USES OF PATIENT
REGISTRIES FOR CLINICAL
STUDIES TO ACQUIRE
UNWAVERING DATA
An Academic presentation by
Dr. Nancy Agnes, Head, Technical Operations, Pepgra
Group: www.pepgra.com
Email: pepgrahealthcare@gmail.com
Today's Discussion
OUTLINE
In-Brief
Terminologies
Introduction
Quality Management
Patient Disease Registries
Safety Analysis
Patient Population
Governance
Time Elements
Conclusion
Core Data Elements
In Brief
The patient registry is a specific study or a detailed survey of research
question or hypothesis generally. C linical research statistical service is a
collection of data from a particular population, the following details explain
about the patient registry and their methodological and operational
aspects. Pepgra strengthens your knowledge about the patient registries
in the medical field for the development of future clinical aspects and
studies in the clinical biostatistics and programming.
Introduction
Patient registry is a coordinated system takes place
using observational methods to acquire unwavering
data on patient population based on the specific
disease, exposure and conditions. It follows the time.
The patient disease registries are created by public
organizations, including educational institutions, medical
research association and clinical study design.
The overall objectives may vary such as to explain the
natural history of a disorder, to analyze the impacts of
disease on patients health and routine life, to find
patients with an affinity for new treatments.
The registry also used for the evaluation of the safety of
medicines and in the Clinical Biostatistics service.
Patient
Disease
Regist ries
Our biostatistics consulting services consider these
essential factors to create and maintain a patient registry
they are.
Patient population
Time elements
Core data elements
Terminologies
Quality management
Safety analysis
Governance
Patient
Populat ion
The patient population should be with more
excellent care, and various factors influence
the selection of the community.
It is vital to ensure comprehensive
enrolment of patients and bias selection with
the Clinical Biostatistics & Statistical
Programming Service during the
therapeutics of clinical research.
Contd..
The four essential steps to be carried out in our biostatistics programming services are.
To create a logical definition on selected population.
Convert logical description into the operational definition.
Make a process in which enrolled patients should represent the working definition.
Complete follow up on each patient to gather detailed data.
Time
Element s
The accurate follow up on date and time is essential in
the Biomedical research as it is the primary factor for the
computation of period critical to the valid analysis of
data includes time difference between registry entry and
exposure to medicines, different treatment time and the
onset of adverse events on a particular interest, recovery
from an adverse effect, effectiveness time, clinical
improvement time etc.
Clinical Biostatistics Consulting Services have the time
elements that vary based on disease and various
factors, but there are some major time elements should
be present in any registry are:
Contd..
Patient Dates include the date of birth, date of death, date of pregnancy, registry
entry date, registry exit date, informed consent date
Disease Dates include the date of the first symptom, date of early diagnosis, date
of a definitive diagnosis, date of cure or improvement, date of relapse, date of
comorbid events occurrence, date of the resolution of comorbid events
Investigation Dates include the date of test 1, test2, test 3
Treatment Dates include start date, stop date
Contd..
AESI Dates include the date of any AESI occurrence, date of any AESI
resolution
Other Event Dates
Observation Dates include the date of follow up
Core Data
Elements
Core data elements are the harmonized data form
on all patients the information of the same disease
in all registries should be identical to maintain
standard data quality system, data exchange, formal
data analysis for many patients and to compare the
results of different registries in the Statistical
programming CRO services.
Contd..
The most critical data elements for patient registries are
Patient data
Other therapies
Disease
Adverse effects
Co-morbidities
Pregnancy
Disease-related treatments
Contd..
Terminologies
The data harmonization, it is essential to
change native languages to international
terminologies, the guidelines for languages are
followed based on the suggestion from EMA as
per the clinical trial statistics service.
Quality
M anagement
Clinical research biostatistics services quality
management involves four main activities they are:
Quality planning
Quality control
Quality assurance
Quality improvement
There are four main requirements of data quality
Consistency
Accuracy
Completeness
Timeliness
Safety
Analysis
Statistical programming CRO’s Safety analysis
involves
Reporting of safety information
Monitoring of adverse effects of special interests
Aggregate analysis of adverse effects
Governance
Most registries have a governance model
relying on principles and constraints based on
their mandate operating procedure, legal
environment or funding sources.
Registry coordinators, MAA/MAH and
regulators, strengthen the use of registry data.
Conclusion
Patient registry is an essential aspect of m
edicinal
regulation as valuable data sources on disease
and treatment.
In the pilot phase and specific disease-related
workshop, it is necessary to consider some
factors such as a recommendation from the
regulators on the type of data, an acceptable
level of quality and requirement regards safety
reporting guided by Pepgra.
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