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.

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

Creating High Quality Graphics in Clinical SAS Programming

Statistical Consultancy Team

Utilizing the newer SAS graphical procedures such as SGPLOT and SGPANEL rather than the original SAS Graph procedures is becoming more and more popular in clinical SAS programming through their many user friendly utilities, such as overlaying multiple graphics and adding reference lines with ease. However, as with its predecessor, SAS Graph, any requirement for restructure of the graphical elements still proves to be relatively rigid when sticking to these core graphical procedures. This usually results in creating bespoke program code for each figure which undoubtedly takes time and also runs the risk of inconsistencies across figures.

Read More
Topics: Clinical Programming, SAS Programming, SAS Graph, PROC Template

Delayed-entry models using PROC PHREG in Survival Analysis

Statistical Consultancy Team

Time-to-event data often arise in clinical research, and in many cases represent the primary outcome of interest. These data generally represent the elapsed time between a reference time-point (e.g., treatment randomization) and an event of interest (e.g. death, relapse, etc.).

Whereas right censoring is a feature that is easily accommodated by most existing software, the same doesn’t strictly hold for another feature of survival data, left-truncation. In this post we’ll describe what left-truncation is, when it can arise and provide some SAS code that can be used to derive survival estimates and curves. 

Read More
Topics: Survival Analysis, Statistical Programming, SAS Programming, SAS, PROC PHREG

Electronic Data Capture Systems In Clinical Data Management: The myths and the reality

Clear Clinica

This post is a guest blog written by David Tashjian from Clear Clinica. The views and opinions in this post are not representative of Quanticate. By publishing Guest blog posts it does not imply Quanticate has a working relationship with any companies associated with a post and we are happy to receive guest blogs from any industry related company.

Read More
Topics: Clinical Data Storage, Case Report Form (CRF), Electronic Data Capture, Phase 3 Studies, Clinical Data Management, Paper-Based Studies

The Rise of Risk Based Monitoring [Infographic]

Thomas Underwood

Risk Based Monitoring is a term that is not new to the pharmaceutical industry. With increasing demand for budget reduction and reduced time to submission in drug development, both sponsors and vendors are seeking ways to reduce costs whilst still maintaining and potentially improving the quality of the data collected in clinical trials. Study costs can rise considerably for clinical trials with a large number of sites, especially across multiple countries. Risk Based Monitoring can reduce study costs considerably as there is a reduction in the need for CRAs to travel to sites, especially when coupled with a remote monitoring component. Also a reduction in the need to monitor all clinical trial sites and 100% of trial data, as those which are identified as more risk prone are visited more frequently according to targeted or triggered formulas. Even the FDA understands and encourages the desire to move away from 100% source data verification. Why therefore is the general mind-set in clinical operations exhibiting a degree of inertia to change with regard to RBM techniques? 

Read More
Topics: Clinical Trials, Remote Monitoring, Electronic Data Capture, e-Clinical, Source Data Verification (SDV), Adverse Events (AEs), On-Site Monitoring, Serious Adverse Events (SAEs), Clinical Trial Phases, Additional Monitoring, Phase 2 Studies, Technology Trends, CRAs, Risk Based Monitoring

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.

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

mHealth Apps and Wearables in Clinical Trials to Consider

Nick Burch

Today, mHealth, Mobile Health, Mobile Apps and Wearables are hot topics with consumers and regulators alike. We're also starting to see consumer-grade wearables and mHealth technologies creeping into clinical trials. We've written this blog for those looking to use this area more.

Read More
Topics: Regulatory Requirements, FDA, European Medicines Agency, Quality Assurance, Mobile Device, Technology Trends, Wearables in Clinical Trials, Wearables, mHealth

Is Lack of Data the Biggest Challenge for Early Phase Pharmacovigilance?

Pharmacovigilance Team

We recently hosted a webinar on the challenges of Pharmacovigilance in early phase clinical trials. During the registration process we had the chance to survey members of the industry, 70% of the respondents were from pharmaceutical, biotechnology or medical device companies. We wanted to present the data from the 150 respondents in this blog.

Read More
Topics: Regulatory Requirements, FDA, Phase I Studies, Adverse Events (AEs), Pharmacovigilance, Serious Adverse Events (SAEs), Clinical Trial Phases, Oncology

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].

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

Celebrating International Clinical Trials Day

Marketing Quanticate

Happy International Clinical Trials Day! For those of you who do not know, International Clinical Trials Day is celebrated each year on 20th May. The event was created to commemorate the day James Lind started the first ever clinical trial to try and cure the deadly disease scurvy.

The clinical trial James Lind conducted consisted of using citrus fruit to cure scurvy. At the time the concept of vitamins were unknown, today we know scurvy is a result of vitamin C deficiency. James Lind was the first to study the effects of citrus fruits by conducting a systematic experiment on sailors in 1747 which is now regarded as one of the first clinical experiments in the history of medicine. 

Read More
Topics: Clinical Trials, Ethics, Clinical Data Services, Statistics, International Clinical Trial Day

Welcome to The Quanticate Blog

We aim to provide information and support written by our experienced staff. We want to share our knowledge and create an archive of information that you will be able to engage with, share and comment on.

Subscribe to Email Updates

Blog Suggestions

Posts by Topic

Expand all