Patients, data, and making it all work together: Using RWD in research

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/asiseeit)
(Image: Getty/asiseeit)
Using RWD and RWE to make data actionable and patient centric can be a gamechanger in the health care industry’s research capabilities, according to LMC Manna research executive.

During ACRP 2019, Karri Venn, president of research at LMC Manna, gave a talk regarding real world data (RWD) and real world evidence (RWE) as a part of the evolving research landscape. Venn stated in her discussion that big data is roughly all the data that has been collected over the past 20 years, and the goal of using it in research is taking that unstructured data and making it actionable.

“Real world data produces real world evidence,”​ said Venn – and by taking that data and making it patient specific, it can help define better health care pathways by mitigating risks, improving trial recruitment, and potentially accelerating a drug’s path to market.

Social media and electronic records

Ken Getz, director of sponsored research programs at Tufts University touched on data as a tool in clinical research. He said that electronic health records (EHRs) and RWD play a "growing role in supporting the primary dataset."​ 

With the ‘explosion of technology’ in the last decade, Venn told us there have been major advances in opportunities to collect RWD through sources beyond EHRs such as mobile and wearable devices. These technologies can create structured data sets.

Additionally, Venn said social media has played a role in collecting data. Venn cited the website “Patients Like Me,” which provides a structured electronic format to collect patient behaviors, emotions, and current challenges across all therapeutic areas.

Conversely, Getz said that pharma has high expectations for growth in data collection except for social media which has been a challenging area.

No matter how it is collected though all of this information is imperative to RWE and RWD based research, Venn said: “Understanding the emotional drivers, behavior trends, are invaluable input to a patient centric solution when designing a study.”

Venn stated that the type of RWD that can enable researchers to understand emotional drivers and behaviors can be collected from patient conversations, electronic medical records, patient habits and routines among many other patient specific components. Getz also stated that nearly every company participating in RWD have been collecting and sharing data to support key clinical research areas to improve greater science. 

In combination with social media, standardized electronic records also lend a hand in collecting patient data in a structured format, according to Venn. She added that this data can be analyzed by bigger, faster computers that can find trends for RWE outputs. 

Another piece of the data collection puzzle is the MyStudies App, she said. Released in November of 2018, Venn said the MyStudies app can improve overall compliance of data collection. The app collects data by using patients’ own devices through patient reported outcome (PRO) questionnaires and can be used by researchers to make RWD and RWE active parts of research.

Venn made a point in her session to state that with ‘good data,’ ‘good standards’ can be established, and the industry can use those standards to empower patients and collect data. The US Food and Drug Administration (FDA) recently released a strategic framework for the use of RWE​ to support drug development. Per the framework, standards for methodologies for collection and analysis have become a priority.

Getz also stated that data has become a priority for the industry. He said in his address that data and analytics can enable clinical researchers to act in real time and predict ways in which to adjust models to provide efficiency and cost reduction.

He went on to point out that artificial intelligence (AI) has also been a tool to in the growing role of data and the diversity of data. AI emables target identification and will position the health system to be a more dominant place to conduct research because of the organized and diverse data.  

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