Four strategies to upgrade clinical trial quality in this computerized world - Pubrica
                     FOUR STRATEGIES TO  
UPGRADE CLINICAL  
TRIAL QUALITY IN THIS  
COMPUTERIZED 
WORLD
An Academic presentation by
Dr. Nancy Agnes, Head, Technical Operations, 
Pubrica  Group: www.pubrica.com
Email: [email protected]
Today's Discussion
Outlin
In-Brief  
e
Introductio
n
Biostatistics Services 
 Clinical Trial Quality
Concept of Quality 
in Clinical Trial
Four Strategies to Upgrade Clinical Trial 
Quality  Conclusion
In-Brief
B  iostatistics 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.
Introduction
The global pharmaceutical industry has been  
facing problems in recent years, with cost 
inflation  and drug growth delays.
The twin objectives of b iostatistics consultin
g   s ervices– saving of expense and time – 
have
culminated in the globalization of clinical trials to 
 developed countries.
Contd...
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.
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.
Clinical 
 Trial  Biostatistical Services offers quality that can be  
Quality 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.
Concept of  
Quality in  Biostatistics for clinical research have universal  
ethics, and scientific professional criterion for clinical 
Clinical Trial  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 documenting, and continues 
 during trial reporting.
Contd...
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.
Four  
Strategies to 
 Upgrade  The CTTI has launched several programs to 
 identify activities that can improve clinical  
Clinical Trial  trials' consistency and reliability.
Quality
Statistics in clinical trials have four research  
focus areas: Designed principles, data quality 
 and quantity (including monitoring), study  
startup and adverse event reporting.
Contd.
..
1) DESIGN PRINCIPLES:
M inimizing 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.
Contd...
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.
Contd...
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):
S ubject 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:
Contd...
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.
Contd...
The entire research team should share these reports with them.
3) STUDY STARTUP:
S electing countries and sites: As most c linical 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.
Contd...
Contd...
I mproving 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.
Contd...
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.
Contd...
F eatures 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.
Conclusio
n The roles and responsibilities of  
Statistics  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.
Contd...
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.
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