- There are some interesting startups, e.g. https://presentient.com/ , who predict whether a clinical trial is going to pass or fail, earlier in its process. This allows you to stop failing trials sooner, thus saving money and redirecting resources to other trials; and to stop succeeding trials sooner so that you can bring drugs to market faster.
- Expanding challenge trials (where you allow people to opt in to have early stage drugs tested on them) is one other way to get trial data much faster.
- Looking at ways to increase patient recruitment for clinical trials. This is one of the main causes of trial delays.
- In addition to Australia, companies are making great use of running trials in Eastern Europe. Poland and Georgia are two that I'm aware of, where trials can be run significantly faster and cheaper, whilst still having ethics reviews, etc. More countries allowing this to happen will increase clinical trial speed.
You didn't explain why slight improvements in drugs take longer. That is primarily because you have to test the new drug with the approved drug as a comparator. The differences in improvements are expected to be small and therefore larger numbers of subjects in the treatment arms will be necessary. The trial will generally take longer to enroll and longer to reach a primary endpoint. Safety testing always requires time as well.
Great episode! Just wanted to clarify that the US does have a federal Right to Try Act, signed into law in 2018. It allows physicians to request experimental drugs directly from manufacturers (without FDA approval), on behalf of a patient with a life-threatening condition who has exhausted approved treatments. There's also the FDA's Expanded Access (or Compassionate Use) program, which works similarly but includes FDA oversight. The Montana example you raised is really interesting, as it significantly expanded their Right To Try law to cover any condition, not just terminal illnesses. Thanks for covering this topic!
could third world countries get good at organizing clinical trials as a way of getting themselves into the pharmaceutical supply chain?
there is lots of TB in Latin American prisons. should Latin American countries organize clinical trials among prison populations?
this episode was so cool. how do I find a text transcript? may I translate it for a Spanish-language pamphlet series and the Andes Review of Books web site that I mean to vibecode?
Some additional ideas to throw into the mix:
- There are some interesting startups, e.g. https://presentient.com/ , who predict whether a clinical trial is going to pass or fail, earlier in its process. This allows you to stop failing trials sooner, thus saving money and redirecting resources to other trials; and to stop succeeding trials sooner so that you can bring drugs to market faster.
- Expanding challenge trials (where you allow people to opt in to have early stage drugs tested on them) is one other way to get trial data much faster.
- Looking at ways to increase patient recruitment for clinical trials. This is one of the main causes of trial delays.
- In addition to Australia, companies are making great use of running trials in Eastern Europe. Poland and Georgia are two that I'm aware of, where trials can be run significantly faster and cheaper, whilst still having ethics reviews, etc. More countries allowing this to happen will increase clinical trial speed.
You didn't explain why slight improvements in drugs take longer. That is primarily because you have to test the new drug with the approved drug as a comparator. The differences in improvements are expected to be small and therefore larger numbers of subjects in the treatment arms will be necessary. The trial will generally take longer to enroll and longer to reach a primary endpoint. Safety testing always requires time as well.
Great episode! Just wanted to clarify that the US does have a federal Right to Try Act, signed into law in 2018. It allows physicians to request experimental drugs directly from manufacturers (without FDA approval), on behalf of a patient with a life-threatening condition who has exhausted approved treatments. There's also the FDA's Expanded Access (or Compassionate Use) program, which works similarly but includes FDA oversight. The Montana example you raised is really interesting, as it significantly expanded their Right To Try law to cover any condition, not just terminal illnesses. Thanks for covering this topic!
https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try
https://www.fda.gov/news-events/public-health-focus/expanded-access
could third world countries get good at organizing clinical trials as a way of getting themselves into the pharmaceutical supply chain?
there is lots of TB in Latin American prisons. should Latin American countries organize clinical trials among prison populations?
this episode was so cool. how do I find a text transcript? may I translate it for a Spanish-language pamphlet series and the Andes Review of Books web site that I mean to vibecode?
This podcast from a16z has some insights into how China has increased their clinical trial output.
https://overcast.fm/+ABNwV_N4VsA
Some good ideas in here, too, that can be replicated.