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Four Strategies to Upgrade Clinical Trial Quality in this Computerized World

Dr. Nancy Agnes, Head,

Technical Operations, Pubrica

sales@pubrica.com

In-Brief

Biostatistics Services is important for

collecting, reviewing, presenting, and

interpreting data in clinical research.

Applications of clinical biostatistics

services are in different areas, such as

epidemiology, clinical trials, population

genetics, the biology of structures, and

more. It helps make decisions about the

effectiveness and safety of a medication,

line of care, or therapy in clinical research.

Keywords: Biostatistics Services, clinical

biostatistics services, biostatistics

consulting services, biostatistics CRO,

Statistical Programming Services,

Biostatistical Services, biostatistics

consulting firms, Biostatistics for clinical

research, statistics in clinical trials,

biostatistics in clinical trials, Biostatistics

Support Service.

I. INTRODUCTION

The global pharmaceutical industry has been

facing problems in recent years, with cost

inflation and drug growth delays. The twin

objectives of biostatistics consulting

services– saving of expense and time – have

culminated in the globalization of clinical

trials to developed countries. The

differences between developed and

developing countries in regulatory systems,

ethical concerns, medical skills, clinical

practice and health facilities make the third

goal challenging and demanding: conformity

with global quality. Globalization and

outsourcing of clinical trials have completed

it challenging and tough to attain global

consistency.

II. BIOSTATISTICS SERVICES

Biostatistics CRO is a science branch that

focuses on creating and applying statistical

techniques to address health-related issues

such as medicine, epidemiology, and public

health.

III. CLINICAL TRIAL QUALITY

Biostatistical Services offers quality that can

be characterized as the absence of errors that

matter in clinical trials. The prosecution's

quality essentially depends on a well-

articulated forensic strategy (e.g., protocol,

analysis and management plans). Clearly

defined goals and related result metrics

should be included in the trial.

IV. CONCEPT OF QUALITY IN

CLINICAL TRIAL

Biostatistics for clinical research have

universal ethics, and scientific professional

criterion for clinical trials' execution is Good

Clinical Practice (GCP). The GCP norm

extends to all facets of the clinical trial

process. The standard is a spectrum under

the GCP guidance, which starts with

designing, is crucial during conducting and

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documenting, and continues during trial

reporting. A lack of protocol consistency or

a case record type (CRF) will also increase

reporting observations and data queries.

Including the notions of benefit, GCP

definition of consistency has been updated:

the possibility of a new medical organization

(NME). Quality is defined by the Clinical

Trials Transformation Initiative (CTTI) as

the ability to react adequately to the

expected question about the advantages and

risks of a medical product (therapeutic or

diagnostic) or procedure.

V. FOUR STRATEGIES TO UPGRADE

CLINICAL TRIAL QUALITY

The CTTI has launched several programs to

identify activities that can improve clinical

trials' consistency and reliability. Statistics

in clinical trials have four research focus

areas: Designed principles, data quality and

quantity (including monitoring), study

startup and adverse event reporting.

1) Design principles:

Minimizing variation: The higher the

difference, the harder it is to track

medication results. Minimizing

heterogeneity is, therefore, a central

aspect of the nature of clinical trials. An

end-point, for example, maybe the

diagnosis of neuropathy or dementia.

These evaluations, however, are partially

arbitrary. Biostatistics consulting firms

get the result with simple descriptions,

and consistent assessments,

heterogeneity in these diagnoses can be

reduced.

Randomization and stratification:

Randomization is a powerful instrument

that allows in clinical trials to control

bias. It effectively removes the stigma

involved with the selection of

medication. Biostatistics in clinical trials

equilibrium expectation given by

randomization and the ITT principle

provide the basis for statistical inference.

Blinding: Blinding is an essential tool in

the design of clinical trials and an

effective mechanism for bias prevention

and reduction. Blinding refers to holding

study participants, researchers, or

assessors unaware of the intervention

assigned. They may be less likely to

have biased psychological or physical

reactions to intervention when study

participants are blinded.

2) Data quality and quantity (includes

monitoring):

Subject Review: The subsequent key

displays, as applicable, should be revised

on an ongoing foundation by an

experienced person other than the person

entering the information:

i. Informed Consent, Assent Process

ii. Eligibility Criteria

iii. Concomitant/Prohibited Medications

iv. AE/SAE and UP Reporting

v. Investigational Product

Administration

Binder Quality Review: A quality review

of necessary forms would contain all

documents registered in the International

Conference on Harmonisation (ICH),

and Guidelines for Good Clinical

Practice (GCP).

Reporting Results: It is essential to

prepare periodically (e.g. monthly or

quarterly) reports summarizing quality

reviews results. The entire research team

should share these reports with them.

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3) Study startup:

Selecting countries and sites: As most

clinical trials are global and the selection

of sites is multi-factorial when

discussing sites' selection, this means the

evaluation and selection process for

prospective investigators' clinical study.

Of course, CROs and sponsors are

looking to get the most qualified and

correct sites and researchers, which

generate rivalry between them.

Improving startup: A common mistake is

to rely on too little data or personal

information when making decisions

about a country's involvement, sites for

study conduct or recruitment strategies.

It includes country and site selection

based on personal preferences.

4) Adverse event reporting :

Any unfavourable or unintentional symptom

or indication momentarily associated with an

investigational intervention during the

conduct of a clinical trial, including a shift in

laboratory results. Whether this incident is

considered related or unrelated to this action

does not matter.

Outline and assumptions: The purpose of

this attempt at proof-of-concept (PoC)

was to develop and test a predictive

model's output that can help diagnose

AE under-reporting. Here may be a

fundamental link between the drug

intake and the incidents reported to the

sponsor in due time.

Raw Data: To mitigate the risk of having

studied with under-reporting in our data

set, we used only data from completed

and terminated clinical trials, where AE

reconciliation had been performed as

part of the study closure activities.

Features and targets: To construct

features, we needed to project all data

attributes to the visit level. For

demographic characteristics that were

constant, such as sex and ethnicity, or

had a direct dependence on the date,

such as age, this was straightforward.

For medical history, we counted the

events that occurred before every visit.

VI. CONCLUSION

The roles and responsibilities of Statistical

Programming Services are overlapping. All

disciplines have distinct focuses, however.

Clinical research, systematic reviews, and

the working climate are complex and

multidisciplinary in biostatistical activities.

Therefore, biostatistics Support Service is

essential for fruitful, efficient, and high-

quality collaborations to clearly define the

responsibilities. For which the ICH E6

guidance similarly formulates the tasks by

concerning good clinical practice.

REFERENCES

1. Institute of Medicine Assuring data quality and

validity in clinical trials for regulatory decision

making: workshop report Accessed December 21

2010

2. Clinical Trials Transformation Initiative. [last

accessed on 2011 May 2]. Available from: http: /

/www.trialstransformation.org

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3. Kleppinger CF, Ball LK. Building Quality in clinical

trials with the use of a quality systems approach. Clin

Infect Dis. 2010;51(Suppl 1):S111–6.

4. Meeker-O'Connell A. Enhancing clinical trial quality:

CDER perspective. [Last accessed on 2011 May 2].