Copyright © 2021 pepgra. All rights reserved 1

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

I. 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.

II. PATIENT DISEASE REGISTRIES

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

III. PATIENT POPULATION

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 2

and bias selection with the Clinical

Biostatistics & Statistical Programming

Service during the therapeutics of clinical

research.

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 a detailed data

IV. TIME 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

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 varies based on

disease and various factors but there are

some major time elements should be present

in any registry are:

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

V. 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

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

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.

Quality planning

Quality assurance

Quality control

Quality improvement

There are four main requirements of data

quality

Consistency

Completeness

Accuracy

Timeliness

VIII. 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

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. 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.

2. 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.

3. 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), 1495-

1500.