By Zachary Shapiro Hello from the Post-Trial Responsibilities conference! I will be live blogging session 2: where speakers will be providing important perspectives on PTA. Barbra Bierer is monitoring the discussion. We started with Richard Klein calling in from FDA: Richard is talking about post-trial responsibilities. He points out that there is a justice issue…
Post-Trial Responsibilities: Ethics and Implementation Thursday, September 18, 2014 7:30 AM – 5:30 PM Wasserstein Hall, Milstein East AB, Harvard Law School, 1585 Massachusetts Ave. The conference is free and open to the public, but due to limited seating, registration is required to attend. Please register here. The term “post-trial access” is used broadly to connote a wide range…
By Zachary Shapiro Post-Trial Access (PTA) is emerging as an important topic in the design of ethical clinical trial protocols. PTA refers to the provision of study drug to the participants in a successful clinical trial (and maybe others) during the crucial period after a clinical trial phase is over, but before the drug is…
Post-Trial Responsibilities: Ethics and Implementation Thursday, September 18, 2014 7:30 AM – 5:30 PM Wasserstein Hall, Milstein East AB, Harvard Law School, 1585 Massachusetts Ave. The conference is free and open to the public, but due to limited seating, registration is required to attend. Please register here. The term “post-trial access” is used broadly to…
