pepgra

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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_at_gmai
l.com
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Today's Discussion

• OUTLINE
• In-Brief Introduction
• Patient Disease Registries Patient Population
• Time Elements
• Core Data Elements

Terminologies Quality Management Safety
Analysis Governance Conclusion
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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 c linical biostatistics and
programming.
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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 c linical 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 C linical Biostatistics
service.
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Patient Disease Registries
Our b iostatistics 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
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Patient Population
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 c linical research.
Contd..
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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.
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Time Elements
The accurate follow up on date and time is
essential in the B iomedical 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..
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P atient Dates include the date of birth, date of
death, date of pregnancy, registry entry date,
registry exit date, informed consent
date D isease 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 I nvestigation Dates include the
date of test 1, test2, test 3 T reatment Dates
include start date, stop date
Contd..
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A ESI Dates include the date of any
AESI occurrence, date of any AESI
resolution O ther Event Dates O bservation
Dates include the date of follow up
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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 S tatistical programming CRO
services.
Contd..
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The most critical data elements for patient
registries are
Other therapies Adverse effects Pregnancy
P atient data Disease Co-morbidities Disease-rela
ted treatments
Contd..
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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 c linical trial statistics service.

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Quality Management
Clinical research biostatistics services
quality management involves four main activities
they are
Quality control Quality improvement
Quality planning Quality assurance
There are four main requirements of data quality
Consistency Completeness
Accuracy Timeliness
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Safety Analysis
Statistical programming CROs Safety
analysis involves Reporting of safety
information Monitoring of adverse effects of
special interests Aggregate analysis of adverse
effects
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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.
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Conclusion

• Patient registry is an essential aspect of m
  edicinal r egulation 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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