EAU15: Personalised medicine: clinical trials are crucial

20 March 2015

The need for personalized medicine will further expand as patient demand for efficient therapy with less side effects increases, on the one hand, and medicine develops gene-based diagnostics and sophisticated imaging techniques, on the other.

‘This roundtable meeting recognises the need for personalized medicine as we move away from old diagnoses and therapies to those which specifically identifies high-risk from low-risk diseases,” said session chairman Arnulf Stenzl (DE).

The panel included Didier Jacqmin (FR) who defined the current understanding of personalised medicine and also spoke on the impact of economic costs; Freddie Hamdy (GB) who gave an update on clinical trial design adapted to personalised medicine; Thorsten Bach (DE) who provided an overview of the EAU’s Patient Information project and its influence on clinical studies, and clinical pharmacologist Michael Schwab who presented pathways in precision medicine, particularly in lung and kidney cancers.

Despite the apparent need for personalised medicine, the panel experts underscored that current conditions are still fraught with challenges as they urged more support for clinical trials and the development and optimal use of medical therapies.

“There are many agents that work but we don’t see the effect because the tumour volume is too high. The crucial task is to identify patients with high-risk disease and act within the (limited) window of opportunity,” noted Hamdy.

Hamdy said precision cancer therapy is basically physically, physiologically and molecularly targeted, which implies that diagnosis tests would involve, among others, deep genome sequencing, and tests which are biomarker-driven and biologically-targeted.

According to Hamdy, the future of precision cancer trials will hinged on genomics, targeted agents, functional and molecular imaging, particle therapy and robotic surgery. With regards functional imaging tools, he added there are several options, among them are positron emission tomography (PET), single photon emission computed tomography (SPECT), functional magnetic resonance imaging (fMRI) and functional photoacoustic microscopy (fPAM).

In response, Jacqmin said personalised treatment also entails both cost savings and cost burden, the latter due to longer and expensive clinical trials, fewer patient numbers in these clinical trials and the need for companion diagnostic tools, to name a few.

He enumerated possible solutions to reduce costs, such as new designs for clinical trials (CT) in agreement with the European Medical Association (EMA), the creation of a unique portal for initiation of CT and access to all the results of CT performed to avoid duplication. Another challenge for researchers is to base their clinical trials on molecular target instead of a disease to improve patient recruitment.

Meanwhile, Bach gave an overview of the importance of educating patients which is the main goal of the EAU’s Patient Information. He said the website and associated printed materials, which offer unbiased, guideline-coherent leaflets to patients in easy-to-understand content, cover seven urological diseases and have been translated into several languages.

“With the proper information and guidance, we can harness the cooperation of patients in clinical trials,” he said whilst noting that some patients, for example, refused genetic testing and related diagnostics due to fear and misconceptions.

Stenzl expects the issue of personalised medicine to expand and increasingly occupy an important role. “The topic of personalised medicine will certainly be of crucial importance in the coming years and we need to further examine and look into the consequences and potential,” he said.