If you enter Health Nucleus, a new facility in San Diego confounded by J. Craig Venter, one of the world’s best-known living scientists, you will get a telling glimpse into the state of medical science in 2015. (STAT)
Are Internet-based studies the future of clinical research?
Are Internet-based studies the future of clinical research? “…as technologies that allow data collection and at-home lab tests improve and become more widespread, the rise of online clinical trials may provide more opportunities for researchers to conduct more inclusive studies, and to help patients overcome some of these common barriers to participation.” (Jerry Matczak, LillyPad 10/29/14)
FDA Docket. Using technologies and innovative methods to conduct Food and Drug Administration-. Oct 2015
Using Technologies and Innovative Methods to Conduct Food and Drug Administration – Regulated Clinical Investigations of Investigational Drugs; Establishment of a Public Docket. Food and Drug Administration, Health and Human Services. October 29, 2015
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a public docket to solicit input from a broad group of stakeholders on the scope and direction of the use of technologies and innovative methods in the conduct of clinical investigations.
5 problems with using spreadsheets to collect clinical data
Spreadsheets are too basic of a tool to keep up with the increasing complexity of clinical trials. Here are 5 reasons to stop using them. (Kristina Lopiensky, ForteResearch.com)
FDA seeks info on new tech helping conduct clinical research
The U.S. Food and Drug Administration (FDA) on Wednesday announced it’s looking for more information on technologies and innovative ways to more efficiently conduct clinical research. The use of smartphones and tablet devices to collect trial participant data seems to be of particular interest to FDA as it’s requesting more information on the challenges associated with collecting data on trial participants’ own devices, which FDA says may be used to access and respond to study-related questionnaires. (Zachary Brennan, Regulatory Focus)
FDA Guidance. Product Development Under the Animal Rule
Product Development Under the Animal Rule. October 27, 2015. Final. CDER
FDA Guidance. Integrated Summary of Effectiveness
Integrated Summary of Effectiveness. Final. October 7, 2015. CDER
FDA Guidance. Brief Summary and Adequate Directions for Use
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs. August 5, 2015. Draft, Revision II. Advertising.