Decentralized Clinical Trials - How Steem can have unlimited growth potential

in steem •  29 days ago

SMT Proposal - Decentralized Clinical Trials

This blog post is to inspire people to think out of the box about what SMTs can do, what Steem (and only Steem at this time) can leverage, and how Steem can grow it's ecosystem. This growth in the Steem ecosystem in my opinion requires that Steem as a community strategically embrace science. The community will have to choose whether to use it's voting pool to reward scientific endeavors or funky memes. One problem in most societies and in the world in general is the extremely high cost of healthcare. A major reason for this high cost is due to the high cost associated with developing new treatments such as drugs.

Using an oracle model similar to the one @Ned highlighted it will be possible to leverage SMTs to develop new anti-aging supplements. Unlike with drugs which require FDA approval the supplement industry is a lot less strict. This would allow for the familiar ICO crowd funding model to be utilized in the manner I will list below:

  • Participants who volunteer to take part in the trial will receive tokens which represent a share in the profits from whatever drug or supplement is developed if the trial is successful. Just as with ICOs it should be expected that most trials will fail but if just one of these trials is a success then the participants could be well rewarded. In the case of failed trials then the world benefits from a better understanding of the science. All efforts should be taken to do trials which are of low risk to participants and a similar model is Lifespan.io. The problem with Lifespan.io is that it is a scam like model we a familiar with in Kickstarter where people "donate" in exchange for kudos. SMTs allow for much more than this.
  • By Leveraging SMTs there can be legally binding securities offered to participants in the trial. In essence the participants do not buy the securities but instead earn them by participating in the trial. Those who are not brave enough to participate can take the lower risk route of buying them without having to participate. This would allow even so called "unsophisticated"/poor participants to have access to opportunity.
  • Global trials allow for instant diversity and better data sets.
  • Decentralized would mean that in order to buy the supplements which result from the trial the world would be required to buy the SMT token which would function like a coupon or voucher. This would give the token value provided that the supplement has some measurably beneficial effect in the studies.
  • Marketing would be trivial because if any supplement works it will immediately go viral not only advertising the supplement but also Steem and crypto itself.
  • Because established companies aren't necessarily going to lead here it would allow for innovation from smaller companies. Companies involved for example with making cannabis related supplements will be able to conduct randomized control trials via the blockchain.
  • If SMTs can be securities then we would have the potential equivalent to a mini stock market on top of Steem. This could bring in trillions of funding via ICOs.
  • If SMTs can be securities then SMTs can pay dividends (in theory) provided that this functionality is added. This can be accomplished by using the burn function to destroy tokens or it can be done by creation of new tokens according to some profitability metrics (profit sharing algorithm).

How to achieve this?

That is up to the Steem community to figure out. I would suggest that Steem leverage it's social capital by relying on relationship science. That is to say that there is a science to it and there are ways for the Steem community to leverage it's current relationships to form mutually beneficial deals with various supplement and drug companies. For instance many of the cannabis companies, many of the anti-aging researchers, many of the supplement developers and geneticists are on Steem. There are doctors on Steem who have accounts and who may be in a position to leverage their knowledge for the mutual benefit of themselves and Steem.

References

  1. https://www.ctti-clinicaltrials.org/projects/decentralized-clinical-trials
  2. https://www.outsourcing-pharma.com/Article/2018/03/12/Novartis-Decentralized-trials-could-expand-enterprise-around-the-world
  3. https://www.longecity.org/forum/topic/102207-trodusquemine-reverse-plaque-group-buy-share-data/?view=findpost&p=858026
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Nice post! I am training to become a pathologist, have a PhD in neuroscience and invested in several biotech companies (Nordic Nanovector, PCI etc.) and had similar thoughts as you for some time. It would probably be a very cost-efficient way to recruit for clinical trials. Also, if the patients have their data (for a particular disease) on the blockchain they will own it and have an upside if the token they get an ​ increase in value. I truly hope we can utilize the Steem blockchain to make this happen.

Interesting idea.
I am executing clinical trials by myself (not me but in a pharm company), so I would love to see some decentralization and generally innovations in this area. But there are some serious hurdles. E.g. incentivizing patients to participate in clinical trials is a no-go even more so, if their asset/pay is directly related to the outcome of the trial. This creates a huge bias. I think Ethic Committees would not approve such an approach. If you are going to areas where there is less scrutiny on proper study design, like food supplements, then the possibilities to earn your investments, are also much lower - unless you have a truely unique selling proposition (USP) which in turn is very hard to achieve no matter how you gather the patients into the trials. In any case you first need a good product candidate.

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But there are some serious hurdles. E.g. incentivizing patients to participate in clinical trials is a no-go even more so, if their asset/pay is directly related to the outcome of the trial. This creates a huge bias.

Wouldn't it depend on the nature of the trial? For example if we rely on biomarkers for aging in the form of blood test results then really of course patients are going to be biased to want the best health possible but it doesn't mean the treatment is going to change their blood test results. For example if their hsCRP goes down after taking a specific drug or supplement and this is documented via official health records on the blockchain then the numbers speak for themselves. Where does bias play a role?

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In most trials adverse events are collected. If the patient´s stake is related to the study outcome, he may under-report any side effects. The blood test example you described is free of this bias, yes, but those lab tests are only part of the game, side effects and PROs (patient related outcomes) would be heavily biased.

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This is true for safety studies but suppose the safety studies already happened and we know side effects are limited but we do not know for example whether or not a drug has a beneficial impact on the biological markers of human aging?

It is true under strict FDA rules there could be problems. This is actually a problem with the FDA not adapting to the technology though. The FDA could update themselves to function in a decentralized context.

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I think Ethic Committees would not approve such an approach.

Unfortunately you are probably right which is why the FDA approach shouldn't be the first approach. The supplement route should come first and then later once the process is refined then go the FDA approach. I do think it is possible to remove at least some of the bias.

For one you don't have to reveal to the patients the study results or certain details. Wouldn't this remove the potential for bias if the patients don't have enough knowledge to form a bias? The patient for example could have no way to know success or failure of a trial unless they are told. Would this also raise ethical concerns?

Patients for example currently get paid to participate in trials. If they are paid now, does this not introduce a bias too? A bias in the type of patients who might desire to participate in clinical trials for instance?

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Yes, patients are paid currently and this is not free of concerns! It is a careful balance of getting patients in studies (without it much slower improvements in medicine) and not overpaying to increase the risks for patients who otherwise would constantly be in trials.
And yes, already today this creates a bias, as paid patients do not represent the whole population, but the patient population consists of more people who need the money, i.e. represents socially weaker populations.
But by paying more if the study result is better, the bias gets much more severe.
Of course during the study they would not know the results, same like the study investigators. But as mentioned, due to the pay incentive they would behave differently during the study and by this create the study result (e.g. less side effects, nicer QOL questionnaire scores).

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I don't suggest we pay more if the study results are better but I do see the concern if the participant in the study somehow could have great financial gain if the study is successful. This is also true though of the researchers conducting the study who want to patent a drug so how are the researchers not also participants who could bias the study in some way? It is delicate.

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Typically it is not that black and white and a single study is not enough to get a product through approvals. Plus onyly after statistical analysis one knows the results. Besides in pivotal phaseIII studies you have a randomized double-blind setting with multiple sites participating, where the influence of a single investigator is quite limited. Plus those studies are audited/inspected by Authorities (yes, FDA reps go to random sites and check all the study files plus the source data), but by the Sponsor as well (who has no interest in faking by some investigators, as the validitiy of the whole study is at stake.) This makes the studies so expensive, by the way, and thus the drugs. Even FDA is concerned that the regulations make the studies too expensive, this tells a lot. But that´s another story.
But in simpler food supplement studies where single site-studies are possible of course there is always a risk. That´s also one of the reasons why so many products are on the market who offer nothing but the placedo-effect (which is of course better than nothing and supports self-healing).

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good product candidate.

These already exist. For example Red Yeast Rice functions a lot like a Statin. Many food supplements have been shown to have medicinal properties. I don't think there is a shortage of people who are willing to buy supplements. I do think the FDA is strict but then it's global so unless the FDA plans to enforce all around the world how does the centralized ethics committee and FDA stop people in the random countries from doing science? They can stop it in the US though.

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In most countries there are ECs, MoH or other Authorities who are no less restrictive than the FDA. But agreed, for such candidates you mentioned, a decenrtalized approach could work, if safety isn´t a topic, and you can design the study to avoid any reporting bias.

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I am following you here...the ideas are unlimited truly