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International Clinical Trials

Comment from the Editor

“Developing new antibiotics is daunting.” This stark line opens the article by Jon Bruss and Brian Murphy from Medpace, which explains the challenges in this area of drug development, while also suggesting that a steady revival in antibiotic R&D is on the cards.

For a major pharma company to develop a new antibiotic class is indeed a formidable task. What can make it especially difficult is that any breakthrough is liable to be restricted in the marketplace by those authorities responsible for its being prescribed, due to fear of rapid resistance being developed.

Antibiotics ought to be straightforward to develop – the related clinical trials will usually have a clear-cut and objective endpoint, and be relatively quick – yet Big Pharma has shied away in recent years. However, we could be at a turning point.

The authors claim that, spurred on by regulatory moves, smaller biotech firms are filling the void left where their bigger brothers have exited. Some 20 years ago, there were hundreds of new antibiotics at various stages of development; today, this number has shrunk to the mid-20s. But it is hoped that some of these will be seeking regulatory approval in the next few years, with non-industry funding key to their development.

True Companions

Personalised medicine is a topic that has been bubbling to the surface over the last few years, and part of this subject is the use of companion diagnostics. Alan Wookey at LabCorp Clinical Trials takes up the story, discussing how, after more than a decade of slow progress, these diagnostics are achieving a breakthrough. Industry collaboration and regulatory attention is, he says, leading to a rethink of laboratory developed tests which can streamline the route to approval of a diagnostic and a drug more or less simultaneously.

If a companion diagnostic is essential to the eventual prescribing of a drug, most drug companies will usually seek out a diagnostics partner. As such, this is an area where true strategic partnerships could lie, with both partners sharing development costs and the rewards.

Patient Motivation

In a clinical trial run by a contract research organisation (CRO), there exists a cascade of motivation: the sponsor must motivate the CRO, who must motivate its monitors, who must motivate its investigators, who in turn must motivate the patients at the core of the trial. A recent ISPE Patient Survey explored what patients think about the investigational medicinal products they receive in clinical trials. As Esther Sadler-Williams and Michelle Foust report, based on feedback from 1,400 participating patients, the survey found that subjects want to comply with a study’s requirements, but that customisation and accommodation of individual preferences is essential.

Getting Personal

The need for a personal touch in the running of clinical trials is also highlighted by Judith Teall at Exco InTouch. She explains how digital and mobile devices can offer a non-intrusive technology to increase motivation and compliance in patients, thereby generating high-quality data in a cost-effective way.

A case study she gives as an example involves a trial that used the patient’s own device. It is believed that the sponsor saved over $1 million in the first part of the study, and expects to save more than $3 million on completion.

Moreover, motivated and engaged patients are much easier to retain in clinical trials – a point emphasised by Elizabeth Puller and Liz Moench of MediciGlobal. They examine how an effective retention programme can be developed which has the right balance of motivation, education, engagement and expectation, as well as recommending regular review and adjustments of plans as necessary.

As ever, limited space prevents me drawing attention to the other thought-provoking articles that fill this edition of ICT, but I shall sign off by wishing all our readers and contributors a happy and prosperous 2014.

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