The breakthrough drug initiative has accelerated the development and approval of highly effective therapies, enabling important new medicines to reach patients sooner, according to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER). Twelve breakthrough drugs have been approved over the past two years for several critical conditions in addition to cancer, and dozens more are in the pipeline, Woodcock reported in mid-November at a conference sponsored by the Friends of Cancer Research and the Bookings Institution. The response to the breakthrough program by sponsors has “exceeded expectations” and is “good news for patients,” she added. But it also puts pressure on manufacturers to address formulation, stability and quality production issues very early in development, she said. Read More »
US researchers and regulators continue to support the use of randomized clinical trials to test potential treatments and vaccines to combat the Ebola virus, despite objections that this approach is unethical and unfair to vulnerable populations. Anthony Fauci, director of the National Institute of Allergy & Infectious Diseases (NIAID), articulated the case for “gold-standard” randomized trials at a hearing before the House Energy & Commerce Health subcommittee last month. Read More »
The New York Times (NYT) reported on Dec. 1, 2014 that companies in the biotechnology sector might be the latest victims of computer security breaches. The perpetrators, who are thought to be former investment bankers, are using the information they glean to obtain a market edge on the pharmaceutical industry. Read More »
For Moe Alsumidaie, the most concrete definition for patient centricity is “a dynamic process through which the patient regulates the flow of information to and from him/her via multiple pathways to exercise choice that is consistent with his/her preferences, values and beliefs. This fundamentally transformative concept affects how healthcare decisions are made and who has the authority to make them.”
But patient centricity is ultimately interpreted by the eye of the beholder. So how can we better focus on involving the patient in the drug development process? This Applied Clinical Trials article offers a few insights about changing trends in patient centricity.