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International Clinical Trials

Engaging the Crowds

More than 80 novel therapies for Alzheimer’s disease (AD) were evaluated in clinical trials in the past decade. Yet, to date, all have failed, which raises the following questions: what led to this series of failures? Were the therapeutic targets (amyloid, BACE, gammasecretase) wrong? Were there underlying methodological mistakes (1-2)?

Going one step further, after these apparent clinical trial failures, how do we then motivate individuals to contribute to preventive clinical trials for neurodegeneration that do not provide any observable benefit? Answering this question is critical to successful patient engagement of future studies, since only about 6% of patients with a severe disease participate in clinical trials – not to mention the fact that the percentage of symptom-free individuals willing to participate is most likely even lower (3).

One solution to engaging patients may be by leveraging patient registries. Here, we discuss the opportunity for patient-centric registries to improve patient engagement in AD clinical trials, resulting in the potential to decrease study failure rates.

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Peter Schueler, MD, is Senior Vice President of Drug Development, Neurosciences, and is board certified in Neurology and Pharmaceutical Medicine (Swiss Medical Association). After his medical education he worked in the pharmaceutical industry, and since 2000 has worked in the CRO world, being with ICON since 2007. He has been first author on over 40 publications on drug development and drug safety. In 2015 his book ‘Re-engineering Clinical Trials’ was published by Elsevier. He continues to lecture Pharmaceutical Medicine at the University of Duisburg-Essen and at the European Center Pharmaceutical Medicine (ECPM), Basel, Switzerland.

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