and stress. While technology is the future, in the coming years, as adoption increases, we also will see more consideration for the potential burnout it can bring for sites. We’ll see more technologies be integrated with each other and using single sign on (SSO) capabilities to improve the user experience.

Training time. Previously it was thought that it was “enough” to purchase technology solutions for sites to use. This does not always result in a positive site experience and we will see in 2021 and beyond that more time and support is going to be offered to sites to ensure that they not only know how to start using new tech solutions, but to offer resources to turn to when there are questions and challenges.

Cash is key. Cashflow in trials has always been vital to keep them on track. Now that studies have startup timelines that are half (or even less) of what they’ve previously been, we will see more sponsors supporting sites by ensuring they have enough funds to start and keep things moving smoothly.

Increase in digitization and the regulation that comes with

Sponsors are conducting trials in more countries than ever and all while adopting more and more technology. While this is positive progress, that expansion and technology adoption come with a host of global mandates and regulations which continue to evolve, making things more complex. From tax to data protection, which can vary from country to country, there will be more regulations to consider than ever before. We will see solution providers attempt to offset this by building in flexibility and compatibility into their technologies. 

WFH ---> PFH (participate from home)

COVID-19 took everyone from working in the office to home (if possible). This rang true for those participating in clinical studies as well. While some trials paused, others continued with an updated protocol to enable patient participation from home.

Not only did this pandemic prove that remote participation is a possibility, but that it might actually increase engagement and compliance. Sites and in-patient visits will not go away, but it’s clear that we are going to see an increase in both telemedicine and the use of electronic clinical outcome assessments (eCOA) and electronic patient-reported outcomes (ePRO), as a result.

Trial processes will be evaluated

COVID-19 sparked a race to a virus diagnostic, anti-body test and vaccine. This meant that trials, which in the past would have taken months (or years) to initiate, began in only weeks. While it’s not reasonable to think that these extremely accelerated timelines will stick as-is, processes will continue to be evaluated and improvements will be made. Shortened timelines will not be sustainable without the right technologies in place – so looking into next year, we will continue to see sponsors evaluating how to optimize the “business” side of clinical trials.

Improved access to clinical trials (diversity)

Diversity in clinical trials has been a hot topic recently. The way to diversify the patient pool to get more participation from previously less-represented groups is to improve access for everyone. This means supporting advocacy and awareness campaigns, which we’ve seen the start of, and will continue to see more of into next year. This means using technology to minimize the burdens on patients such as transportation to get to sites, upfront costs to participate such as childcare, time off of work and more. Improving diversity starts with education and will rest on improving access.

Jim Murphy is the CEO of Greenphire