A Q&A with CEO, Cal Collins
Things are going great, and they’re only getting better.…The future’s so bright, I gotta wear shades.
Thinking about SMART on FHIR, I am reminded of Timbuk 3’s classic song, The Future’s So Bright, I Gotta Wear Shades. For a trot down 1980s memory lane, take a listen here.
If you are a frequent OpenClinica blog reader, you already know I am bullish about SMART on FHIR and its impact on the future – and current state – of clinical trials. Leading sponsors are adopting solutions driven by SMART on FHIR to unite medical care and research to keep up with the demand for new and repurposed therapies. After attending the DIA 2023 Global Annual Meeting in Boston, MA, I am even more certain of its practicality and traction.
At DIA 2023, media, clients, prospects, and industry leaders asked many important questions about SMART on FHIR and its promising future. Some of the insightful questions and my answers are below.
Question: What’s the current state of SMART on Fast Healthcare Interoperability (FHIR) and its impact on the usefulness of medical record data for research?
SMART on FHIR is a technology framework for apps to integrate with electronic health record systems (EHRs) in a way that is reusable, platform independent, and, in the US, has been widely adopted and supported by EHR vendors and healthcare providers. It provides a very consistent way to do data integration across the many sites that are usually part of a clinical trial.
SMART on FHIR has become widespread, in part, because the standards are mandated through a set of regulations, the 21st Century Cures Act, the HITECH Act, and the Office of the National Coordinator for Health Information Technology (ONC) certification criteria. You can go in with the expectation that there’s going to be support and availability for doing an integration in that way, even if you haven’t previously worked with the site. That’s a huge difference from the past – where everything was custom, unique and a special snowflake and integrations seemed unattractive compared to manual data entry. It’s really exciting that’s starting to change.
For OpenClinica clients, our out-of-the-box implementations now require less than 20 hours of effort. They are happening rapidly, and we are quickly growing our network of connected healthcare systems. What we also do is tie the data acquisition to a really rich workflow system that gives value back to the users because it can help identify what they need to do today. Logic can be built into a specific trial that presents users with data back at the point of care as they’re opening their patient chart, data that may be useful for the trial either for operational and logistical purposes or even safety and clinical use.
Question: Why are you so passionate about SMART on FHIR?
Many people agree interoperability is critical in healthcare and, over the years, has been done in a very limited or poor fashion. The first time I learned about how the SMART on FHIR technology works was an eye-opening experience. The idea of pluggable standards based on a reusable framework and modern technology – not technology approaches from the 1970s – is extraordinarily refreshing. We are seeing wider adoption in more and more areas of healthcare, a development that excites me and makes me hopeful about the future.
For clinical trials, interoperability and SMART on FHIR mean we can use information that already lives in electronic form nearly instantaneously for research. Too many clinical trials still depend on an incredible amount of manual labor to transcribe information. That’s wasteful, it’s error prone, and it’s nobody’s highest and best use. It doesn’t have to be this way. SMART on FHIR is a gamechanger for clinical trial sponsors, CROs, sites and academic research organizations.
Question: How would you summarize the impact of SMART on FHIR on the usefulness of RWD?
SMART on FHIR unlocks the power of real-world data (RWD). It improves the clinical workflow, enables clinical trials to integrate RWD in a non-disruptive way, and ultimately reduces burnout among clinical trial researchers.
Question: How does SMART on FHIR impact the user experience?
In short, SMART on FHIR eliminates heaps of manual work.
Before SMART on FHIR, clinical researchers typically needed to log into two systems simultaneously with different logins and hunt for the right value in the EHR, navigating far too many screens to manually transcribe to the eCRF (electronic case report form). The results were fewer data points transcribed, higher costs to verify data quality, and an inability to rapidly access data.
Now, with SMART on FHIR, researchers use one click to securely launch the eCRF from the EHR patient chart and automatically populate the eCRF with source data. This eliminates time-consuming and error-prone manual data entry and delivers many, many downstream benefits, such as lower SDV (source data verification) and higher-quality data for early decision-making by sponsors and stakeholders. Ultimately, it means therapies get through clinical trials safer and faster.
Question: What does the near-term and long-term future of SMART on FHIR look like? What needs to happen to realize the long-term future?
Applied Clinical Trials asked these questions. Watch the interview here.
Question: What sort of hoops do you have to jump through for the FDA to be on board and support what you’re doing [with SMART on FHIR and OpenClinica Unite]?
Liza Laws, Senior Editor, Outsourcing-Pharma & BioPharma-Reporter, asked me this question. My response was:[OpenClinica] has had the opportunity to collaborate closely through a customer of ours, Quantum Leap Healthcare, who powers the I-SPY adaptive platform trials, and the University of California, San Francisco, to really explore some of the questions and related relevant topics. We look carefully at the guidance the FDA has issued around e-source and use of electronic health record data to make sure that when we’re doing an implementation and setting up a study, we adhere to all those requirements, carefully tracking where data came from making sure that in the audit trail that it’s traceable back to source being a certified EHR system.
Question: How will SMART on FHIR impact the broader supply chain?
Pharma Commerce Editor, Nicholas Saraceno, asked this question. To view my answer, visit the Pharmaceutical Commerce website.
Question: How does OpenClinica use SMART on FHIR technology for automated source data capture?
OpenClinica Unite automates source data acquisition from patient medical record systems (EHRs) to clinical trial research databases (EDCs) and case report forms (eCRFs) to view study data safely, accurately and efficiently. The OpenClinica Unite EHR integration is built on Part 11-compliant electronic data capture (EDC), has traceability to source (data originator, data element identifiers per FDA 2018 EHR guidance) and synchronizes data and builds reconciliation workflows per trial needs. It can also work with other non-OpenClinica EDCs.
This secure, validated bridge between healthcare and research data eliminates manual data transcription and is especially suited for rigorous GCP and Part 11-compliant clinical trials.
In other words, sites and sponsors can auto-populate their EDC and eCRFs on study day one with OpenClinica Unite.
SMART on FHIR Resources:
- Download the OpenClinica playbook, Fast-tracking clinical trials with automated source data capture,
- Listen to my interview with Applied Clinical Trials,
- Watch Pharma Commerce Editor, Nicholas Saraceno, interview me,
- Read the transcript of my discussion with Liza Laws, Senior Editor of Outsourcing-Pharma & BioPharma-Reporter.