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Should We Be Integrating Mobile Health Apps in Clinical Trials?

Statistical Consultancy Team

Wearables and mobile health (Mhealth) apps collect subject/patient data from mobile or purpose built devices to record data in real time. The rationale behind this type of technology is to reduce the burden on subjects by eliminating unnecessary procedures, streamlining routine procedures and reducing time spent at clinical trial sites. It is evident from the review of a range of literature that studies integrating some form of mobile health technology can be broadly categorised into a few phases of development: studies on the development of new devices, studies on the validity of functional wearable devices, studies comparing new device and conventional endpoints, and finally those studies which trial the device as a health intervention. This article aims to briefly discuss these phases with reference to examples of recent studies demonstrating some safety or efficacy endpoint relating to a newly developed device.

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Topics: Clinical Trials, Clinical Study Design, Biostatistics Consulting, Technology Trends, Wearables in Clinical Trials, Wearables, mHealth

Integrated Summaries of Safety & Efficacy for Regulatory Submissions

Statistical Consultancy Team

Far from being simply a summary of individual results, a comprehensive and detailed summary allows companies to make informed decisions. Producing comprehensive integrated summaries of safety and efficacy is a critical stage of the submission life cycle. These need to be designed and planned carefully in advance to ensure informed decision-making and effectiveness at the regulatory interface. A focus on the approval and whole lifecycle of the product, and not just the submission, will influence the quality and direction of the content. Traceability is key in all respects of the creation of information, from data that leads to knowledgeable decisions and the ultimate wisdom that forms the label of a product.

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Topics: Regulatory Requirements, ISS/ISE, FDA, Integrated Summaries, Medical Writing, Biostatistics Consulting, Phase 3 Studies, Phase 2 Studies, Statistics

Assessing Equivalence in Rheumatoid Arthritis in Clinical Trials

Statistical Consultancy Team

In Rheumatoid Arthritis (RA) clinical trials, treatment response is often assessed via the American College of Rhematology (ACR) composite responder score ACR20. This is a binary criterion that incorporates several indices of treatment activity in terms of symptoms reduction and is equal to 1 if at least 20% of improvement between a baseline and post-baseline measurement is observed in tender and swollen joint counts, in at least three out of five other indicators (C-Reactive Protein, patient global assessment of disease activity, physician global assessment of disease activity, patient pain scale, Health Assessment Questionnaire Disability Index), and 0 otherwise.

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Topics: Statistical Programming, Biostatistics Consulting, Rheumatoid Arthritis (RA), PROC NLMIXED

Understanding the Proportional Odds Assumption in Clinical Trials

Statistical Consultancy Team


Ordinal scales are commonly used to assess clinical outcomes; however, the choice of analysis is often sub-optimal.  In 2007, the Optimising Analysis of Stroke Trials (OAST) collaboration showed that ordinal-appropriate analyses of ordinal stroke outcome scales were preferable over binary analysis of a chosen ‘favourable’ outcome[1] but uptake of ordinal methods between 2007 and 2014 has been low [2].

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Topics: Randomization, SAS Programming, Biostatistics Consulting, Statistics, Ordinal Logistic Regression, Proportional Odds Assumption, PROC Logistic, Neurology

The Role of a Statistician In a Pre-Clinical Study

Statistical Consultancy Team

Pre-clinical trials, involving experiments in-vitro (literally ‘in glass’, i.e. in the laboratory, typically involving cells) and in-vivo (‘in animals’) are an essential part of drug development as it is a regulatory requirement  to investigate the safety of new drugs in-vitro and/or in-vivo before they are tested in humans. These trials can also be used to investigate the potential efficacy of new compounds.

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Topics: Pharmacokinetics and Pharmacodynamic, Randomization, Specialist Biometrics CRO, Pre-Clinical Study, Biostatistics Consulting

Comparing treatment response curves: a practical example in rheumatoid arthritis

Statistical Consultancy Team

Nowadays, more and more studies are being designed to collect information on treatment response at several time points during the treatment period of the study. Although the primary endpoint is often the comparison at the end of the study of the absolute response or of the change to baseline between study treatments, analyses involving intermediate time points in the assessment of treatment effects, e.g., repeated measures modeling, are now widely used.

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Topics: Programming R, SAS Programming, Therapeutic Areas, Biostatistics Consulting, Phase 3 Studies, Rheumatoid Arthritis (RA), PROC NLMIXED, PROC IML

Utilizing a Bayesian Informative Prior to Reduce Sample Size in Clinical Trials

Statistical Consultancy Team

Bayesian_Informative_Prior_to_Reduce_Sample_Size_in_Clinical_Trials

Bayesian statistics in clinical trials are becoming more widely used in the pharmaceutical industry. By gathering data from historical studies, it is possible to reduce the sample size of the current trial by using an informative prior in the Bayesian analysis. This blog explores five cases in different indications that have historical data on placebo subjects from the literature, and calculates the effective sample size using an informative prior. In some cases, the effective sample size is substantial, but in others there are no sample size savings despite abundant data in the literature.

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Topics: Bayesian Statistics, Bayesian Methods, Statistical Programming, Biostatistics Consulting

7 Frequently asked Questions on Clinical Study Design

Statistical Consultancy Team

Quanticate has released several white papers around Clinical Study Design in the area of Bayesian Statistics and a focus on Phase 1 studies. Our statistical consultancy team was pleased to receive feedback and questions from our clients and piers on these papers which we would like to share with you all below.

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Topics: Bayesian Statistics, Bayesian Study Design, Bayesian Methods, Phase I Studies, Clinical Study Design, Interim Analysis, Biostatistics Consulting, Phase I Study Design

How a Centralized Approach to Data Impacts Clinical Study Design

Statistical Consultancy Team

 

In today’s environment, one of the keys to accelerating drug development decisions comes from ready access to historical data. The introduction of the Centralized Service Provision (CSP) enables data across study phases and programmes to be accessed as easily as within the same study, due to the commonality of structure.

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Topics: Standardization, Clinical Study Design, Centralization, Biostatistics Consulting, Visualization

PK data analysis and reporting: SAS or Phoenix WinNonlin?

Statistical Consultancy Team

 

  

SAS [1] is regarded as the industry standard for clinical data analysis and reporting; however, Phoenix WinNonlin[2], which is a powerful tool tailored to the specific demands of PK data, is widely accepted as the industry standard for PK data analyses. This widespread separation of responsibilities, and the resultant transfer of data between software applications (and in many cases departments), has the potential to not only cause significant reporting delays, but can also lead to incohesive clinical study reports (CSRs) containing tables, listings and figures (TLFs) derived from various different sources.

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Topics: Pharmacokinetics and Pharmacodynamic, Clinical Study Report, SAS Programming, Biostatistics Consulting, PK Analysis

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