Wondering if electronic informed consent is right for your clinical research study? My 2-part series will help you answer that question. Mitchell Parrish of Quorum IRB recently led a webinar about electronic informed consent, which included discussion of regulatory and other considerations. In this series, I summarize the information presented by Parrish, as well as […]
Electronic Informed Consent: Possibilities, Benefits, and Challenges
The clinical research community is showing greater interest in electronic informed consent. And they should. Electronic consenting offers benefits that traditional paper-based consenting does not. But with electronic consenting technology comes new complexity. To address the regulatory and IRB complexity of electronic consenting, Quorum Review IRB recently hosted a webinar presented by Mitchell Parrish. In […]
The Best Rebar Interactive Blog Posts of 2011
Thank you for a great year. I’ve enjoyed your excellent feedback and discussion immensely, and I’m looking forward to much more in 2012. Best of luck in the new year, and I hope your 2012 is happy, productive, and prosperous. If you have suggestions for the Rebar Interactive blog or you would like to guest […]
FDA: Driving Biomedical Innovation?
It’s not often you see “FDA” and “innovation” in the same headline. But with the publication of a recent report, FDA is trying to change that perception. FDA Commissioner Margaret A. Hamburg, MD recently released a blueprint titled “Driving Biomedical Innovation: Initiatives for Improving Products for Patients” at the 3rd annual Washington Ideas Forum. The […]
Did Boehringer Just Take a Page Out of Apple’s Playbook?
Given the fervor Apple whips up over its products, you’d think each new device contained an app for spinning straw into gold and giving foot rubs. For this reason, Apple is widely known for its marketing prowess. Businesses of all sizes and industries study Apple’s marketing successes and attempt to emulate them. And there is […]
What Healthcare Reform Can Teach Us About Patient Recruitment
As I mentioned in my last post, I recently completed a certification in health information technology (HIT) and was struck by how many of the reform principles being used in the broader healthcare system could be applied to clinical trials. In that post I discussed why it is important that clinical trials systems be designed […]
Are Your Clinical Trial Systems Designed to Run Downhill?
Over the last several years, the American public has grown increasingly frustrated by the inefficiency and cost associated with the US healthcare system. In an effort to improve that system, the HITECH Act was enacted in 2009 to promote adoption and meaningful use of health information technology. Among other things, the HITECH Act allocated funding […]
Pfizer’s At-Home Clinical Trial and a Lingering Question
When Pfizer announced that it was conducting the first at-home clinical trial under an IND, I was initially skeptical, particularly with regard to issues of consent and safety. But over the last few weeks Craig Lipset of Pfizer has done an excellent job of answering questions in a variety of venues, effectively demonstrating the thoughtfulness […]
The Mobilization of Clinical Research
Depending on how closely you follow politics, you might remember that the Obama campaign used text messaging quite successfully in 2008. Most famously, the campaign used a text message to announce Obama’s VP pick to people that had previously opted to receive messages. In addition to building a lot of buzz, the announcement of VP […]
