Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND
FDA: 9/1/13 This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators,2 and institutional review boards (IRBs) in determining whether research studies involving human subjects must be conducted under an investigational new drug application (IND), as described in title 21 of the Code of Federal Regulations, part 312 (21 CFR part 312) (the IND regulations). This […]
Patients have a right to participate in risky research
MNT: Sep 18, 2013 Individuals have a right to participate in risky research trials, which might harm their health or even kill them, and institutional review boards (known as research ethics committees in the UK) – which are responsible for deciding whether a particular research trial can take place in a given institution – are […]
Impact of patient involvement in mental health research: longitudinal study
Bjp.rcpsych: September 12, 2013 It is deemed good practice to involve patients routinely in research but no study has investigated the practical benefits, particularly to successful recruitment. Aims To identify whether patient involvement is associated with study success. Method All studies listed on the Mental Health Research Network (MHRN) portfolio database (n = 374) were interrogated using […]
NIH scientists pursue new therapies to improve rare disease drug development
NIH: September 12, 2013 Four new pre-clinical drug development projects at the National Institutes of Health will target a form of blindness and diseases characterized by cardiac problems. The projects were selected for their potential to treat specific rare diseases and to help scientists uncover new information that can be shared with other researchers. The […]
More Than 270 Vaccines in Biopharmaceutical Pipeline Offer Hope to Prevent/Treat Wide Array of Diseases
Phrma.: 9/11/13 WASHINGTON, D.C. (September 11, 2013) – America’s biopharmaceutical companies are currently developing 271 vaccines to prevent – and in some cases treat – a variety of conditions, including infectious diseases, various forms of cancer and neurological disorders, according to a new report by the Pharmaceutical Research and Manufacturers of America (PhRMA). The report is being released in […]
System Transformation Intensifies Demand for Evidence: The Trust Conundrum
Health Affairs: 9/10/13 Although we have witnessed historic lows in the rate of growth of healthcare spending, the implementation of the Affordable Care Act and secular trends have created fundamentally new dynamics in how providers, clinicians, and patients are exposed to the cost of care. New payment and delivery models being tested by the Center for […]
Race-Based Medicine?
Project Syndicate: Sep. 10, 2013 PALO ALTO – Race can undoubtedly be a tricky subject, with any suggestion of genetic differences among racial groups – beyond superficial characteristics like skin color – potentially invoking memories of the nineteenth-century eugenics movement and its eventual role in Nazi ideology. Now, with drug companies increasingly seeking to develop medications […]
