A note—I’ve deleted a confusing post that some completely misinterpreted about vaccine—we absolutely need Phase 3 trial—I was advocating for compassionate expansion of P3 vaccine enrollment to people in hotspots. I was clear further down a thread but the beginning was murky.
2) I reiterate my previous recap: Expand vaccine via Phase 3 trial expansion to eligible people volunteering for early access in hotspot epidemic areas as part of Phase 3. We are NOT SKIPPING PHASE 3 trial. There’s still randomization in expanded trial access. Don’t misinterpret
3) some argue compassionate use is only for end of life cancer care. But we don’t just have 1 case w/ imminent death—we have thousands. 1200-1400 per day dying in US alone. Expanding P3 trial enrollment in hotspot areas could have a huge impact now even if 50/50 randomization.
4) And there are so many people at risk. Kids, grandparents, people who have obesity diabetes heart disease and more. And risks are not just death, but also long term illness. That’s why we need more trial participation. I used to even study race & trials: pubmed.ncbi.nlm.nih.gov/18204365/
5) In world of clinical trials, diversity of inclusion—giving opportunities for people to join trials is important for health equity & social justice. Reducing barriers to join is critical. Often trials rarely ever reach minority groups. Trial expansion was my main message & goal
6) Here is another trial participation research paper I did - first author- on gender disparities in willingness to participate in trials. I did this analysis at Johns Hopkins. I can’t emphasize enough how important improving participation in trials is. jamanetwork.com/journals/jamai…
7) Bottomline: one of the best ways to help improve population health is to enroll more folks in trials—as diverse inclusion as possible to benefit more people & populations they come from. Expanding Phase 3 trial enrollment for more people helps that. Thanks for listening.
8) End of the day: always err on the side of compassion and empathy. That’s what I learned and was taught as fundamental moral lesson. Now we need compassion for those suffering who cannot work from home or afford private tutors or food for that matter. For those helpless, i cry.
9) I got to sleep with nightmares about the deaths around the world. I cant get them out of my head. There is no easy answer to any of this. So senseless we have such lack of national leadership.
