Patients can spend weeks, if not months, participating in a clinical trial and never see their healthcare data. For many, that’s a source of frustration. 

In a recent survey, 89 percent of patients said they wanted access to their own study data or results, and 91 percent wanted updates about the outcome of their study¹. 

Their expectations aren’t unrealistic. Participating in a clinical trial can be a daunting experience. Many patients have conditions that define the way they live, and out of necessity they are intimately familiar with their daily health status. When they join trials, they are often surprised to discover that their health data is suddenly inaccessible. When this inevitability isn’t addressed it may increase the risk of patient attrition, which costs sponsors up to $36,000 per drop out².

Demand for better data sharing isn’t just coming from patients. Sponsors are also facing pressure from regulators to create a more patient-centric research environment that supports a seamless exchange of healthcare data³.

The European Union currently has patient data sharing standards in place, including EU Clinical Trials Regulation 536/2014⁴ (Article 37), which requires sponsors to provide summary results of clinical trials in a, “format understandable to laypersons.” 

While the US Food and Drug Administration (FDA) doesn’t have explicit standards (yet) on collecting patient experience data, it is clearly moving in that direction. In 2018, FDA published draft guidance⁵ on how to collect patient data, and in 2019, it published a letter in support of open data-sharing⁶ through efforts like the Patient Safety Movement Foundation’s Open Data Pledge⁷. 

The message is clear. Patients want access to their healthcare data, and regulators are taking steps to make it possible. 

Time to change

Sponsors recognize that they need to make changes in the way they share data with patients, but this isn’t a simple problem to solve. In many cases, controlling data in trials is necessary to avoid compromising the outcomes. For example, if patients know they are not responding to a drug they may stop taking it, imagine negative consequences, or even drop out of the trial. However, much of the patient data captured, through wearable devices, physician visits, and lab tests, can be safely shared without impacting results. 

Historically, study related data was not shared with patients to reduce the risk of data being accidentally released and compromising the trial. However, many sponsors now recognize that sharing data back with patients can engender the patient’s commitment to the trial and create a more positive and collaborative experience. 

The desire to improve trial retention, and in response to regulatory expectations for a more transparent environment, pharma companies are now reconsidering their data sharing strategies, and seeking new ways to safely collaborate with patients.

Several large pharmaceutical companies are currently working with the Centers for Medicare and Medicaid services to launch a series of Patient Data Access Initiatives (PDAI)⁸ intended to improve patient control over their own health data. The resulting initiatives include the 2018 launch of MyHealthEData⁹, a platform that provides patients with tools to access, collect, and share their health data in a unified, interoperable manner.

Digital data sharing

On the clinical research side, technology companies are building platforms that can improve data connectivity between patients and investigators without compromising the integrity of the trial. These platforms offer features like patient education tools, updates on trial opportunities, reminders and alerts, andaccess to personal data once a trial begins. Data management tools let sponsors and investigators decide which data to share with patients and at what point in the trial, and to seamlessly integrate that data sharing process into the trial experience. 

These innovations will help pharma satisfy patient demands for access to their own healthcare data, while bonding them to the trial experience. When patients see the value they bring to the trial through research updates, their own results, and interactions with staff, it makes them feel like an integral contributor to the developmentof new treatments. This isn’t just beneficial for patients. It can have a direct impact on recruiting and retention, resulting in reduced time, cost and uncertainty from the trial process.

Patients as partners

As patients become proactive advocates of their own health, having access to their personal data is an expectation of clinical care. They bring the same expectations to the clinical trial process. As drug development focuses on smaller patient populations, sponsors must respond. Patients want to be treated as partners in this process and expect access to information about their own healthcare, and the outcomes of the research they agreed to be a part of. 

Purpose-built clinical data sharing platforms can create an engaging patient experience without compromising data security, and give sponsors, investigators and patients a safe way to exchange information, and honor the invaluable contributions that patients are making to the clinical research process. 

Simon Francis is the Director, Global Patient and Site Solutions, at IQVIA

References 

1. https://www.federalregister.gov/documents/2019/03/04/2019-02200/medicare-and-medicaid-programs-patient-protection-and-affordable-care-act-interoperability-and
2. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf
3. https://www.fda.gov/media/113653/download
4. https://patientsafetymovement.org/wp-content/uploads/2016/06/Signed-Patient-Safety-Letter-of-Support.pdf
5. https://patientsafetymovement.org/wp-content/uploads/2017/08/Open-Data-Pledge-Letter-PSMF-FT532A.pdf
6. https://healthitanalytics.com/news/cms-announces-patient-centered-data-sharing-initiative
7. https://ehrintelligence.com/news/myhealthedata-initiative-to-improve-ehr-patient-data-access
8. A survey of 863 responses from members of IQVIA’s patient communities, Jan/Feb 2019.