Data required for clinical research comes from the patient care setting, which has been dramatically altered over the past decade with the near universal adoption of the Electronic Health Record (EHR).  Most clinical research requires that data captured during clinical care be re-entered into documents specifically designed for collection of research data, a process that is quite labor-intensive.  Around four years ago, Monica Bertagnolli, MD, a surgical oncologist with the Brigham’s Division of Surgical Oncology, decided that there must be a more streamlined way for researchers to collect patient data. As a surgical oncologist and clinical researcher, the process of reentering data already in patients’ EHR felt tedious and dated. That’s when she teamed up with Steven Piantadosi, PhD, a Brigham biostatistician and cancer clinical trial expert, to develop a concept known as Integrating Clinical Trials and Real-World Endpoints (ICARE) data.

Reaching “Burden Neutral”

Typically, collecting patient data begins with a patient being enrolled in a clinical trial, for which the participant gives specific permission to use their clinical data for research.  With the ICAREdata approach, the data required for research is then collected directly from the EHR, rather than relying upon transcription into redundant data collection tools.  The ICAREdata researchers had to overcome two important challenges for this to be effective.  First, the data collected in the EHR needed to be formatted in a standard fashion, ensuring that information collected across many different patients and treating centers could be combined. To do this, the ICAREdata team joined forces with researchers in the healthcare division of MITRE Corporation, a federally funded research and development corporation that aims to achieve broad public benefit by championing open source solutions to important problems in technology.  Together with MITRE and a number of oncology professional societies, a data standard for the EHR, known as mCODE, was developed and introduced into the Epic EHR, essentially solving the data formatting issue.

Now that all data collected could be properly formatted, the team tackled the challenge of making sure that all data essential for research could be captured completely during clinical care encounters without increasing the burden on already-stressed providers. This work is ongoing, with some important data requirements, such as response to cancer treatment, already being captured, and other needs, such as data indicating adverse reactions to treatment, soon coming online. The approach to minimizing provider burden has been to make any change “burden neutral.”  For example, if research data collection requires a new task, it must come together with an approach that reduces another required task or provides a new benefit to providers.

Capturing Real World Data

Through the Alliance for Clinical Trials in Oncology (Alliance), Bertagnolli and Piantadosi are testing ICAREdata collection in a number of active clinical trials for cancer patients.  Additional researchers at Mass General Brigham and DFCI have been key collaborators in this process, including Adam Landman, MD, Chief Information Officer at the Brigham, and cancer clinical trialists Kimmie Ng, MD, MPH, Jennifer Chan, MD, MPH and Ann Partridge, MD, MPH at DFCI and Priscilla Brastianos, MD, and Christina Ferrone, MD, at MGH.

Monica Bertagnolli

“Once ICAREdata methods are well established, it is reasonable to think of adopting them broadly, perhaps using them to collect data on patients who are not in clinical trials,” said Bertagnolli. “This would mean that data collected in routine clinical care could be more effectively captured, combined and used to improve health care delivery and responses to treatment.  This is the ‘real world’ part of the Integrating Clinical Trials with Real World data project.”

“Our goal is to expand the capabilities of cancer clinical research by introducing effective data collection methods into the electronic health record (EHR) of clinical care sites participating in clinical trials,” adds Bertagnolli. “These automatic data collection methods must provide the same level of accuracy as the traditional methods, but if successful, will substantially reduce resources required for clinical research, and dramatically increase the quality of data collected during routine clinical care.”

Building Trust

Because the ICARE project is being run through the Alliance, the investigators goal is for the work to extend to treating institutions, including both academic and community hospitals all over the country and even internationally. As of now, eight of the team’s clinical site partners have implemented ICARE data collection and extraction tools, with three other sites on the way as well. The team is attentive to addressing security concerns around patient data collection.

“Right now, we’re working on bridging the IT and clinical sides,” said Keri Safaii, an oncology nurse and director in the Alliance Data Innovation Lab working closely with Bertagnolli and Piantadosi. “We knew it would be a bit of an uphill battle and trust is huge with our site partners. There are many rules and regulations that we must follow on how we access and store the data. We have put a lot of time and effort into the development of data security plans, ensuring that we’re doing this right and keeping the patient and their data security as our top priority.”

“If we’re really going to make this work, it has to be a system where everybody participates,” said Bertagnolli.

Alliance has received several grants for this project, including from the Food and Drug Administration and the National Cancer Institute.

The ICAREdata team hopes their project will eventually expand to help people around the world.

“Of course at the Brigham, we’re all well connected. But we have sites in tiny towns in Montana and Puerto Rico and Texas,” said Bertagnolli. “With this kind of a method, we can expand our research to people in all of those locations too.”


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