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International Clinical Trials

Editorial Comment

Metabolism is the process your body uses to get or make energy from the food you eat. A metabolic disorder occurs when abnormal chemical reactions in the body disrupt this process. When this happens, you might have too much of some substances or too little of others to stay healthy.

As Tatiana Souslova at ACM Global Central Laboratory points out, metabolic syndrome is somewhat different, but is a serious health condition which is defined as a cluster of metabolic risk factors that can increase the chances of developing cardiovascular diseases and diabetes. These risk factors were first identified more than 250 years ago, and one would think they have been around for all of human existence.

However, metabolic syndrome has only been officially recognised since 1989 – rather surprising, given that its prevalence is rising dramatically and, according to the American Heart Association, it now affects one in three US adults. Clinical laboratories are playing a central role in detecting it, and current technologies allow these labs to provide healthcare providers and trial sponsors with rapid, accurate results to aid prevention and treatment.

Jim Wang of Crown Bioscience discusses a rather different but, again, very common metabolic disease – diabetes mellitus. He explains that preclinical techniques, such as models that closely reflect the patient population and disease complexities, can help streamline Phase 2 trial designs and thus get vital medicines to patients faster. The author demonstrates this with a case study of diabetic monkeys with albuminuria, showing that identifying the unique gene signatures of these animals may have significant relevance to clinical diabetes diagnosis and therapies.

New Era of Transparency

‘Big data’ is the term for a collection of datasets so large and complex that it becomes difficult to process using on-hand database management tools or traditional data processing applications. The challenges include capture, curation, storage, search, sharing, transfer, analysis and visualisation. One might say that pharmaceutical big data is a consequence of the ever-greater transparency being demanded by both regulators and the wider public.

PRA’s Gareth Adams discusses the impact of this new era of transparency, and the use of analytics and non-traditional data sources. He takes the view that cultural changes will occur within the industry, with a move away from its ingrained insistency on data quality and precision, and towards a more risk-based approach. Looking ahead, big data analytics will allow us to model and shape data in ways not done before. We should be able to identify risks and quality issues not encompassed or defined in current data collection and review methodologies, and resolve issues much earlier in the data collection and cleaning process.

Direction of Debate

The transparency issues facing pharma and biotech are further explored by Mathias Poensgen, Jessica Schell and Simon Wilson at ArisGlobal. They trace the recent history of the debate and outline the advantages in terms of industry research and reputation – but also ponder the potentially negative implications of posting data on trial participants.

Casting an eye to the future, the authors ask: “What else could be published? What about patient safety and efficacy? Will trial transparency be needed in preclinical trials before clinical development occurs in human research? Will we see requests to publish complete pharmacological and toxicology trial results in this decade?”

They also consider marketing, and conclude that this is another direction that the debate could take. Considering the level of focus on trial data transparency, marketing activities might well be the next area to target in the clinical research industry. Clearly, this would be a daunting prospect for pharma companies.

As ever, this edition of ICT contains the usual eclectic mix of insightful articles, with oncology studies, laboratory networks, payment methodologies and the BRIC market among the mix of other subjects covered. I hope that you enjoy dipping into them.

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