PHASTAR at PSI 2018

PHASTAR at PSI 2018

The 41st annual PSI 2018 conference was held in Amsterdam from 3rd to 6th June with the theme “Breaking Boundaries in Drug Development”. The conference witnessed a new record of 391 attendees in total, with a 20% increase on abstract submissions compared to 2017.

The first keynote speaker at the conference focused on the future of healthcare, discussing growing pressures on the healthcare industry due to the changing demographics of the world, improvements in technological development and a comparison between the Dutch and other European healthcare systems. The second keynote speaker compared statistics with the newly evolving discipline of data science and whether statisticians should reinvent themselves to stay relevant and play a bigger role that goes beyond clinical development and R&D.

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Programming considerations for trials focusing on Personalised Medicine

Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose.

The number and range of medications already referencing pharmacogenomics can be found at Drugs@FDA, providing an extensive list  of therapeutic products with pharmacogenomic information found in the drug labelling, with a few of these medications shown in the table below.  The labelling for some, but not all, of the products includes specific actions to be taken based on the biomarker information.

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ACDM Annual Conference - Summary

PHASTAR recently attended the ACDM conference in Brussels.  The programme was full and interesting, with plenty of scope for questions and discussion throughout the day.

There was some time spent reminiscing and reflecting, since two of the presentations covered developments in Clinical Data Management and Coding over the last 30 years.  Taking the time to think back over the changes in the scale and complexity of clinical trials over that timescale, and of course the technological and regulatory advancements in our discipline, was fascinating.  We learnt that coding as we know it today originated with Dr Napke in the 1970s, organising pharmacovigilance reports in pigeonholes.

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Medrio mSquared Conference - Summary

In March 2018, PHASTAR attended mSquared -  Medrio’s annual user conference in San Francisco.  The conference hosted CROs, sponsors and other organisations from around the globe.  It was an opportunity to learn first-hand about Medrio’s new products and features and to get a preview of the work Medrio are doing to further accelerate and enhance processes. There was plenty of opportunity to exchange ideas and user hints and tips at workshops and personalised training sessions.  

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PHASTAR, the ‘five rights’ and personalised medicine

Personalised medicine is a move away from the ‘one size fits all’ approach to the treatment and care of patients, to one which uses new approaches to better manage patients’ health and targets therapies to achieve the best outcomes in the management of a patient’s disease or predisposition to disease[1]. With substantial and increasing medication use globally comes a growing risk of harm associated with such medication[2]. Medication error can be defined as a reduction in the probability of treatment being timely and effective, or an increase in the risk of harm relating to medicines and prescribing compared with generally accepted practice[3]. The Institute for Healthcare Improvement (IHI) has described the ‘five rights’ of medication administration in order to try and reduce medication error. These are; the right patient, the right drug, the right dose, the right route and the right time[4]. Patient centred care, along with this long awaited personalised approach, is now more relevant and necessary than ever as the complexities of the human body are increasingly understood.

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