Acquiring, curating, and reusing data to deliver lifesaving therapies

EXECUTIVE BRIEF

Pharmaceutical and biotechnology companies focus on producing drugs and other products that help people live healthier lives, recover from injuries, and fight illnesses. These critical, life-enhancing advances are achieved through a combination of practical evidence, engaged patients and physicians, and standardized reusable data.

Bringing therapies to market relies heavily on clinical trials. But challenges with sharing data from electronic health records (EHRs), specialty pharmaceutical companies, and clinical research organizations can create longer timelines for drug delivery. In an ideal setting, clinical trials should combine material evidence and EHR data, as well as information from patient wearables to gain analytics that ensure strong drug performance in therapeutic areas and vaccines.

Improving medical treatments requires advanced research that relies on studies that are reliable, easily accessible to participants, and open to wide range of people. It would seem that the public agrees with this sentiment—at least in the US—where “roughly 4 in 5 adults said it’s important that clinical trials are easy for participants to get to and that they’re diverse,” according to a poll by Morning Consult.¹ In addition, more than half the participants in the poll stated they “would consider joining a virtual trial.”

The status quo is not the answer

Many clinical trial approaches today are manual, slow, and costly. Pharmaceutical and biotechnology companies design their own forms-based tools for data gathering. The individuals responsible for developing the tools need to recruit clinicians to help them identify patients, while pharmaceutical and biotechnology companies attempt to stem attrition rates for both patients and clinicians. Unfortunately, for many of these tools, developers wind up dealing with a lack of interoperability, an inefficient forms processing system, and mountains of data on paper. Trials need data that’s formatted and computable so that clinicians can quickly extract meaning from it.

The pharmaceutical industry relies heavily on spreadsheets and manual transcription of data to manage all the information from clinical trials. Complex storage of paperwork, difficulties in searching data, and inefficiencies with moving through all the various steps toward therapy approval, hamper overall effectiveness and efficiency. And the more companies rely on manual processes, the higher the probability of error.

Greater accuracy and efficiency would be achieved if pharmaceutical and biotechnology companies could acquire, curate, and reuse virtually any type of healthcare data at scale. To accomplish this, companies should work with a technology partner that has market-leading expertise in Fast Healthcare Interoperability Resources® (FHIR®) API management—since the FHIR standard can be used to tap into and use legacy data and convert it to a usable format. The guidance from such a partnership could help shift organizations to the cloud and help them move fast, preserve capital, and offload management of information technology (IT) systems that are readily available and secure.

A pharmaceutical or biotechnology company’s expertise grows from clinical trials and medication development and distribution, not via data acquisition, curation, and interoperability standards. This makes it all the more critical for companies to seek external support to ensure they can quickly deliver therapies and vaccines that save and enhance lives.