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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SCDM 2017 Annual Conference Summary

This year’s annual conference for the SCDM took place in Orlando. The venue was fortunately spared the forces of Hurricane Irma. Hurricane Maria had also threatened the area for the opening ceremony, but veered off into the Atlantic and left us to enjoy a very full programme of oral and poster presentations, panel and round table discussions and exhibitions.

The keynote presentation gave an insight into the FDA’s perspectives on clinical trials conducted outside the U.S. The talk discussed how European guidelines and directives and the GCP requirements for validation of data obtained through onsite inspections to assure data quality, integrity, and development of medical products were evaluated from an FDA perspective.  The SCDM are actively widening their presence outside the US and, together with presentations of this nature, will undoubtedly bring a wider appreciation and understanding of managing international clinical trials to their predominantly US based membership.

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SAS Tip for Categorising Calculated Values

SAS Programming Tip For Categorising Calculated Values

We derived a % result based on 2 values, using the simple formula based on a post and pre assessment:

AVAL=(postf-pref)/pref*100;

For 2 patients, we ran into issues when the following values were used:

subject 001: AVAL = (0.84-0.75)/0.75*100 = 12

subject 002: AVAL = (1.38-1.2)/1.2*100 = 15

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SAS Art Competition 2017

SAS Art Competition 2017 - Open to all

It's that time of year again!

We would like to invite all SAS users to take part in our annual art competition. The winning entry shall receive a £500 shopping token (which can be donated to your chosen charity, if preferred). The entries should be sent to This email address is being protected from spambots. You need JavaScript enabled to view it. by 5pm UK time on Friday 24th November 2017. We would ideally like the artwork to be printable in large format (A0 or 1 metre square approximately) though the file can be sent as either a bitmap or JPEG file in smaller format. Please include the SAS code and graphic in your email, along with any other explanation required to understand and/or interpret the artwork. All entries should incorporate at least one of the colours in the PHASTAR logo (the darker colour is cx73002E and the lighter colour is CXAF95A6).

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