Patients Can Expand Access To Clinical Trials, If They Have The Right Tools

By Komathi Stem, founder and CEO of monARC Bionetworks.

Komathi Stem

The FDA released guidance last year noting that electronic health records (EHRs) have the potential to improve clinical trials, leading to greater safety and efficacy. But tapping that potential, according to the agency, requires interoperability — the ability of two or more products, technologies or systems to 1) exchange information, and 2) to use the information that has been exchanged without special effort on the part of the user.

The healthcare industry, driven by meaningful-use requirements, is focused on wider efforts to promote interoperability. Many of them emphasize technology, including advances such as Fast Healthcare Interoperability Resources (FHIR) tools and Substitutable Medical Applications, Reusable Technologies (SMART) standards. But while the technology is crucial, it is equally as important to recognize the group of stakeholders who could play a critical role in making systems more interoperable, and thus improve the clinical trials process:

The patients themselves.


Interoperability has the potential to help increase care coordination, improve safety, support patients in making the most informed healthcare decisions, reduce costs, and help public health and health promotion efforts. In addition, interoperability can have a role in drug development, as the 21st Century Cures Act mandates that the FDA include Real-World Data (RWD) — data gathered during routine clinical care – in regulatory decision making. This RWD can be in part derived from the EHR-generated data, standardized and shared through the interoperability process.

The growing availability of information (digital health data is increasing by 48 percent each year) creates the potential for better patient care, including improved clinical trials. Unfortunately, despite strides made in interoperability, data in medical records are still too often packaged in ways (i.e., handwritten notes and medical device feeds) that are hard to share or standardized.

The stakes are high. According to the FDA, “Non-interoperable systems, without the capability for electronic exchange of EHR data in clinical investigations, involve manual transcription of data elements … or to the paper case report form, similar to the transcription performed with paper records. Such manual transcription procedures may introduce risks of data entry errors unless effective quality control systems are in place.”

How patients can help researchers — and themselves

Interoperability increases access to patient information that can help researchers recruit the right participants for clinical trials, and even inform better research questions and the investigation of symptoms that matter more to patients. But relying solely on technologies and interoperability is not a complete strategy; patients can help plug the gaps. For researchers, being able to tap into that data means they will have more options when they are looking for clinical trial participants. The data available could, for example, help researchers in New York find the right participant for a treatment group in New Mexico, or the right participant for a control group in New Orleans.

Of course, patients willing to participate and actively engaged in the data aggregation process, have the opportunity to end up in treatment groups where they receive cutting-edge care — and even if they end up in control groups, their participation can be useful in the researchers’ work to find solutions. At the same time, using the curation tools can help patients as they receive day-to-day care outside of trials. The aggregation of the medical records and patients’ ability to easily share their own information makes it easier for doctors to get a full picture of a patient’s medical history and ongoing treatment.

Why this is important

Providing the right tools for patients to participate is crucial in the larger push for interoperability. With such tools, it is possible to further engage with patients, who — through the continuous sharing of their health data in a way that protects their privacy — can accelerate recruitment rates and reduce the costs of developing new therapies. Additionally, researchers need not spend as much time on medical history retrieval and screening time — and instead focus on the trial itself.

Empowering patients with tools that make it simple to consolidate and share their medical records with researchers will transform and accelerate clinical research, bringing new therapies to market faster and at lower costs. This approach will also deliver better care today to those patients with access to these tools.

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