Four strategies to upgrade clinical trial quality in this computerized world – Pubrica
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Transcript of Four strategies to upgrade clinical trial quality in this computerized world – Pubrica
Copyright © 2021 pubrica. All rights reserved 1
Four Strategies to Upgrade Clinical Trial Quality in this Computerized World
Dr. Nancy Agnes, Head,
Technical Operations, Pubrica
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
Copyright © 2021 pubrica. All rights reserved 2
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.
Copyright © 2021 pubrica. All rights reserved 2
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
Copyright © 2021 pubrica. All rights reserved 2
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].