A patient registry is a clinical database that collects information about patients who are affected by a particular disease or exposed to a specific therapy.
Doctors and clinical investigators have been gathering and analyzing clinical data across multiple therapeutic areas for several decades for both research and patient care purposes.
- $What is an electronic patient registry?
- $Electronic patient registries and their use in cancer research
- $What clinical data is usually collected in an electronic patient registry?
- $Why are patient registries important for translational research?
- $Why are patient registries important for personalized medicine?
- $Patient registries and their value in rare disease research
- $Patient-centered clinical registries
- $Patient registries and real-world data (RWD)
- $What technological tools are there to implement an electronic patient registry?
- $What basic requirements should be met by electronic patient registries?
- $What patient registry software solution does Sofpromed offer?
Patient registries began with manual data extraction from patient records and all the work was performed in paper. However, health technology has evolved a lot, allowing interoperability and automatic transfers of information from electronic health records and patient data platforms (among other sources of clinical data).
Without doubt, patient registries play an essential role in health care systems by monitoring and informing the quality of medical care and generating new clinical knowledge that can lead to improved patient care.
For instance, cancer patient registries —which are implemented at regional, national, and international levels— contain highly relevant data for clinical and translational research in oncology.
These registries are typically created to gather clinical data on specific cancers in order to comprehend the progression of the disease and develop more effective treatments.
What is an electronic patient registry?
An electronic patient registry is a web-based software application used to collect uniform data of patients having a particular diagnosis or treatment.
Electronic patient registries are employed to keep track of patients affected by a specific disease, including data related to their medical history, diagnosis, treatments, and other health-related information.
These registries can be used to improve patient management in daily medical practice, but they are also useful for clinical research projects.
Doctors may create electronic patient registries using a spreadsheet program, such as Microsoft Excel, or a database program, such as Microsoft Access.
Nevertheless, even though these basic tools can be useful to manage a rather small number of patients at local level, more powerful systems are normally required to carry out larger national or international studies.
Electronic patient registries and their use in cancer research
Electronic patient registries are widely used in clinical studies across multiple diseases, being oncology one of the main areas of research.
Electronic cancer registries are extremely beneficial for clinical research since they offer clinical data that improves the understanding of the course of various cancer types.
For example, a registry of cancer patients allows to collect the date of the initial diagnosis and the date of metastasis.
At the same time, the date of treatment initiation and the date of tumor progression (worsening) to this treatment can be used to assess the progression-free survival of a patient with respect to certain antitumor drugs.
On the other hand, cancer registries collect long-term follow-up dates of patients, recording the dates of death caused by the tumor they suffer.
This information is essential to evaluate the efficacy of antineoplastic drugs and estimate the life expectancy of patients with different types of malignancies.
Oncologists also use electronic patient registries for the following goals:
- Engaging cancer patients by obtaining their perspective, opinions, and experiences (e.g., quality of life as patient reported outcome)
- Recruiting patients for clinical trials
- Studying natural history data, which involves understanding tumor progression
- Implementing national registries to know what population is affected by a specific cancer
What clinical data is usually collected in an electronic patient registry?
Electronic patient registries store many types of clinical data depending on the disease under investigation.
For instance, in oncology, although each tumor registry is designed differently, depending on the type of cancer under study, the following information is frequently analyzed:
- Medical history
- Diagnosis data (biopsy dates, molecular tests)
- Tumor status (localized, locally advanced, metastatic disease)
- Systemic treatments received (chemotherapies, targeted therapies)
- Surgeries and radiotherapies
- Radiological responses to the different treatments (stabilization, partial response, complete response, progression)
- Dates of tumor progression
- Dates of death
Why are patient registries important for translational research?
In cancer research, registries contain clinical data that can be correlated with biological or molecular information from patients.
This research that attempts to correlate clinical results with molecular findings is known as “translational research” and involves the participation of molecular biologists.
The “translational” concept is based on transferring the results and knowledge discovered in the basic research laboratory to the clinic, so that they have an impact on clinical practice.
For example, in oncology, clinical data from patients (efficacy data such as radiological response and survival) may be correlated with molecular data obtained from tumor and blood samples.
This type of research allows to predict that some patients with certain biological or genetic characteristics may benefit more from certain drugs.
Why are patient registries important for personalized medicine?
The clinical data contained in electronic registries is also highly relevant for personalized medicine.
Personalized medicine aims to improve the management of a patient’s health and to target therapies to achieve the best outcomes for patients with specific features.
Based on translational research, being able to correlate the biological characteristics of patients with clinical results allows the development of more personalized treatments.
In other words, the objective is to develop more effective therapies based on the particular characteristics of each patient.
Patient registries and their value in rare disease research
In recent years we have witnessed an increased interest in the investigation of rare diseases.
Understanding the natural history of a rare disease is critical for the development of new medicinal products.
This includes information on the incidence, prevalence, outcomes of the disease and characteristics of the patient population.
However, the knowledge on rare diseases is limited for several reasons, such as small patient populations, spread over a broad area, restricted funding to support research, the complexity of the disease, and delayed diagnosis, among others.
Electronic registries with international coverage can be very cost-effective tools to collect rare disease data and enable multinational collaboration among clinical research groups located in various countries.
Patient-centered clinical registries
The use of electronic registries is expanding together with the relevance of patient-centered care. This means that the perspective and feedback from a larger set of actors are being required, including patients and their families.
Patients, relatives, and caregivers are now playing a vital role in helping to identify and prioritize aspects of care that are important to them.
With the growing emphasis on patient-centered care and the acknowledgment that the patient voice is essential to achieving better outcomes, patient engagement in clinical registries has become a crucial element.
Patient registries and real-world data (RWD)
The evolution of patient registries in the last few years has been closely connected with the concept of real-world data (RWD).
The current trend towards patient-centered healthcare is enabling patient registries to increasingly emerge as a valuable tool for generating insights from the collected data.
In fact, in the last few years, the Food and Drug Administration (FDA) of the United States, the European Medicines Agency (EMA) and other regulatory bodies have launched several initiatives to highlight the importance of patient registries.
For example, patient registries are used to determine the effectiveness of investigational products by exploring various subgroup of patients.
Registries are also useful to evaluate the long-term safety of an approved drug and identify areas of improvement of real-world clinical practices.
What technological tools are there to implement an electronic patient registry?
One of the key ingredients for the success of an electronic registry is having a solid technological tool to implement it.
Electronic registries are usually built by using a web-based software platform called an electronic case report form (eCRF).
This platform is a web application that allows medical staff located at clinical sites to enter data in a common electronic record, making the data immediately available to the team in charge of the analysis.
The sponsors of clinical studies must assess which software applications are the most suitable for the particularities of their research project.
What basic requirements should be met by electronic patient registries?
When selecting a registry software, users must ensure that the application they are going to use meets these essential requirements:
- Access control: The platform must have an access control mechanism that oversees the users who connect to the system. This module must generate a historical record of the users who had access to the platform.
- Traceability: User activity within the platform must be recorded in a traceable log. This log must record what values have been inserted in each of the forms, including the modifications of these values.
- Backups: Every patient registry system should have a reliable backup mechanism, to restore data in the event of a serious technical incident or disaster.
What patient registry software solution does Sofpromed offer?
Sofpromed is a clinical research organization (CRO) specialized in providing web applications for the implementation of electronic patient registries.
Our patient registry software is used to carry out observational studies in multiple therapeutic areas, at both national and international levels, always meeting the quality and safety standards required by regulatory agencies.
Sofpromed’s web-based registry tools can also be utilized for patient care purposes in the daily medical practice, being an ideal solution for medical departments and independent physicians.