• By ICR Secretariat
  • Posted Saturday, January 27, 2018

Clinical Trial Deaths - Will Clearer Informed Consent Documents Be Enough?


'In October 2017, the watchdog group Center for Responsible Science (CRS), along with clinical trial participants and the father of a deceased trial participant, grabbed headlines when it filed a lawsuit against the FDA. The suit takes aim at informed consent regulations, seeking to ensure that potential trial participants receive sufficient information to truly evaluate the risks and benefits of participating in a drug trial.

Will the lawsuit be successful? What steps do clinical trial stakeholders — drug companies, regulators, investigators, and others — need to take to improve the informed consent process and ultimately make trials safer for patients? For answers to these and related questions, Clinical Leader turned to David Rosen, co-chair of the life science practice at Foley & Lardner and a 14-year veteran of the FDA.'

To read the full interview, click here or follow the link above.