Bridging Clinical Research and Clinical Healthcare “Who Owns A Patient’s Data?”

I attended SCORR Marketing’s debut event Bridging Clinical Research and Clinical Health Care last week and I hadn’t had a chance to write up anything yet, because there was so much to take in. But suffice it to say, the conference presented a lot of great case studies, current practices, and inspiring ideas that could make clinical trials a more seamless treatment option for all people in the healthcare delivery system.

In honor of Mark Zuckerberg speaking to Congress about Facebook’s data breach in the Cambridge Analytica scandal, I thought we could tackle the issue of data in bridging clinical research and clinical care.

We hear a lot about how big data, data analytics, and integrated solutions could positively impact clinical trial design, recruitment, site selection and, on the discovery side, find potential therapies more quickly. As these are presented in articles, we do know that it is a difficult process to find or access the correct data sources to analyze and then provide “actionable insights” to that data.

I’m no fortune teller, but I would hazard a guess that any company performing analytics using other people’s data-forming algorithms to inform a hypothesis and substantiate a business decision-should be highly concerned with what data they have and what they are using it for. I would also say that Zuckerberg’s defense that he formed his company in a dorm room 14 years ago, and Facebook’s data practices were “reactive” and “naïve” to increasingly sophisticated advances in technology, is probably not going to be your best defense in 2018. Accountability and transparency are the words to use these days.

Aside from that, the hearings and #Bridging2018 puts on the table “who owns the data?” Zuckerberg maintained that Facebook users “own” their data. But in the healthcare world, patient data is a dicey area. It’s protected by HIPPA; in clinical trials, the randomized clinical trial process is de-identified patient data, and increasing calls for data sharing and transparency of clinical trial data is an ongoing effort. Many pharma companies offer access to their SAS clinical trial data sets, after a researcher asks for it and agrees to certain terms of usage.

Increasingly, the barrier to progress is not technology, but the view that the data is “owned” by a company or entity. CROs and pharma sponsors that have collected years of data on investigators became a competitive data set, and burden on investigators. For every trial and trial opportunity, investigators fill out the same questionnaires and submit the same forms over and over. Members of TransCelerate Biopharma, who spent time and resources hammering out their agreements with each legal department on pre-competitive data sharing, now use a shared resource of investigators databank.

During a panel session at #Bridging2018, members declared that data integration on the clinical trial level would be helped if it were EDC-agnostic, a single solution, that was developed with an open source spirit and had a convenient workflow. Above all, someone noted that pre-competitive data should be shared to improve trial efficiencies, and that data sharing must happen in order to move the bridge along.

TJ Sharpe, a cancer survivor, spoke at the Bridging conference. He shared his story of sheer perseverance in getting into a clinical trial, finally, for Keytruda, which made the difference in his life or death. Sharpe tweeted after the EHR Panel:

In March, Fortune magazine ran an article that eloquently explained to a clearly non-research or healthcare-based audience, the flurry of activity of mergers in the healthcare space is predicated on data. “More specifically, it’s your data: your individual biology, your health history and ever-fluctuating state of well-being, where you go, what you spend, how you sleep, what you put in your body and what comes out.” The article goes on to list all the data from lab tests, medical images, genetic profiles, liquid biopsies, ECGs to the data from medical claims prescriptions and research, which comes to 30% of the world’s data production.

But do you own that data? Many patients in clinical trials have never received a follow-up call about the clinical trial they were in, whether or not the trial was successful. They knowingly participate in a trial that may not help them, but they still do it for the advancement of science or to help others with the disease. But shouldn’t they at least get a thumb drive of their own results?

I looked up Judy Faulkner after reading TJ’s tweet. I did not know, but she is the CEO of Epic Systems, one of the top three EHR vendors. Epic’s About Us features its own humbling origins story of being founded in a basement almost 40 years ago, and its 190 million patients who have a current electronic record in Epic. It says that the software is used in patients’ home and in their pockets, but do the patients know who is using their data and why?

Harking back to clinical trials participants, I’m sure the average person would agree to share their (de-identified) data for the betterment of healthcare, or to help people who needed additional treatment options find a clinical trial quickly, or their tumor data to further the advancement of research. This is healthcare, it isn’t messing with the American democracy. The CEO of Aetna Mark Bertolini said in the Fortune article, he believes that consumers would actively want to be data-sharing partners, if companies can demonstrate how they can benefit from that cooperation. “We have all these rules about protecting data,” says Bertolini. “But if you turn it around and say to the customer, ‘If we have this information about you, we can make this a lot more convenient for you,’ he or she will give you the data.”

The consensus at #Bridging2018 was that the healthcare system consists of stakeholders with misaligned incentives. That is an understatement. As I said in this Pharm Exec article The Law of Unintended Consequences, “What is one company’s revenue stream is another company’s inefficiency. If you make it more efficient, someone is going out of business.” So, without pointing fingers, #Bridging2018 discussed a lot of pain points around the four topics of regulatory, technology, patients, and processes and ways to address them. We will continue to feature information about the conference, and what is planned for the future of bridging clinical research and clinical care.

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lisa.henderson@ubm.com. Follow Lisa on Twitter: @trialsonline