Voices from Within: Conversations on DCTs & Data Privacy

In a time when healthcare has adopted technology and data collection software at an exponential rate, it is important to educate patients and stakeholders on what that standard for patient data collection should be. In Episode Two of Voices from Within: Humanizing Clinical Research Data, Curebase experts share a comprehensive overview of how patient data is collected and how data is protected. This 15-minute Flash Webinar was led by Vice President of Clinical Trial Innovation at Curebase, Jane Myles, Vice President of Clinical Trial Operations at Curebase, Sean Lynch, and Type 1 Diabetes clinical trial participant, Phyllis Kaplan. 

Jane started the webinar by sharing a bit about Curebase’s mission, which is to allow patients to easily participate in clinical trials from anywhere. “We aim to modernize clinical trials and make them more aligned to the preference of patients and physicians. Ultimately, the work we do at Curebase is to help increase participation in trials so that researchers can get the data they need,” Jane shares. 

Before understanding the various methods used to protect patient data, it’s important to know the foundational process of clinical trial management. All data begins with patients and is collected through sources like wearable devices, questionnaires, or lab results from testing. After data is collected, it then is collated and stored, a process through which the data is organized and anonymized. 

Once data leaves a research site, it is coded by a number, anonymizing the patient’s information to ensure their protection and to ensure an unbiased study of that data. “Many patients participating in a clinical trial may think that the Principal Investigator (PI) or research team of their study have access to their data, but this is not the case,” Sean explains. 

The anonymized data is organized into data sets that can be used for statistical analysis. These data sets hold the information that are used to answer the question posed by the study and determine if the endpoints for safety and efficacy have been met. 

“That is ultimately the key outcome of every clinical trial, collecting those sets of data,” Sean says.
“Once this data is collected and stored, it’s then shared with the FDA and other regulatory agencies who will cross-check to ensure its accuracy.”

Looking at the numbers, one may think that finding data sets is where patient data collection ends in a clinical trial, but this isn’t the case for many of the participants. Once a trial concludes, many patients have lingering questions about their data privacy and the results of the study they were in that go unanswered. 

Phyllis Kaplan, a Type 1 Diabetes advocate, has participated in 5 clinical trials, most frequently for wearable medical devices. When joining these studies, she remained largely uninformed by her research team about where her data was going. 

“I didn’t ask a lot of questions, only because I felt that since I had already agreed to participate in the study there wasn’t room for push-back about data collection. It appeared to be an all-or-nothing choice,” Phyllis reflects. 

This is a common problem voiced by many patients when a study concludes. When joining a clinical trial, oftentimes patients aren’t aware what questions they should ask about their data and what their rights to privacy are. 

“In my experience, there is often a gap in communication to participants. Once the trial is done, I would love the loop to be closed where we receive thank you messages for participating and are informed how our data is being used,” Phyllis shares. 

Beyond, understanding where their data is going and how it is being protected, many study participants also are unaware of the overall outcome of the trial they participated in. Phyllis shares that of the 5 clinical trials she has been in, she’s never received any follow-up regarding the trial’s overall success or results. “If my data can shed light on a new treatment or advancement, I’m all for it,” Phyllis says. “I just want to be made aware of that as a patient.” 

This problem is what many who work in clinical trials refer to as a ‘data black hole’ and what industry experts are hoping to solve. “Sponsors need to step up and find appropriate ways to get a certain amount of data back to patients in a timely manner. This will add value to their experiences,” Sean says. 

Ultimately, the conversation provided several important takeaways regarding data collection and privacy: 

  • Not enough patients learn about where their data goes, how it is used, and the overall outcome of the study they participated in.
  • Patient data is protected through anonymization and not attributed to the individual.
  • A big opportunity exists to educate patients about data privacy and how to ask the right questions about data when participating in a clinical trial.
Learn more about patient data collection by accessing the webinar recording here. View CISCRP’s library of webinars and podcasts here. 
To search for medical conditions in a specific location, visit our Search Clinical Trials page. 
To stay informed about clinical trials, visit our Resources page. 
To learn more about Phyllis’s work as a Diabetes advocate, read her Medical Hero article here.

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