Uses of Patient Registries for Clinical Studies to Acquire Unwavering Data
Dr. Nancy Agnes, Head,
Technical Operations, Pepgra
Sales.cro@pepgra.com
In-Brief
The patient registry is a specific study or a
detailed survey of research question or
hypothesis generally. Clinical research
statistical service is a collection of data
from a particular population; the following
details explain the patient registry and their
methodological and operational aspects.
Pepgra strengthens your knowledge about
the patient registries in the medical field to
develop future clinical aspects and studies
in
the
clinical
biostatistics
and
programming.
Keywords:
Clinical Biostatistics services, biostatistics
consulting services, Clinical Biostatistics &
Statistical Programming Service, Statistical
programming
services,
Clinical
Biostatistics Consulting Services, clinical
trial
statistics
service,
statistical
programming
cro,
biostatistics
programming services, clinical biostatistics
and programming, clinical research
statistical services, clinical research
biostatistics services, biostatistics services
for clinical research
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.
II. PATIENT DISEASE REGISTRIES
Our biostatistics consulting services
consider these essential factors to create and
maintain a patient registry they are.
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Patient population
Time elements
Core data elements
Terminologies
Quality management
Safety analysis
Governance
I. INTRODUCTION
III. PATIENT POPULATION
Patient registry is a coordinated system takes
place using observational methods to
acquire unwavering data on patient
The patient population should be with more
excellent care, and various factors influence
the selection of community. It is vital to
ensure comprehensive enrolment of patients
Copyright © 2021 pepgra. All rights reserved
1
and bias selection with the Clinical
Biostatistics & Statistical Programming
Service during the therapeutics of clinical
research.
treatment time and the onset of adverse
events on a particular interest, recovery from
an adverse effect, effectiveness time, clinical
improvement time etc.
The four essential steps to be carried out in
our biostatistics programming services are.
Clinical Biostatistics Consulting Services
have the time elements that varies based on
disease and various factors but there are
some major time elements should be present
in any registry are:
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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 a detailed data
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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
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
IV. TIME ELEMENTS
V. CORE DATA ELEMENTS
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
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
Copyright © 2021 pepgra. All rights reserved
2
of different registries in the Statistical
programming CRO services.
The most critical data elements for patient
registries are
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Patient data
Disease
Co-morbidities
Disease-related treatments
Other therapies
Adverse effects
Pregnancy
VI. 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.
VII. QUALITY MANAGEMENT
Clinical research biostatistics services
quality management involves four main
activities they are.
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Quality planning
Quality assurance
Quality control
Quality improvement
There are four main requirements of data
quality
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Consistency
Completeness
Accuracy
Timeliness
Copyright © 2021 pepgra. All rights reserved
VIII. SAFETY ANALYSIS
Statistical programming
analysis involves
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CRO’s
Safety
Reporting of safety information
Monitoring of adverse effects of
special interests
Aggregate analysis of adverse effects
IX. 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
X. CONCLUSION
Patient registry is an essential aspect of
medicinal 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.
REFERENCES
1.
2.
3.
McGettigan, P., Olmo, C. A., Plueschke, K., Castillon, M.,
Zondag, D. N., Bahri, P., ... & Mol, P. G. (2019). Patient
Registries: An Underused Resource for Medicines
Evaluation. Drug safety, 42(11), 1343-1351.
Culver, D. A., Behr, J., Belperio, J. A., Corte, T. J., de
Andrade, J. A., Flaherty, K. R., ... & Ryerson, C. J. (2019).
Patient registries in idiopathic pulmonary fibrosis. American
journal of respiratory and critical care medicine, 200(2),
160-167.
Rice, H. E., Englum, B. R., Gulack, B. C., Adibe, O. O.,
Tracy, E. T., Kreissman, S. G., & Routh, J. C. (2015). Use of
patient registries and administrative datasets for the study of
pediatric cancer. Pediatric blood & cancer, 62(9), 14951500.
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