Four strategies to upgrade clinical trial quality in this computerized world – Pubrica

1. FOUR STRATEGIES TO UPGRADE CLINICAL TRIAL QUALITY IN THIS COMPUTERIZEDWORLD An Academic presentationby Dr.NancyAgnes,Head,TechnicalOperations,Pubrica Group: www.pubrica.com Email:sales@pubrica.com

2. Today'sDiscussion Outline In-Brief Introduction BiostatisticsServices Clinical TrialQuality ConceptofQualityinClinicalTrial FourStrategiestoUpgradeClinicalTrialQuality Conclusion

3. In-Brief BiostatisticsServicesis 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 clinicalresearch.

4. Introduction The global pharmaceutical industry has been facing problems in recent years, with costinflation and drug growthdelays. The twin objectives of biostatistics consulting services– saving of expense and time –have culminated in the globalization of clinical trialsto developedcountries. Contd...

5. The differences between developed and developing countries in regulatorysystems, ethical concerns, medical skills, clinical practice and health facilities make the third goal challenging and demanding: conformity with globalquality. Globalization and outsourcing of clinical trials have completed it challengingand tough to attain globalconsistency.

6. 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.

7. Clinical Trial Quality Biostatistical Services offers quality that can be characterized as the absence of errors that matter in clinicaltrials. The prosecution's quality essentially depends ona well-articulated forensic strategy (e.g., protocol, analysis and managementplans). Clearly defined goals and related resultmetrics should be included in thetrial.

8. Concept of Quality in ClinicalTrial Biostatistics for clinical researchhave universal ethics, and scientific professional criterion forclinical trials' execution is Good Clinical Practice(GCP). The GCP norm extends to all facets of theclinical trialprocess. The standard is a spectrum under the GCP guidance, which starts with designing, is crucial during conducting and documenting, andcontinues during trialreporting. Contd...

9. A lack of protocol consistency or a case record type (CRF) will alsoincrease reporting observations and dataqueries. 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 risksof a medical product (therapeutic or diagnostic) orprocedure.

10. Four Strategiesto 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. Contd...

11. 1)DESIGN PRINCIPLES: Minimizingvariation: The higher the difference, the harder it is to trackmedication results. Minimizing heterogeneity is, therefore, a central aspect of the nature of clinicaltrials. An end-point, for example, maybe the diagnosis of neuropathy ordementia. These evaluations, however, are partially arbitrary. Biostatistics consulting firms get the result with simple descriptions, and consistent assessments, heterogeneity in these diagnoses can bereduced. Contd...

12. Randomizationandstratification: Randomization is a powerful instrumentthat allows in clinical trials to controlbias. It effectively removes the stigma involved with the selection ofmedication. Biostatistics in clinical trials equilibrium expectation given by randomizationand the ITT principle provide the basis for statisticalinference. Blinding: Blinding is an essential tool in the design of clinical trials and aneffective mechanism for bias prevention andreduction. Contd...

13. Blinding refers to holding study participants, researchers, or assessors unawareof the interventionassigned. They may be less likely to have biased psychological or physical reactionsto intervention when study participants areblinded. 2)DATA QUALITY AND QUANTITY (INCLUDESMONITORING): Subject Review: The subsequent key displays, as applicable, should be revised on an ongoing foundation by an experienced person other than the personentering theinformation: Contd...

14. Informed Consent, AssentProcess EligibilityCriteria Concomitant/ProhibitedMedications AE/SAE and UPReporting Investigational ProductAdministration 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 orquarterly) reports summarizing quality reviewsresults. Contd...

15. The entire research team should share these reports withthem. 3)STUDY STARTUP: Selectingcountries and sites: As most clinical trialsare global and theselectionof sites is multi-factorial when discussing sites' selection, this means the evaluation and selection process for prospective investigators' clinicalstudy. Of course, CROs and sponsors are looking to get the most qualified and correctsites and researchers, which generate rivalry betweenthem. Contd...

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17. Improving startup: A common mistake is to rely on too little data orpersonal information when making decisions about a country's involvement, sites forstudy conduct or recruitmentstrategies. It includes country and site selection based on personalpreferences. 4)ADVERSE EVENT REPORTING: Any unfavourable or unintentional symptom or indication momentarily associated with an investigational intervention during the conduct of a clinical trial, includinga shift in laboratoryresults. Contd...

18. Whether this incident is considered related or unrelated to this action doesnot 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 incidentsreported to the sponsor in duetime. Raw Data: To mitigate the risk of having studied with under-reporting in ourdata set, we used only data from completed and terminated clinical trials, whereAE reconciliation had been performed as part of the study closureactivities. Contd...

19. FeaturesandTargets: To construct features, we needed to project alldata attributes to the visitlevel. For demographic characteristics that were constant, such as sex and ethnicity,or had a direct dependence on the date, such as age, this wasstraightforward. For medical history, we counted the events that occurred before everyvisit.

20. Conclusion TherolesandresponsibilitiesofStatistics Programming Servicesareoverlapping. All disciplines have distinct focuses,however. Clinical research, systematic reviews, andthe working climate are complex and multidisciplinary in biostatisticalactivities. Contd...

21. Therefore, biostatistics Support Service is essential for fruitful, efficient, and high-quality collaborations to clearly define theresponsibilities. For which the ICH E6 guidance similarly formulates the tasks by concerninggood clinicalpractice.

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