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Mar 31, 2015

Sentiment analysis is a methodology that is already quite widely used in the consumer goods industry to drive marketing campaigns. The same methodology can give health care organizations a competitive edge in understanding what customers think about their healthcare experience, to help reduce costs and improve care service and to lead to new clinical research and treatments. In addition, it taps into a new channel of pharmacovigilance input information that can enable Marketing Authorization Holders to keep abreast of opinions on the safety of their products in real time.

This guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.

Understanding study site engagement is very important in clinical trial performance. For example, understanding study site engagement enables study teams to optimize monitoring efforts to improve data cleaning efficiencies and lessen pre-inherited study risks (i.e., country and cultural differences, site technological capabilities, type of monitoring efforts, country CRO performance, etc.), and boost enrollment outcomes.

Clinical trial patient retention and dropout continues to be an issue amongst biopharmaceutical sponsors, as patient dropouts minimize the statistical power of clinical trial data, requiring study teams to enroll additional patients. This outcome not only expends project management and patient enrollment resources, but also causes study timeline slippage, and increases the costs associated with developing additional investigational medical product.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information concerning the establishment and operation of clinical trial data monitoring committees.