Why Foundations’ Disease Registries are important and how they are different from Clinical trials

Registries are a carefully curated database of people with a specific disease, it is observational and retrospective. They need to be built with agility and ability to be improved or expanded as the study continues.

Navitas Clinical Research Supports Efficient Registry Development and Management

Navitas Clinical Research, a part of Navitas Life Sciences Ltd, is a full-service CRO supporting diverse clients with the design, execution, and result analysis of their observational studies, registries and clinical trials.

Our nearly three decades of experience enables us to predict needs, avoid common barriers, and move from a quick start-up through each development phase to a successful execution of your project.

Navitas Clinical Research’s Key Steps to efficient Registry Planning and Management

  • Clearly Defined Purpose
  • Determination of vital stakeholders
  • Assess the feasibility
  • Establish a well-defined plan
  • Calculate data set and identify the target population
  • Develop a protocol and a project plan
  • Provide training to foundation staff on registry support
  • Ensure periodic critical evaluations

Registries contribute towards scientific advances

Patients with a specific disease, especially one that is not well understood or rare, may find it difficult to get the support they need. The lack of knowledge about the disease or diagnostic expertise could affect care and understanding. Registries, therefore, help plug these gaps and could also play a role in developing new therapeutics.

In order to understand more about registries and their development, we interviewed Dr. Yun Lu, Vice President & Chief Science and Innovation Officer, Sarah Lawrence, Sr. Clinical Project Manager, and Mike Garber, Executive Director.

Tell us more about yourself

I am the VP& Chief Science and Innovation Officer at NCR. I am a PhD level clinical data scientist with extensive experience working closely with several National Institute of Health (NIH) Institutes on complex multi-stakeholder projects and public private partnerships. I have provided this service for a wide variety of Phase I- IV clinical trials and disease registries in various therapeutic areas. I bring more than 20 years of experience leading efforts with clinical data, data standard and therapeutic and disease specific common data element (CDE) development and implementation, meta-data driven harmonization, and information technology integration, process development and validation life cycle support.

What is the purpose of a registry?

A registry is a purpose-specific database with the defined disease conditions and real-world patient population to track disease progress, and to help improve treatment outcomes, quality of care, exam certain approved drug or product, and inform future clinical research and policies.

Dr. Yun Lu,

Vice President & Chief Science and Innovation Officer

Navitas Clinical Research

IDMP

What are some of the registries in healthcare?

Patient registries can be categories by various ways. Registries can collect data directly from patient or clinicians or both. Example of the registries in healthcare include but are not limited to: patient reported outcome registries, disease registries, medical device registries and more.

How do registries impact healthcare?

The registry could help evaluate comparative effectiveness of treatment approaches for informed patient care, i.e., what types of interventions work best in what types of patients. Data integration would help providers, health systems and payers as well as patients.


Tell us more about yourself

I am a Sr. Clinical Project Manager with a background in genetics and public health. I have 11 years’ experience in clinical trials and community-based research in the academic and private sector in topics including chronic disease, oncology, and dementia. I have been involved in research projects, clinical studies and patient registries. Currently, I serve as a Project Manager leading a large CNS Genetic Registry program and a longitudinal, multicenter, international registry collecting data on the performance of device technology and health outcomes in patients with pancreatic cancer.

What are some of the organizations that you have supported in building registries?

I have supported US-based non-profit organizations that use information from registry studies to promote awareness and encourage innovation and investment in treatments.

Sarah Lawrence,

Sr. Clinical Project Manager

Navitas Clinical Research

What are the different types of registries in healthcare?

Non-profit organizations, hospitals, and research institutions use registries to compile information from clinical patients and communities. This information could be related to a specific disease or condition with the goal of assessing outcomes or building a data repository for sharing among experts. The information could also be at the population-level with the purpose of assisting with surveillance or screening in at-risk population.

What are the potential applications of a rare disease registry?

Registries can be of particular value to the rare disease community, whose patients are few and are widespread throughout the world. Registries offer a valuable opportunity for rare disease experts to maintain and share critical clinical data to support the development of treatments, advocacy measures, and networking. Registries also offer the opportunity to maintain patient information for recruitment into clinical trials, thus increasing the likelihood of achieving recruitment goals.

Navitas Clinical Research’s Support for Foundations

Foundations that focus on specific disease conditions play an integral role in the progress of research and development. Navitas Clinical Research has been actively supporting the needs of such Foundations in setting up registries, driving operational efficiency and building essential components that provide a competent ecosystem conducive for focus on research and development. We have worked with multiple Foundations, including U.S. Government funded the National Institute of Health (NIH).


Tell us more about yourself

I lead Navitas Clinical research and I bring decades of experience and a strong passion to assist Foundations in working with their patient populations to cope with their disease, deliver therapeutics and, ultimately, to find cures for multiple disease conditions.

I have held many senior roles in industry, services, and consulting businesses. I resonate with “NCR’s delivery excellence and deep subject matter expertise are exceptional. Coupled with a focus on the needs of Foundations, this ensures everybody wins – especially the Foundation and their patient population.”

What drives your passion to support disease registries for Foundations?

A personal sentiment that drives my passion has been watching and supporting the needs of my immediate family’s battle with Parkinson’s disease. I felt that I needed to do something to help in advancing care for patients,

Michael Garber,

Executive Director

Navitas Clinical Research

and I utilize my vast expertise in assisting Foundations improve operational efficiencies that could potentially slow progress in developing therapy for this relentless disease, and other debilitating disease conditions. Often, lack of operational efficiencies impedes critical scientific progress, hindering the management of the patient population or in securing donors.

Successful Registry and Data Coordinating Center Support for Parkinson’s Foundation’s Parkinson’s Disease GENEration Registry

Download the Case Study and learn how we

  • Streamlined process and support to over 90 sites
  • Provided efficient and effective data management and quality control
  • Ensured successful Integration of the clinical data of nearly 2000 patients with the genetic data
  • Shared data sets with The Global Parkinson’s Genetics Program (GP2), Institute on Aging (NIA) and Michael J Fox Foundation

How does Navitas Clinical research support Foundations?

Navitas Clinical Research’s aim is for Foundations to fully focus on developing suitable therapeutics for debilitating disease conditions, without being affected by operational inefficiencies. Navitas Clinical Research support Foundations by:

  • Alleviating data complexities, especially in patient trials
  • Supporting first-time right regulatory submissions
  • Providing robust, intuitive Registry and eSolutions offerings
  • Reducing operating costs by providing predictable outcomes in key support areas, e.g.

operational and regulatory support, Data Management, data analysis and visualization, privacy and information security. etc.

Live Webinar

Don’t Treat Your Registry Like It’s a Clinical Trial!

Date: Tuesday, 22nd March 2022 Time: 11:00 am - 12:00 am EST

Join Dr. Yun Lu, Vice President & Chief Science and Innovation Officer, Navitas Clinical Research and Sarah Lawrence, Sr. Clinical Project Manager, Navitas Clinical Research as they clearly elucidate the difference between a clinical trial and a patient registry.

During the webinar, they will also highlight the need for a robust strategy for patient registry and will outline the key considerations needed to achieve a comprehensive patient registry objective.

Don’t miss the Key insights from Mike Garber, Executive Director, Navitas Clinical Research.

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