When we began this journey we held a webinar from October 2020, Let’s Disrupt eClinical Trials: How Optum is Changing the Industry, and it highlighted new tools and programs that Optum is using to improve patient recruitment. In this second in series where we are sharing our learnings, we surveyed our audience with the same questions to see how our users needs may have changed from when we began this journey until now. And, what a difference a year makes in terms of attendees using EHR/EMR/RWD!

In our latest webinar, Adaptive Clinical Systems’ and Optum’s leadership from the Digital Research Network showcase how Optum is modernizing eClinical Trials. Digitally enabled clinical trials are needed to facilitate faster enrollment and simplify data management to reduce the burden on research staff. Sponsors and CROs need to recruit patients more efficiently, and research sites need better tools to find patients that qualify for trials and simplify data entry for studies. Optum is changing how sponsors and sites work together to streamline the recruitment and data management process.  During this webinar Optum’s leadership discusses the processes they have implemented to reduce prescreening efforts and simplify electronic data transfer from eSources to EDC which resulted in clean data and very satisfied research staff.

Other highlights from the observational study include comments on extraction and loading of RWD:

67% of respondents indicated that the process of extracting data directly from the EHR and loading it to the EDC saved them >50% effort of which half indicated it saved them >75%

83% respondents indicated high or extremely high level of confidence in the accuracy and completeness of the EHR data collected during the study

100% of respondents indicated moderate to extremely high level of certainty in using a similar data collection and management procedure for an interventional trial in the future

We looked at pain points in clinical trials. We discussed process and data with the FDA, and they suggested that we do a study to prove out that these technologies work and make an impact on sites including eligibility and time. – Peter Payne

We also believe that the optimal configuration is a heterogenous environment. – Sina Adibi

We wanted to pre-define the data fields that we were interested in collecting, and then, assessing if those data fields were available in the EHR. – Peter Payne

It is unique that we had diverse data sources, and we needed a solution that was flexible. – Peter Payne

It is unique that we had eConsent eligibility confirmation coming in from one source, ePRO coming in from someplace else, and three different EHR systems streaming in… Being able to consolidate all of this data and load it into the EDC with Adaptive Clinical every night was so much easier for the sites. Rather them worrying about entering the data into the EDC the next day. – Cynthia Senerchia

Your team was great to work with. You were very flexible. This was new and a little different in terms of defining data. – Peter Payne

Although the EDC ends with de-identified data, the starting point for us is PHI. There is a huge amount of sensitivity about PHI, and that data remains protected. – Peter Payne

We polled our sites and got good feedback. We were happy and felt confident we picked the right fields and the right data. My goal in life is to have people not have to enter data more than once. That is what we proved in this study. – Cynthia Senerchia

Data collection and the query process was very easy and streamlined. In a normal study those tasks take a lot of time and effort. If I were to estimate that time saved, I would say it’s 80% reduction in what we would usually do. Very simple. Very quick. Very efficient. Very timely.  —Site 300, Study Coordinator

The ability to have patients essentially pre-selected for the study was so attractive for us. Not having to do significant data queries or a lot of manual chart evaluation significantly shortened the pre-screening process. —Site 100, PI

We saw source data verification; data transcription was eliminated. We saw that this was eliminated 100 percent in the study. If we reduce it 50 percent, we are way ahead of the game. – Sina Adibi

To access the replay of the most recent webinar, Using Electronic Health Records & Time-saving Technologies to Modernize Clinical Trials. click here: https://adaptive-clinical.com/learning-more-ehr/

To learn more about changing patient recruitment strategies for hybrid and digital trials, see the webinar Let’s Disrupt eClinical Trials: How Optum is Changing the Industry. https://adaptive-clinical.com/2020-webinar3-optum/