Quality deliverables - PHASTAR's programming perspective

Quality is paramount to all programming work carried out at PHASTAR to ensure accurate reporting and analysis of clinical trials.  In order to maintain our high standards, we have SOPs and Work Instructions that detail our standardised internal processes for SAS programming and QC across studies and sites.  

Other resources available to staff include our checklist of hints and tips collated from over 1500 years of industry experience, “The PHASTAR Discipline”; a CDISC specific checklist; and we also a run full day internal training course on delivering to quality that includes a practical workshop which is given to all new starters and offered as a refresher for experienced staff.

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SAS Art Competition 2017 - The Results

PHASTAR's annual SAS Art Competition closed at the end of November and it is time to reveal this year's winner!

Every year we are really impressed by the entries we receive from statisticians and SAS programmers; however, there can only be one winner...

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Considerations for Payer Reimbursement Assessments

Traditionally the focus of pharmaceutical development has been on generating evidence to satisfy regulatory authorities’ assessments of efficacy, safety, and quality.  There is increasing focus on the “4th hurdle to market entry” - the assessment by payers of newly approved products.  This is based on cost effectiveness – assessment of the value of the incremental benefit provided by a product.  One of the challenges in this area is the considerable variation in the evidence requirements across markets.  Regional variation also occurs in assessments for the registration of pharmaceuticals, but here ICH does provide harmonisation across the major markets on key principles.  

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Data Management Considerations for Adaptive Trial Designs

PHASTAR Data Management

 With the added weight of an FDA guidance document and the rapid advancement of the technology available for use, adaptive clinical trial designs are becoming much more appealing. In a nutshell, an adaptive trial involves the ongoing analysis and monitoring of unblinded data by a selected group of independent clinicians and statisticians at defined points during the trial, with the potential for study design changes. Utilising this approach, answers to questions not typically realised before the end of a study can be obtained. For instance; whether certain features of the trial need to be changed, whether the current enrolment target is sufficient to meet the defined statistical endpoints or, possibly, which dose amongst multiple treatment arms will be the most beneficial to the patient. The study team will, therefore, be in a position to propose and take counteractive steps much sooner. The decisions made based on these interim analyses can save on the potential failure of a study due to, for example, incorrect dose choices or miscalculated sample sizing and ensure that the chances of a successful study are optimised.

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PHASTAR at PhUSE 2017

A common theme from this year’s PhUSE was how Pharma and CRO companies are implementing efficiencies to all programming functions. Much of this stemmed from the use of standardised database designs (including CDASH standards) to build a Meta-data Repository (MDR) which promotes reusability across studies from SDTM mapping to define xml generation and much more (presentations: SI01 / DS11 / DH05). Some of the processes involve bespoke in house tools and/or fulltime standards teams to make this work but the huge effort looks to be rewarded with efficiency on the various study tasks.

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