Insights on Maximizing the Value of Clinical Registries and Accessing Real-World Data and Real-World Evidence

Clinical Registries are databases that contain carefully selected information on people with a particular illness or condition. These databases are retrospective and observational in nature. They must be built with agility, with room for expansion, as the study progresses. Clinical registries are a good source of Real World Data (RWD) and can be effectively utilized to gain vital Real World Evidence (RWE).

Navitas Clinical Research, a part of Navitas Life Sciences, aids in the efficient development and management of registries. We have vast expertise in managing clinical registries & other observational studies. In this blog, we interviewed Dr. Yun Lu, VP & Chief Science and Innovation Officer to explore what clinical registries are and how they can provide RWE.

Dr. Yun Lu

VP & Chief Science and
Innovation Officer,

Navitas Clinical Research

A clinical registry is a database that collects information about patients with a particular disease or condition. It is a valuable tool for clinicians and researchers to improve patient care, monitor safety and outcomes, and conduct research studies. Clinical registries are commonly used to track patient demographics, treatment patterns, and outcomes over time.

What are Real-World Data (RWD) and Real-World Evidence (RWE)?

RWD is data collected from sources outside of traditional clinical trials, such as clinical registries, electronic health records, claims data, and patient-generated data. RWE is used to provide insights of RWD into real-world patient outcomes, treatment effectiveness, and safety. RWD/RWE can be used to supplement traditional clinical trial data and can provide a more comprehensive understanding of treatment outcomes.

How Can Clinical Registries Provide RWD/RWE?

Clinical registries are an important source of RWD/RWE because they collect data on patients in routine clinical practice, which reflects the real-world population and care delivery. The data can be used to generate evidence on treatment effectiveness, safety, and quality of care. By using clinical registries for RWD/RWE, clinicians and researchers can identify trends and patterns in patient outcomes and treatment effectiveness, design and develop adaptive treatment and therapy for a patient.

What Are the Benefits of Using Clinical Registries with RWD/RWE?

Using clinical registries with RWD/RWE can provide many benefits, including improved patient outcomes and safety, enhanced quality of care, identification of gaps in knowledge and areas for improvement in patient care, and facilitation of evidence-based decision-making. By using RWD/RWE from clinical registries, clinicians and researchers can make informed decisions about treatment options and improve patient care. A registry can be very valuable to examine the use of certain approved drug or medical device, inform future clinical trial design, possible provide targeted participants for recruitment, care cost and policy decision.

What are some of the clinical registries that Navitas Clinical research has worked with?

We have worked with multiple U.S. federal Government agencies and foundations to support the development and management of clinical registries, including Centers for Disease Control and Preventions (CDC), The National Institutes of Health (NIH) and The U.S. Department of Defense (DoD).

Clinical registries and RWD/RWE are highly effective resources, particularly for the rare disease community, whose patients are sparse and widely dispersed across the globe. Registries provide a crucial opportunity for rare disease experts to collect and share vital clinical data, which aids in the development of treatments, advocacy measures, and networking efforts. Additionally, registries enable the storage of patient information that can be utilized for recruitment into clinical trials, thereby increasing the likelihood of meeting recruitment targets.

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