‘Nothing about me, without me’: DIA panel addresses patient data and the future of research

“We progress faster when the knowledge from many is integrated,”​ said Barbara Lopez Kunz, global chief executive of DIA at the association’s 2019 annual meeting last week. “We are on the precipice of a massive data-driven change,”​ she continued, leading off the session which addressed collaboration among industry stakeholders – and importantly, with patients.

Joanne Waldstreicher, MD, chief medical officer, Johnson & Johnson, said the industry has “​shifted from doing things and making decisions on behalf of patients, to really working with patients together as partners, co-creating clinical trials, co-creating endpoints, making benefit/risk decisions with patients, with the people who count the most.”​

“We can do much more working together toward a common goal,”​ added Guido Rasi, MD, Executive Director, European Medicines Agency (EMA), who noted that as a regulator, the agency needs to work with a growing number of stakeholders, including researchers, companies, investors, patients, and others.

Providing his viewpoint from the US, Gary Gibbons, MD, Director, National Heart, Lung, and Blood Institute, NIH, said the source of the institute’s excellence is diversity and inclusion: “The best ideas come from the community​.”  

On the future of research: ‘Nothing about me, without me’​​

Harlan Krumholz, MD, Harold H. Hines, Jr. Professor of Medicine and Director CORE, Yale University, expects the future of research will be site-less, digital, and in real-time. “I think we’re on the cusp of a very different paradigm,”​ he said during the opening session. “We simply cannot continue to do research at the price and timestamp we are.”​

As part of this paradigm shift, Donna Cryer, JD, interim executive director, People-Centered Research Foundation, said there is “an incredible opportunity”​ to make sure that research is “people-centered.” ​

“What that means, in reality, is that data is not just a concept of a fuel going through a pipeline, but really it is the information about people’s lives that should be used to improve people’s lives, and the best way to do that is through partnership with the patient,”​ she explained.

Cryer added, “The potential of tapping into the questions that people have, the experiences that patients live through, and combine them and really embedded them much more firmly than ever before can create a whole new landscape for research.”​

Fueled by recent big tech scandals and some in the research sector around how companies are monetizing data, Deven McGraw, JD, LLM, MPH, chief regulatory officer, Ciitizen, said “more and more patients are tired of being on the sidelines.”​

“It is data about them and whether they own it or someone else owns it isn’t really the issue, it’s that it’s about me, it’s sensitive to me,”​ she said, stressing that patients want to be included in the process of making decisions about their data. “Nothing about me, without me”​ is becoming a very salient theme, McGraw added, further noting that there has never been zero risk of reidentifying patient data.

“We treat it as if it has zero risk in the law and in that way that we handle it .. and I think that’s a mistake,”​ she said. And this risk is compounded by the amount of data available about any given patient. In fact, a recent study conducted by the University of California, Berkeley​, found it possible to re-identify individuals using their physical activity data – with current laws and regulations failing to safeguard confidential health information.

The concerns follow several advancements in artificial intelligence (AI) since the passing of the Health Insurance Portability and Accountability Act (HIPAA) more than 20 years ago​.

“It is wrong for us to wave the magic wand and say we’ve deidentified it,”​ added McGraw, who said her challenge is one of building trust. “You want to give [patients] agency, but it’s too much to say they consented and therefore it was okay ... It’s not more acceptable to just do that than say it it’s deidentified so, therefore, it’s okay​.”