Monday, January 25, 2016
Last week, an appeals court affirmed the 57-month prison sentence for a former Iowa State University researcher who falsified the results of an HIV vaccine experiment. Also last week, a GlaxoSmithKline (GSK) biostatistician who blew the whistle on significant flaws with Nicoderm studies claims to have been fired as a result.
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.
About a fifth of cancer clinical trials fail to attract enough participants to produce useful data, and researchers could save time and money before a trial launch by using a recruitment-success prediction tool that measures the recruitment risk of a trial.
The Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the FDA and Duke University, has unveiled a new model for the informed consent process designed to improve the ability of patients to make educated decisions about clinical research participation.
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.
BioClinica, a diversified contract clinical trials services provider, has bought global patient recruitment and retention firm MediciGroup. The acquisition continues consolidation of the patient recruitment services market.
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.
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.