New Setting - Old Principles at ACDM 2017

ACDM 2017 - Conference Review

The ACDM Annual Conference 2017 was hosted in Brussels in a move away from the usual UK base, resulting in a truly European audience. The Chair of the ACDM welcomed us all and reminded us that throughout this transition period of new technologies and regulations to stay true to the QPR principles - Quality, Protection and Responsibility.

The two key note speakers brought a diversity of approaches to the meeting, from the impending implementation of regulations set out in ICH E6 (R2) in June 2017 and the move to Risk Based Monitoring (RBM) to the challenges faced by Médecins Sans Frontières (MSF) when delivering emergency aid in exceptionally difficult circumstances.

Aspects of e-data were central throughout the presentations, including it's role and contribution in the setting and monitoring of Tolerance limits, the quality measures required for Clinical Trials based on statistical and medical knowledge. The effect of eSource on EDC and the electronic Trial Master File (eTMF), centralised monitoring, monitoring strategies and Risk Indicators were key focal points for discussion together with how to address data security in a cloud based environment and best practices for implementing such applications.

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Interim Locks and DSMBs

Interim Locks and DSMBs                   

Special consideration needs to be given to providing data for interim locks and DSMBs during the course of a study. It is crucial that the data provided for these milestones is as complete, accurate and up-to-date as possible because the outcome can have serious implications on the review and progress of the study. 

It is essential for data management to plan in advance the identification of key data, the level of cleaning required and agree timelines with the project team.  This strategic planning requires input and commitment from wider study team:

  • For electronic-data-capture studies, site personnel need to commit to entering the key data and responding to queries in a timely manner. For paper studies, CRFs must be completed and sent to the Data Entry department. Phastar work closely with the sponsor, clinical project managers and CRAs to provide assistance if required in database issues and ensure new user accounts are set up promptly.
  • Source document verification of key data must be completed in time for data management review and query resolution.

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Spirit of Collaboration at PhUSE CSS 2017

PhUSE CSS 2017 - Conference Review

The USA hosted for the 6th consecutive year the PhUSE CSS (Computational Science Symposium) at Silver Spring with 325 attendees coming from many pharmaceutical companies, CROs, FDA and CDER. The CSS is an FDA/CDER and PhUSE co-sponsored meeting - the agency officially support the projects and recognise the successes the working groups every year. The CSS is a great opportunity to connect, share thoughts and ideas freely with a focus on sharing accomplished work publicly in order to help the industry and organise the next collaborations and actions. 

The keynote presentations were really interesting and discussed a wide range of topics from new eCTD rules and standards to improving FDA Non-clinical review capabilities for CDISC-SEND submission to how analytical tools are used for a NDA/BLA . It was also very interesting to hear how clinicians from the FDA review submissions and the different steps they go through during their review period and the hurdles they face during this process. The conference also had 2 hands-on workshops and 33 posters were presented.

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SAS Art Competition 2016 - The Results

SAS Art Competition 2016 - The Results

Once again, we have been very impressed by the variety of submissions sent in by statisticians and SAS programmers. There can only be one winner however...

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Meta-analysis - Some Considerations

Some considerations when planning the statistical approach to an IPD meta-analysis of time-to-event data

We recently undertook a meta-analysis of time-to-adverse-event data across 12 randomized controlled trials in chronic obstructive pulmonary disease and share a few lessons learned when planning and implementing this type of analyses. Meta-analysis of individual patient data (IPD) offers a number of advantages over the traditional meta-analysis of aggregate data - in particular the ability to reliably estimate covariate and interaction effects. IPD can be modelled in a ‘one-stage" analysis (fitting a single model to all trials simultaneously), or the trials can be modelled separately and summary statistics analysed using standard meta-analytic techniques, known as a ‘two-stage" approach. One-stage models are appealing when IPD are available, but two-stage approaches should not be discounted as they are simpler to implement (particularly if assuming random effects) and any loss of power appears to be small (Stewart et al. 2012, Fisher et al. 2011).

In our analysis we aimed to establish three things:

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