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International Clinical Trials

Comment from the Editor

It is probably not well-recognised that lung cancer is the leading cause of cancer death across the globe. In fact, it claims more lives than the next three most common cancers combined (colon, breast and pancreatic), says Amit Mehta at Intrinsic Imaging. Until very recently, the fight against non-small cell lung cancer (NSCLC), in particular, has been led by computed tomography imaging to aid early detection – one of the main reasons for poor patient survival rates being the advanced state of the disease on presentation.

Delving into this further, the author discusses how the last decade has seen an appreciation of the genetic basis of cancer, which has enabled research to identify more effective targeted therapies for specific genetic mutations that cause the cancer. Tumour assessment is also playing a more prominent role in enhancing our understanding, and this article outlines a number of imaging techniques being increasingly applied.

While this development of novel genetic-based therapies for NSCLC has opened a new treatment window for late-stage disease – and the radiology community is working to establish new imaging biomarkers – imaging CROs will require highlevel expertise to perform trials evaluating these therapies.

Looking at a different form of cancer, Jason D Hurt from Medpace explains how drugs for gynaecological cancers in the US have struggled to gain approval – but that 2014 has proved a turning point, giving fresh hope to the nearly 100,000 women affected each year. Progress in this area has been slowed by issues around study design, identifying suitable endpoints, and barriers to study enrolment. It is apparently a field where the many misconceptions held by patients and investigators must be resolved before further approvals are possible.

R&D behind treatments for lung and gynaecological cancers benefits from the ongoing drive towards personalised medicine. In trials, the individual pathology of these diseases is investigated by central laboratories, which must overcome challenges relating to sample analysis and uniform reading interpretation on a global scale. Kathryn Bowers and Desa Rae Pastore of ACM Global Central Laboratory explore this in more detail. One of the notable drivers here is communication and knowledge-sharing between laboratories and study sites – crucial to consistent interpretation of pathology samples. The contributors also note that pathology is still regarded as "an art as well as a science" and will continue to play a significant role in clinical research.

Elsewhere in this edition, we consider study feasibility. Today, when the cost of drug development may well exceed $2 billion per successful product, well-designed preliminary feasibility assessment is seen as a vital first step in clinical studies which, after all, contribute massively to this cost. United BioSource Corporation's Bruce Smith describes some strategies sponsors can take.

Five critical questions are posed covering epidemiology, the trial environment, geography, ethics approval and the state of the real world with respect to the projected study. Adding to the debate, Paul Evans and Xavier Flinois at PAREXEL highlight how advanced technology being utilised by eCROs can affect feasibility – evaluating patient experience and site intelligence to enable data-reinforced decisions.

Another subject in this edition is cardiac safety studies – articles consider the take-up of high-precision QT analysis and the management of electrocardiogram equipment. And the global nature of trials is reflected in analyses of the Asia-Pacific region, emerging from the shadow of BRIC nations, and Good Clinical Practice non-compliance in Russia. Lots to absorb and take on board.

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