Weekly Features

Wearables track drug effectiveness in Parkinson’s patients

Monday, January 18, 2016

Cynapsus and the Michael J. Fox Foundation (MJFF) are partnering to incorporate a wearable device into a phase III study of patients with Parkinson’s disease. Similar to a smartwatch, the device is equipped with motion sensors to detect when patients have an “OFF” episode—a period where medicine stops working and motor impairment symptoms return. The symptoms include muscle stiffness or problems with starting movements, such as starting to walk or getting out of a chair.

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AB Science warned about putting study volunteers in danger

Monday, July 27, 2015

The FDA’s Office of Scientific Investigations has issued a warning letter to Paris-based AB Science, a pharmaceutical company that targets cancer and other diseases with high unmet medical need, for compromising the safety of study participants by failing to properly monitor its clinical trials and ensure investigators follow protocol requirements.

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FDA selects eight new patient groups for input

Monday, July 20, 2015

The FDA released a list of eight new conditions that it plans to assess during the next two years as part of its Patient-Focused Drug Development (PFDD) program. The program seeks to inform regulatory decision-making by soliciting patients’ perspectives on their diseases, treatment options and preferred endpoints for experimental therapies.

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Integrated research partnerships build momentum

Wednesday, July 1, 2015

Anticipating the convergence of health­care and clinical research to form learning health systems, a handful of organizations—some originating within the dedicated site network community, others within academia and the Veterans Affairs sys­tem—are partnering with community hospi­tals and large healthcare systems to transform the investigative site landscape.

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