Time flies. Two years ago, OpenClinica hosted a webinar, Empowering Clinical Trial Sites to Deliver Better Data, Faster. I had the privilege of collaborating with knowledgeable clinical trial leaders:
- Amanda Bravery, then Head of ICT, Imperial Clinical Trials Unit (ICTU), Imperial College of London
- Maryam Y. Garza, PhD, MPH, MMCi, then Assistant Professor, Department of Biomedical Informatics, The University of Arkansas for Medical Sciences
- Yama Mujadidi, then Clinical Trials IT & Development Lead, Oxford Vaccine Group, University of Oxford
The insights Amanda, Maryam and Yama shared about working with clinical trial sites continue to resonate today.
Common Pain Points for Clinical Research Sites
We started our discussion with the question, What are the most common pain points for your clinical trial sites? Answers ranged from busy, overworked site staff who are trying to see more and more patients, the challenges of getting patients into sites and seeing them in a productive way, and the numerous activities that must happen before patient recruitment can begin, all while trying to “make research easy.” The burdens of data entry, getting the data cleaned in a timely fashion from sites, and increasing rates of burnout among clinical research coordinators also were mentioned.
Garza discussed “two major technology-driven items.”
- Simplifying the eConsent process and figuring out a way for multi-site studies to have a centralized process that individual clinical trial sites can adopt rather than “having to figure out how to do these things on their own.”
- ” The manual, time consuming data collection component, the chart abstraction and the data entry and all of the QC [quality control] that comes along with it.”
Mujadidi mentioned the challenge of learning various technology tools and stressed the desire to streamline technologies that “make things easy for us” to enable the use of the same tools in “different trials through different sponsors.”
Using Technology to Lighten Site Staff Workload
As a follow up, I asked our speakers how technology is reducing the workload on site staff. Garza highlighted the use of EHR-to-EDC integration to streamline the data collection process and the use of the HL7 FHIR standard “to essentially grab that data electronically and pipe it over automatically to the EDC.” She also mentioned the use of mobile health and digital health technologies to improve the workload for site staff.
Mujadidi detailed his organization’s use of technology to prescreen participants, saying,
As you can imagine, as soon as we publicly stated we were running the Oxford AstraZeneca COVID vaccine trial and the media covered it, millions and millions of people come to take part in the trials.” The inclusion and exclusion process meant only for eligible participants did “we collect their personal information, saving a lot of time for us.”
Mujadidi’s organization also used eConsent, real-time, direct data entry, and another technology tool to do real-time data cleaning – and when it became available, deployed OpenClinica Participate™ to digitally collect participant reported outcomes.
OpenClinica Participate™ enables patients to submit their data straight way, which means “the physician and clinical team can easily get access to that data.” This increases safety and helps the trial to understand whether the patient is correctly recording the data.
In the words of Mujadidi, OpenClinica Participate™
saves us a lot of time when it comes to reporting and when it comes to especially some of the submissions, because by that time we had everything actually ready and there was less burden on clinical trial sites. Instead of waiting for months and then suddenly sending thousands of queries, it was doing in real time, meaning they were able to solve those queries as [the study went] along.”
Likewise, the Imperial College of London (ICL) uses OpenClinica Participate™ because
It facilitates some great data collection, and it makes it more accessible working with parents of premature babies. And we can capture the information and also facilitate the capturing of data two years down the line when the children are two years old.” ICL’s Bravery stressed the need to simplify technology solutions as well as ensure staff training and confidence in how to use them, saying, “Technology really does have a place to help reduce the workload, but it’s only as good as the people that are using it and embracing it.”
To learn how OpenClinica migrated Imperial College of London from a legacy system to a modern EDC, which made the above possible, download the case study, Migrating Data Mid-Study – 14 Studies in 16 Months.
To watch the webinar on demand, click here.