Newsletter - January 12, 2023
FDA Brass Seems to Suggest US-Only Clinical Trials: Is it Practical or Fair?
At the JPM conference this week, the FDA commissioner stated that he is “100% opposed to offshoring” of clinical trials, basically against sponsors going to other countries for cost savings. This is perhaps one of most myopic views expressed by someone so senior at FDA for many reasons. To be fair, I was not at the conference...Read More
Can Paying More to Participants Increase Diversity in Clinical Trials?
A recent academic study found, surprisingly (pun intended), that paying people $500 to participate in a study that involved shipping self-collected blood samples to a lab and answering a short questionnaire, led to almost everybody participating compared to when no compensation was offered. The authors concluded that by offering...Read More
FDA Brass Seems to Suggest US-Only Clinical Trials: Is it Practical or Fair?
At the JPM conference this week, the FDA commissioner stated that he is “100% opposed to offshoring” of clinical trials, basically against sponsors going to other countries for cost savings. This is perhaps one of most myopic views expressed by someone so senior at FDA for many reasons. To be fair, I was not at the conference...Read More
Can Paying More to Participants Increase Diversity in Clinical Trials?
A recent academic study found, surprisingly (pun intended), that paying people $500 to participate in a study that involved shipping self-collected blood samples to a lab and answering a short questionnaire, led to almost everybody participating compared to when no compensation was offered. The authors concluded that by offering...Read More
