I’m at a remarkable conference at the University of Minnesota, http://closingthegapnow.org/index.php/agenda/. Kudos to John Morrissey for bringing this group together, and thank you, John, for inviting me to speak.
The conference challenges the conventional wisdom that new cancer drugs that show promise in Phase 1 trials must be further evaluated through large phase 2 and 3 studies.
One problem in finding innovative approaches to cancer is the inertia of federal regulatory agencies, including FDA and OHRP. Their circumstances are not quite the same, however.
FDA is solidly entrenched and widely known as the agency that will have control over what new drugs, devices, and biologics can be marketed. We hope that FDA will become more open to new ways of demonstrating therapeutic effectiveness apart from classic randomized controlled trials.
OHRP is in a more tenuous situation. Its name is unknown outside the research community. We know today that the regulatory approach of OHRP, and the IRB process that it oversees, has failed. The sooner everyone involved realizes this, the better.
This audio is of the 13 minute talk I gave on the problems with regulation under OHRP and the possible solutions. It’s a live recording, please forgive the occasional rattle of silverware and coffee cups.
I mention Brittany Madden, the young woman, suffering from incurable brain cancer, who moved to Oregon in order to be able to get medical help in hastening her death at the time she chose. It’s a heartbreaking story. We should be doing more to find answers to brain cancer and other serious diseases, and less to regulate (and slow) the scientists who can find those answers.