The Rising Popularity of Clinical Patient Registries and their Importance in Building Healthcare

In this blog, three seasoned experts share their insights and expertise regarding the growing significance of patient clinical registries and their pivotal role in building our healthcare systems. Dr Yun Lu, boasting decades of experience in developing and managing patient registries, serves as the Chief Science and Innovation Officer at Navitas Life Sciences. Sarah W. Lawrence, a Senior Clinical Project Manager at Navitas Life Sciences, brings forth her wealth of knowledge garnered through multiple years of experience. Joining them is Andra Matthews, also a Senior Clinical Project Manager at Navitas Life Sciences, contributing her expertise to enrich the discussion.

What is a clinical registry?

Clinical patient registries serve as invaluable repositories of information, drawing voluntary contributions from individuals afflicted with specific diseases or conditions. They offer insights into the intricacies of various medical conditions.

Clinical trials registries and clinical data registries occupy prominent positions. Clinical trial registries serve as repositories for data collected among clinical trials that are conducted across a particular region, while clinical data registries offer an interface where collecting, organizing, and presenting healthcare information is carried out in a cohesive manner.

What is a clinical data registry?

It is a database, meticulously designed to store a wealth of healthcare data. They are also referred to as patient registries or disease registries. While medical associations and specialty societies predominantly employ the term "clinical data registry," patient foundations, governmental bodies, and research institutions may lean towards "patient registry."

The term "registry" includes data collection and the records meticulously generated. Patient registries, in particular, stand out in the landscape of health information systems. Defined by E.M. Brooke in a 1974 publication of the World Health Organization, these registries are characterized as compendiums of uniform information about individuals, methodically compiled to serve predetermined objectives.

The scope of registries extends beyond mere data collection, encompassing a spectrum of purposes in public health and medicine. Patient registries facilitate the collection, storage, retrieval, analysis, and dissemination of information pertaining to individuals afflicted with particular diseases, predisposing conditions, or prior exposures to substances known to cause adverse health effects.

What is a Qualified Clinical Data Registry (QCDR)?

A QCDR stands as an entity approved by the Centers for Medicare & Medicaid Services (CMS), which could include specialty societies, certification boards, or regional health collaboratives. Its primary function is to gather medical and/or clinical data aimed at tracking patients and diseases, with the ultimate goal of enhancing the quality of care delivered to patients.

Clinical Patient Registries: Their Rise, Real World Evidence and Beyond

The insights on patient registries were recorded by the experts exclusively for the blog. Read on for some interesting and exciting updates.

Dr Yun Lu

Chief Science and
Innovation Officer,

Navitas Life Sciences

Please elaborate on the key findings of the best practices for utilizing real-world evidence in clinical registries?

Real world data (RWD) and real world evidence (RWE) integrate more closely with today’s clinical research. It is important to consider the following points when planning and implementing a clinical registry program:

• Start a clinical registry with landscape analysis and study plan, incorporate scientific rigor to inform the registry development and road map.
• Identify the stakeholders as early as possible as it will determine and drive your registry governance and policy, focus on patient centric need.
• Evaluate the operation skills required to implement a clinical registry program, define resources and specialties to run a registry program including balanced consideration of the internal expertise and capacity and the need of an experienced CRO to server as the coordinating center.
• Consider registry data sources, platform selection and modern technology
• Last but not least, achieve clinical registry sustainability, including consideration of funding sources, development of public-private partnerships to finance ongoing activities, and appropriate use and sharing of data.

You have worked with multiple US federal agencies and disease foundations, supporting them on multiple clinical registry projects. What has been your experience and your biggest takeaways from such projects.

Understanding the differences between clinical trials and clinical registries is very important before planning and implementing a registry program successfully. Clinical registry studies are based on Real world data (RWD) and Real World Evidence (RWE), including data of patients from standard care, patient reported outcomes, and patients’ information of medical history and other information. Some clinical registries also include data from caregivers. The clinical registry specific considerations should be included for protocol design and strategy; IRB and regulatory consideration; data and data sources; eSolution choices, system integration and inter-operability, especially EHR/EMR data vs. clinical research data; stakeholders; data sharing; data insights and secondary uses, and sustainability.

Please provide specific examples or case studies to highlight the successful implementation of best practices in clinical registries using real-world evidence.

A disease specific registry study was awarded to Navitas Clinical Research (NCR) (A part of Navitas Life Sciences) as a “rescue” project that was being managed by another CRO. The project goals were to provide registry operation and regulatory support to the sponsor and the sites, and serve as the Data Coordinating Center, including:

• Developing a user-friendly registry system
• Ensuring effective data management and quality control without burden to the sites
• Supporting data harmonization and integration across multiple sources and support system interoperability across multiple applications
• Providing data availability and analytical support to the sponsor and the researchers
• Supporting data sharing with larger disease specific communities and the sponsor’s teaming partners

Our deep experience in managing registry program, building registry platform and supporting meta-data driven data harmonization and system integration was leveraged to develop and implement this registry program. The solutions included:

• Efficient and effective full service Coordinating Center support capabilities
• Operation and regulatory support, site support, monitoring system and system interoperability, data management, data harmonization and integration across multiple sources, data analysis and visualization
• Tailored capabilities catering to the client’s unique needs

Sarah W. Lawrence

Senior Clinical Project Manager,

Navitas Life Sciences

What challenges do you face while setting up clinical registries and how do you overcome them?

Sponsors can unknowingly establish clinical registries in the same way they would a clinical trial. Clinical trials are typically designed to obtain limited data with the goal of obtaining market approval or satisfying a specific regulatory milestone. Clinical registries, on the other hand, provide Real World Evidence by collecting data from a specific patient population across multiple clinical sources, and this evidence has the far-reaching potential to inform clinical care, research landscapes, and public policy. Given this immense potential for clinical registries to impact disease standard of care, sponsors should take care to define a specific purpose for their registry. Lack of purpose can result in poor quality data due to improper protocol design or scientific rigor. The scope of a clinical registry should not be so broad that the data that is generated cannot be applied to the respective field of study. Sponsors should also seek guidance from relevant stakeholders when establishing a clinical registry. Guidance and feedback from these stakeholders are crucial to the success of a registry by providing direction in crucial aspects of registry implementation including protocol design, regulatory approval and reporting, and operational considerations.

One of the focuses of the article is on data quality and integrity in clinical registries. Can you elaborate on the strategies recommended for ensuring the reliability of real-world evidence collected through these registries? How are high standards of data quality maintained?

The success of a clinical registry depends on a fully functioning Registry Coordinating Center to provide support for registry operations, regulatory support, and data coordination. These three areas are key to maintaining data integrity by ensuring that the data collected in a clinical registry is reliable and of high-quality. A successful Registry Coordinating Center is made up of a team of experts that ensures that the data collected across multiple sources is accurate, adheres to appropriate local and federal regulations, and has been quality reviewed. This team should not only set up appropriate systems at the initiation of a clinical registry, but they should also have the knowledge and experience to maintain high-quality systems and platforms throughout the registry life cycle, including planning for sustainability by making recommendations for how to implement advancements to adapt to research and technology advancements in the field.

Scalability and interoperability are essential aspects of successful clinical registries. Explain the context of integrating data from multiple sources and accommodating diverse research needs?

Clinical Registries are an important method for generating Real World Evidence by collecting patient data across multiple sources including Electronic Health Records, claims data, and research studies. However, it’s important to consider that these sources can be fundamentally varied in origin and collection method. Clinical registries recognize that this is the case and build appropriate systems and analytical methods to account for and perform quality control on data from these disparate systems. Not only is it important to build these systems from the start, but it’s essential to constantly revisit data sources for a clinical registry, seek guidance from relevant stakeholders, and maintain up-to-date knowledge of advances in clinical data science to be able to scale data collection methods in a clinical registry. This ensures that the data being collected for a registry is consistently meeting its objective and will be relevant in real-world settings.

Andra Matthews

Senior Clinical Project Manager,

Navitas Life Sciences

Andra, communication and collaboration among stakeholders are crucial for the success of clinical registries. What are some effective strategies for facilitating collaboration between healthcare providers, researchers, and regulatory agencies in the context of real-world evidence analysis?

Collaboration with healthcare providers, researchers, and regulatory agencies in the context of Real-World Evidence (RWE) analysis is essential to ensure the accuracy and reliability of real word data. One effective strategy for collaboration is establishing clear communication channels with health care providers to discuss study objectives, data collection methods, and interpretation of results. Additionally, involving healthcare providers in study design and planning can help ensure that the research is relevant to clinical practice and patient outcomes. It is also important to actively involve regulatory agencies in the process, as their expertise can provide valuable oversight that may not be apparent to healthcare providers and researchers. Furthermore, fostering a collaborative and respectful relationship between healthcare providers, researchers, and regulatory agencies can help build trust and facilitate ongoing collaboration on future projects. By implementing these strategies, researchers can enhance the quality and impact of RWE analysis in healthcare.

As real-world evidence continues to gain importance in regulatory decision-making, how can pharma companies leverage our capabilities in designing and managing clinical registries effectively?

As Real-world evidence (RWE) continues to gain importance in regulatory decision making, pharma companies should consider leveraging our capabilities in the design and management of clinical registries, as it can provide valuable insights into the effectiveness and safety of medical interventions in real-world settings. By leveraging our capabilities and incorporating RWE into registry design, researchers can enhance the quality and relevance of data collected, leading to more insightful analyses.

RWE can help identify potential biases and confounding factors that may impact the validity of study results, allowing for more accurate interpretation of findings. Consequently, leveraging our capabilities in clinical registries is essential for informing treatment decisions, optimizing patient outcomes, and ultimately improving the quality of healthcare delivery.

Are there any emerging trends or technologies that may influence the future of clinical registries?

The future of registries is being shaped by various trends and technologies that are revolutionizing the way information is stored and accessed. One key trend that is influencing registries is the increasing popularity of data coordinating centers. The DCC collaborates with teams to enhance data system usability, function, and compliance.

Another key trend is the increasing adoption of electronic health records (EHRs) and interoperability standards, which will enable seamless data sharing between different registries and healthcare systems. This will result in richer and more comprehensive datasets, leading to more robust research and improved patient care. Additionally, the growing use of machine learning algorithms in healthcare may allow for more sophisticated data analysis and predictive modeling within registries, ultimately.

Best Practices for Clinical Registries While Leveraging Real World Evidence

By Dr Yun Lu, Sarah W. Lawrence, Andra Matthews

Find out the difference between clinical registries and clinical trials, and get exclusive insights on building a robust clinical registry, in our article.

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Published by:

March 4^th 2024

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