Alternatives to clinical trials

NickOttensNickOttens Community ManagerBarcelona, SpainPosts: 798 admin
Clinical trials may need to be a part of this competition (see @Roey's questions about clinical trials), but there would be challenges related to costs, regulatory approval, timeline, and the ability to compete.

If we didn't want to do clinical trials, what would be the best alternative for an XPRIZE Age Reversal?

Comments

  • NickOttensNickOttens Community Manager Barcelona, SpainPosts: 798 admin
    @barryflanary, @CarolynPorter, @MariaEntraigues, @nfmanagement, @stroykova, @Terenceericson, do you have suggestions for us? If we decided against including clinical trials and in a longevity XPRIZE, what would be the best alternative?

    We're designing a competition that will catalyze innovation in age reversal, inspire the public, and spur investment in longevity. We'd be grateful for your feedback! Click here to learn more about the prize design and here to explore other discussions.
  • RoeyRoey Posts: 157 XPRIZE
    I wonder whether we should consider experiments in large mammals (dogs, sheep, pigs, etc.) with the intent to demonstrate age reversal and rejuvenation effects.
  • JozefJozef Mr. Posts: 4
    edited July 26
    Alternative is to run biological system in computer simulation. Number of initial issues arise and it will require huge computational power. Here is the example what remotely touches the idea: https://youtu.be/makaJpLvbow
    . I belive limited set of simple equations can spin such physical computer simulation to mimic biological system.
  • NickOttensNickOttens Community Manager Barcelona, SpainPosts: 798 admin
    @ahessel, @Assaf_Horowitz, @Lodder545 and @TSeoh, you may have suggestions for us here. We're currently designing our first longevity XPRIZE (background here) and wondering if clinical trials will have to be a part of it. What are the alternatives?

    Computer simulations and testing on large mammals have been suggested.

    Is either feasible? What other options are there if we want to significantly move this field forward?
  • JozefJozef Mr. Posts: 4
    It is feasible I believe. Mastery in quantum physics, chemistry and biology will be required by those building it. It all can be broken into small parts to start with. Brainstorm with me? :)
  • mashizaqmashizaq FOUNDER Posts: 10
    There is nothing wrong with clinical trials. Several similar studies done have clinical trials done and have proven to work. Also, I know we will have several individual offering themselves as test subjects, including myself.
    Anyway, for the purpose of answering the question thus adding to the level of knowledge based on our design, I think we can make use of registries.
    Registries are population-based cross-sectional or longitudinal observational data. High quality data require directions and uniform standards for diagnostics and follow-up. Registries with high quality data will usually not
    fulfill the legal criteria of a non-interventional study (NIS).
    Given the different objectives registries and clinical trials complement each others but should not be considered as alternatives.
  • JozefJozef Mr. Posts: 4
    Clinical studies are expensive, yet reliable. Better to spend resources on small team to create simulation environment. Once it will prove reliable, it can help in other xprize competitions too. Basically it will create industry of its own. #vision
  • Lodder545Lodder545 Posts: 5 ✭✭
    Per the Code of Federal Regulations TITLE 21--FOOD AND DRUGS, CHAPTER I--FOOD AND DRUG ADMINISTRATION, if a product claims to diagnose, mitigate, treat, cure, or prevent disease, it's a drug that will require clinical trials.
    Whether aging is a disease or not remains a matter of debate. See for example
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6057778/
    and
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4471741/
  • NickOttensNickOttens Community Manager Barcelona, SpainPosts: 798 admin
    Thank you all for your sharing your thoughts!

    @Alexandra, @Steve_Liebich, @iraspastor, @dives86, @ross_d_king, @Wei, I'd like to ask your opinion as well. What do you think is the best alternative to clinical trials for a longevity XPRIZE?
  • dives86dives86 Posts: 2
    Hi Nick, I think the use of a conserved or multi-species ageing biomarker, which optimises for both accuracy and translatability, would be a good idea. This would give people the flexibility to modulate ageing in their chosen system (e.g. in vitro, mouse, small-mammal) with a more clinically relevant readout. Bernardo Lemos has a multi-species ageing biomarker based on rDNA methylation https://bit.ly/2D19YP6 and Steve Horvath has an upcoming 'mammalian clock' spanning a huge number of species
  • NickOttensNickOttens Community Manager Barcelona, SpainPosts: 798 admin
    @pscheck, @Wally, @mkaeberlein, what would be your recommendation? If we decided against including clinical trials in an age-reversal competition, what would be the best alternative?
  • pscheckpscheck Associate Professor Posts: 2
    I think the best one would we a lowering of mortality, essentially a mortality curve or a chorot of aged animals that declines for a while reaching the level of younger animals. That would be unequivocal evidence for rejunvenation. However, that is an extraordinary high bar to clear, both experimentally and in terms of cost of the experiment.
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