USES OF PATIENTREGISTRIES FOR CLINICALSTUDIES TO ACQUIREUNWAVERING DATA

An Academic presentation byDr. Nancy Agnes, Head, Technical Operations, PepgraGroup:  www.pepgra.comEmail: pepgrahealthcare@gmail.com

In-Brief

Introduction

Patient Disease Registries

Patient Population

Time Elements

Core Data Elements

Today's Discussion

OUTLINE

Terminologies

Quality Management

Safety Analysis

Governance

Conclusion

In Brief

The patient registry is a specific study or a detailed survey of researchquestion or hypothesis generally. Clinical research statistical service is acollection of data from a particular population, the following details explain

about the patient registry and their methodological and operationalaspects. Pepgra strengthens your knowledge about the patient registries

in the medical field for the development of future clinical aspects andstudies in the clinical biostatistics and programming.

Introduction Patient registry is a coordinated system takes placeusing observational methods to acquire unwaveringdata on patient population based on the specificdisease, exposure and conditions. It follows the time.

The patient disease registries are created by publicorganizations, including educational institutions, medicalresearch association and clinical study design.

The overall objectives may vary such as to explain thenatural history of a disorder, to analyze the impacts ofdisease on patients health and routine life, to findpatients with an affinity for new treatments.

The registry also used for the evaluation of the safety ofmedicines and in the Clinical Biostatistics service.

PatientDiseaseRegistries

Patient population

Time elements

Core data elements

Terminologies

Quality management

Safety analysis

Governance

Our biostatistics consulting services consider theseessential factors to create and maintain a patient registrythey are.

PatientPopulation The patient population should be with more

excellent care, and various factors influencethe selection of the community.

It is vital to ensure comprehensiveenrolment of patients and bias selection withthe Clinical Biostatistics & StatisticalProgramming Service during thetherapeutics of clinical research.

Contd..

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.

The four essential steps to be carried out in our biostatistics programming services are.

TimeElements

The accurate follow up on date and time is essential inthe Biomedical research as it is the primary factor for thecomputation of period critical to the valid analysis ofdata includes time difference between registry entry andexposure to medicines, different treatment time and theonset of adverse events on a particular interest, recoveryfrom an adverse effect, effectiveness time, clinicalimprovement time etc.

Clinical Biostatistics Consulting Services have the timeelements that vary based on disease and variousfactors, but there are some major time elements shouldbe present in any registry are:

Contd..

Patient Dates include the date of birth, date of death, date of pregnancy, registryentry date, registry exit date, informed consent date

Disease Dates include the date of the first symptom, date of early diagnosis, dateof a definitive diagnosis, date of cure or improvement, date of relapse, date ofcomorbid 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 AESIresolution

Other Event Dates

Observation Dates include the date of follow up

Core DataElements

Core data elements are the harmonized data formon all patients the information of the same diseasein all registries should be identical to maintainstandard data quality system, data exchange, formaldata analysis for many patients and to compare theresults of different registries in the Statisticalprogramming CRO services.

Contd..

Patient dataDisease

Co-morbidities

Disease-related treatments

The most critical data elements for patient registries are

Contd..

Other therapies

Adverse effectsPregnancy

Terminologies

The data harmonization, it is essential tochange native languages to internationalterminologies, the guidelines for languages arefollowed based on the suggestion from EMA asper the clinical trial statistics service.

QualityManagement

Quality planningQuality assurance

Clinical research biostatistics services qualitymanagement involves four main activities they are:

Quality control

Quality improvement

Consistency

Completeness

There are four main requirements of data quality

Accuracy

Timeliness

SafetyAnalysis

Reporting of safety information

Monitoring of adverse effects of special interests

Aggregate analysis of adverse effects

Statistical programming CRO’s Safety analysisinvolves

Governance

Most registries have a governance modelrelying on principles and constraints based ontheir mandate operating procedure, legalenvironment or funding sources.

Registry coordinators, MAA/MAH andregulators, strengthen the use of registry data.

ConclusionPatient registry is an essential aspect of medicinalregulation as valuable data sources on diseaseand treatment.

In the pilot phase and specific disease-relatedworkshop, it is necessary to consider somefactors such as a recommendation from theregulators on the type of data, an acceptablelevel of quality and requirement regards safetyreporting guided by Pepgra.

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