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A Guide to Phase 1 Clinical Trial Designs

Statistical Consultancy Team

The primary aims of Phase 1 Clinical Trials are to determine the safety, tolerability and pharmacokinetics (PK) of a compound. Trials have historically been conducted in the logical sequence of single ascending dose, multiple ascending dose, examination of preliminary effect of food on exposure, and potential drug-drug interaction, with assessments to determine the effect of gender, age, bioavailability and bioequivalence performed as necessary.

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Topics: Pharmacokinetics and Pharmacodynamic, Phase I Studies, Phase I Study Design, Clinical Trial Phases, Bioequivalence, Drug-drug Interaction, Bioavailability, Phase 3 Studies, Peadiatric Assessments

Statistical Methods in Risk Based Monitoring

Statistical Consultancy Team

This blog explores the statistical methods used in Risk Based Monitoring (RBM) and how the result of such statistical methods enables improved data integrity across a clinical trial.

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Topics: Statistical Consultancy, Laboratory Datasets, ICHGCP E6, Risk Based Monitoring, Statistics, Centralized Monitoring

Remote Monitoring During Clinical Trials, a Risk Based Approach

Medical Writing Team

Within the last few decades the number and complexity of clinical trials has increased considerably, not only across the industry but within individual companies.  With this increase comes the enhanced pressure of effectively monitoring these trials. 

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Topics: Regulatory Requirements, Clinical Trials, Good Clinical Practice (GCP), Clinical Data Storage, Case Report Form (CRF), Remote Monitoring, Adverse Events (AEs), Ethics, On-Site Monitoring, Risk Based Monitoring, Centralized Monitoring

[Published Journal] Using Observational Studies to Investigate the Relationship Between Fatigue and Work Disability

Statistical Consultancy Team

Our Statistical Consultancy Team recently collaborated on a study to investigate the long-term relationship between fatigue and work disability in patients initiating treatment with etanercept for rheumatoid arthritis (RA) or ankylosing spondylitis (AS); and this work has now been published. (https://arthritis-research.biomedcentral.com/articles/10.1186/s13075-018-1598-8)

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Topics: Statistical Consultancy, Observation Longitudinal Database, Observational Studies, Inflammatory Rheumatic Diseases, Rheumatoid Arthritis (RA)

Why do a 3rd of Submissions fail the Technical Rejection Criteria?

Clinical Programming Team

At the July 25th PhUSE Webinar Wednesday, Ethan Chen (Director, Division of Data Management Services and Solutions Office of Business Informatics, FDA CDER) gave us a glimpse of the FDA’s view on Technical Rejection Criteria for Study Data. Those that were at the US Connect Conference earlier in the year may have seen this already.

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Topics: Define.xml, ADaM Datasets, CDISC Standards, SDTM, SAS Programming, FDA, CDISC, SDTM Domains, CDISC SDTM, CDISC Guidelines

Nutraceutical trials: demand, design and challenges

Statistical Consultancy Team

Food ingredient and nutraceutical manufacturers are increasingly looking to market their products by substantiating their unique health benefits.

There are many generic, widely used claims - in the EU, Article 13.1 of the European Food Safety Authority’s (EFSA) EC Regulation permits manufacturers to use some 4,6371 that pertain to vitamin and mineral content.

This proliferation is driving manufacturers to develop unique claims to use in marketing efforts, which in turn has led to a significant growth in demand for nutraceutical trials.

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Topics: Nutraceutical Trials, Biostatistics Consulting, Statistics, Clinical Study Design, Regulatory Requirements

Bayesian approaches to use historical data in the analysis of clinical trials

Statistical Consultancy Team

The BAYES 2018 Bayesian Biostatistics workshop took place from the 20th to the 22nd of June, and was an extraordinary chance to discuss how Bayesian methodology can be used within the pharma industry.

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Topics: Bayesian Study Design, Bayesian Methods, Bayesian Statistics, Historical Data, Statistical Consultancy, Statistics, Biostatistics Consulting, Clinical Study Design

[Video] Bayesian Methodology - How to Analyse Multiple Endpoints

Statistical Consultancy Team

In this Statistical Knowledge Share Video our Principal Statisticians, Sonia, presents an example of Bayesian Methodology using simulated data and examines how to analyze Multiple End Points in Clinical Trials.

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Topics: Statistics, Statistical Knowledge Share, Multiple Endpoints, Bayesian Methods, Bayesian Statistics, SAS Programming

First Steps in Laboratory Dataset in SAS

Clinical Programming Team

The laboratory dataset is one of the core safety datasets and, at first glance, it could appear intimidating, with multiple tests and visits per patient. This article will illustrate checks that are worth applying at the very beginning of programming work – these could be in addition to the standardized process of domain validation.

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Topics: Laboratory Datasets, Safety Dataset, Statistical Programming, SAS Programming, SAS, Clinical Programming, CDISC Standards, CDISC SDTM, SAS Macros, SAS Datasets, SDTM, Case Report Form (CRF), SDTM Domains, CDISC Guidelines, CDISC

Implementing Electronic Data Capture (EDC) systems in Clinical Trials

Clinical Data Management Team

Clinical Trial Management Systems (CTMS) are an important part of every clinical trial. Selecting the right CTMS helps address inefficiencies on the operational side of research, such as clinical trial planning, preparation, performance and reporting. As more and more pharma and biopharma sponsors start to recognize the potential opportunities that exist with EDC-CTMS integration, there is a growing need to address the complex process of electronic data capture (EDC) implementation.

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Topics: Clinical Data Management, Electronic Data Capture, Paper-Based Studies, eCRF, Case Report Form (CRF), CDISC, CDISC CDASH, Outsourcing Solutions

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