Alternatives to clinical trials

NickOttens

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?

NickOttens

@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.

Roey

I wonder whether we should consider experiments in large mammals (dogs, sheep, pigs, etc.) with the intent to demonstrate age reversal and rejuvenation effects.

Jozef

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.

NickOttens

@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?

Jozef

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? :)

mashizaq

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.

Jozef

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

Lodder545

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/

NickOttens

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?

dives86

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

NickOttens

@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?

pscheck

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.

Janetlee

the only way you're going to get longevity and reverse of Aging is through autophagy and the body creating new cells. this is a natural process that occurs most particularly during sleep and with intermittent fasting so that the body can use its own, efficient and reliable method. Autophagy is the body's way of cleaning out damaged cells, in order to regenerate newer, healthier cells, according to Priya Khorana, PhD, in nutrition education from Columbia University. “Auto” means self and “phagy” means eat. So the literal meaning of autophagy is “self-eating.” The fasting and results are optimally measured in labs, but we have lots of evidence of people using this fasting method with impressive results recorded both as anecdotal evidence and with reporting to medical professionals. Autophagy is the natural, regulated mechanism of the cell that removes unnecessary or disfunctional components. It allows the orderly degradation and recycling of cellular components. Three forms of autophagy are commonly described: macroautophagy, microautophagy, and chaperone-mediated autophagy. Many clinical trials already exist for this as bases for further work, and just knowing the insulin spiking issues from each time a person eats as well as for some cultures, deleting most carbohydrates, especially processed foods from the diet,would unfold into greater understanding and access to health and longevity. The body regenerates only when it can do so, and fasting allows the body to focus on autophagy instead of digesting foods.