When the Clinical Leader team attended the 2017 DIA Annual Meeting in June, the topic we heard discussed more than any other was real-world evidence (RWE) — that is, information about a drug that is collected outside of clinical trials. RWE is not a new concept, but there are good reasons for all the current attention being paid to it in the pharma industry. For one, the 21st Century Cures Act, enacted into law in December 2016, seeks to speed the FDA drug and medical device approval processes by shifting some of the evidentiary requirements, in certain instances, from clinical trials to post-market — in other words, to “the real world.”
Practical discussions around inclusion often go something like this: A sponsor is interested in anticipating potential barriers to enrollment based on a newly drafted protocol.
When the Clinical Leader team attended the 2017 DIA Annual Meeting in June, the topic we heard discussed more than any other was real-world evidence (RWE) — that is, information about a drug that is collected outside of clinical trials. RWE is not a new concept, but there are good reasons for all the current attention being paid to it in the pharma industry. For one, the 21st Century Cures Act, enacted into law in December 2016, seeks to speed the FDA drug and medical device approval processes by shifting some of the evidentiary requirements, in certain instances, from clinical trials to post-market — in other words, to “the real world.”
Managing the investigator payment is one of the most challenging aspects of running a clinical trial. Major factors considered by pharmaceutical and biotech companies for investigator payments are therapeutic area of interest, duration of the trial, clinical phase, and patient enrollment.
New York City has long aspired to become a life sciences hub, but while the city seems to have all the elements necessary to foster such industry growth, it has continually fallen short of this goal. New York currently ranks a distant third behind both Greater Boston and the San Francisco Bay Area, and there’s some work to do if it hopes to catch up.
Clinical research is becoming more and more complex due to many factors, including increased regulations, competition for patients, and cost of conducting clinical trials. Most of the smaller pharmaceutical and biotech companies (sponsors) do not have the workforce to provide proper oversight of a clinical trial. This forces companies to outsource much, if not all, of the trial oversight to contract research organizations (CROs) and service providers (vendors).
On May 11, Scott Gottlieb, M.D., officially became the 23rd commissioner of the U.S. Food and Drug Administration (FDA). Dr. Gottlieb has previous FDA experience, having served as deputy commissioner for medical and scientific affairs, among other positions, during the George W. Bush administration.
Fall conference season is upon us and a cursory internet search shows no less than a half-dozen conferences focused on the topic of patient-centricity.
Real-world evidence is a hot topic in clinical research right now. But too often, the massive amounts of data now available from electronic medical records used in routine medical practice are being considered to be clinical evidence to support medical decision making. However, the process of transforming these large data sources into actionable evidence that can change clinical practice is a complicated but important endeavor.
Wall Street is wondering what’s next on Amazon’s shopping list, and pharmaceuticals may be a leading contender. Here are four patient touch points where Amazon can leverage its existing capabilities in conducting clinical trials and pharmaceutical development.
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