Quanticate CRO Blog

Following on from the first post on Integrated Summary Tips in our blog we can continue to explore these below:

Survival models are commonly used in clinical trials as they are designed to perform 'time to event' analyzes on data with censored observations – something that probably all clinical programmers are familiar with. As censored observation in this case we understand a subject who did not experience the defined event during the whole observation period.

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.

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.

A member of Quanticate's Statistical Consultancy Team writes about their attentedence and presentation at the European Statistical Forum, Milan Nov, 2011.

Regulatory Medical Writing is often overlooked in the world of Medical Communications.  Regulatory writing, though perhaps less glamorous then the production of conference brochures and magazine articles, is a vital facet of clinical research.  To summarize, regulatory writing involves the production of documentation required for the approval of drugs by the regulatory authorities.  These national agencies (United States: FDA, Canada: Health Canada, European Union: European Medicines Agency [EMA], and Japan: Ministry of Health, Labour and Welfare in Japan) assess the efficacy and safety of drugs throughout the clinical trials process and ultimately approve their use in a specified patient population.  A Regulatory Medical Writer could be expected to work on a whole range of documentation including, but not limited to, Investigator’s Brochures, Clinical Protocols, Patient Information Sheets, Clinical Study Reports, and high level overviews for the Common Technical Document.  They will also be expected to work in a range of therapeutic areas, having to adapt quickly to new areas of research.

There has been increased interest across the life sciences industry to use lower cost regions such as India, China, Eastern Europe, South America and South Africa to support functions including clinical data management, statistical programming, biostatistics, pharmacovigilance and medical writing within clinical development and safety monitoring areas.  As such, I have seen lots of discussion occurring within companies and at congresses around what tasks should be moved off-shore and which should remain either in-house or outsourced locally.  Undoubtedly, there is a benefit to using optimal locations to support these functions given the growing focus on driving drug development cost savings, but the question is usually around what the best structure should look like. 

We are pleased to confirm that Quanticate will have a speaker at the 2011 European Statistical Forum (ESF) Conference. Entitled “Bayesian Study Design for Survival Endpoints: Enhancing decision making in early clinical development”, the talk will focus on Phase II, or ‘Proof of Concept’ studies. These types of trials can be large and expensive and at a stage in development where there remains considerable uncertainty about the chance of success. This talk will introduce Bayesian methods and show how they can be applied to help clinical development teams design smarter, pragmatic and more informative phase II trials.  Using a case study from oncology, some of the concepts of Bayesian methodology that are re-defining the approach in early phase development will be introduced. Graphics will be used to illustrate the properties of alternative designs and the benefits of adopting the Bayesian approach will be discussed.

Establishing robust metrics at the start of a study, and systems to monitor them in an ongoing manner, should be integral to all work that a Clinical Research Organisation (CRO) performs.  Metrics should be used to monitor progress (or lack of progress), and should record deviations from the planned schedule.