A Review of the Annual PhUSE 2016 Conference

Clinical Programming Team

A number of team members were able to represent Quanticate at the PhUSE 2016 annual conference in Barcelona. The PhUSE annual conference is an opportunity for programmers and statisticians to both learn from and share cutting edge knowledge with the pharmaceutical industry. This year, Quanticate presented on producing high quality SAS graphics using the advanced Graphical Template Language (GTL) to bring individual plots together to aid analysis without sacrificing any aesthetical properties in the process. Conference attendees were spoilt for choice with approximately 5 simultaneous presentations every half-hour across 15 streams in total. Here are some interesting presentations which the team enjoyed over the conference duration.

 

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Topics: Programming R, Clinical Programming, SAS Programming, Visualization, Conferences, SAS Graph

The Evolution of Risk-Based & Remote Monitoring

Gavin Boodoo

With a growing trend towards the use of risk-based monitoring, and with new technologies available to support this alternative to traditional onsite monitoring, there remains inertia to implement this approach. Having discussed remote monitoring capabilities with industry peers, we have identified the root cause of this reluctance as an intrinsic fear of flouting regulatory compliance within the conduct of a clinical trial.

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Topics: Regulatory Requirements, Clinical Trials, FDA, Remote Monitoring, Remote Data Capture, Source Data Verification (SDV), On-Site Monitoring, Risk Based Monitoring, Centralized Monitoring

A Guide to the Benefits of Centralized Clinical Data

Commercial Team

If a pharmaceutical, biotech or medical device company outsources its clinical trials, it may be neither practical nor advisable to use one single Clinical Research Organization (CRO). Smaller CROs may not have the infrastructure to deliver large multinational trials, and large CROs may not offer the level of attention or flexibility required for smaller, but no less important, clinical studies. However, whilst the choice of CRO may be study dependent for the clinical aspects (such as patient recruitment, monitoring, clinical project management and regulatory expertise) there are tangible advantages to centralizing all data handling activities with a single provider – one that supports clinical data management, biostatistics, pharmacovigilance and medical writing services.

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Topics: Clinical Trials, CRO Selection, Clinical Data Storage, Centralization, CRO Project, CRO Efficiency, Clinical Data Services, Functional Outsourcing

How Well Written Proposals Affect Clinical Research Organization Selection

Commercial Team

Selecting the right Clinical Research Organization (CRO) is vital to the success of any clinical study. Get it right and the months that follow will be that much more enjoyable because the study is more likely to run smoothly and stay within budget. Those sponsors who have had to transition a clinical study away from a poorly performing CRO to an alternative supplier, mid-study, will be acutely aware of the pain that this can cause and the need for a thorough vendor selection process. The Request For Proposal (RFP) is a vital component of that process. A well-defined and comprehensive RFP creates the best chance of selecting the most appropriate CRO, or combination of CROs, to complete the project.

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Topics: CRO Selection, Centralization, CRO Project, CRO Efficiency, Clinical Research Organization, Clinical Data Services, Request For Proposals

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

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.

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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. 

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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.

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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? 

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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.

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

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