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For a few years, hair loss victims have dreamt of quicker and cheaper scientific trials. I believe that we are actually shut within the US, and a few international locations have already streamlining the method.
A lot of firms by no means develop doubtlessly efficient hair progress merchandise because of the prohibitively costly prices and time concerned in rigorous scientific trials. Others find yourself ceasing trials mid-way via because of the lack of funding.
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Are Prolonged Clinical Trials on the way in which out?
According to CB Insights:
“Studies estimate that the clinical trial process — where new drugs are tested on patients before the FDA approves them — lasts 9 years.”
I’ve little question in any respect about this timeframe. For us hair loss victims, there have been quite a few hair loss firms which have made us await 10-15 years whereas going via intensive three-stage trials. I checklist most of these in a bit additional beneath.
If all the things goes completely, the three levels of scientific trials can hypothetically be accomplished in 5 years (plus one other yr for manufacturing, advertising and gross sales). However, in virtually all instances, this doesn’t appear to occur. Most delays are attributable to fundraising points after every stage of the trials. However, many delays simply seem to be intentional prolongation and inventory worth manipulations.
Faster Clinical Trials in Japan and the UK
In 2014, I wrote a put up on the pioneering initiative made by the Japanese authorities in fast tracking stem cell technologies in the regenerative medicine space. Their aging population cannot afford to wait ten plus years for new technologies to come to market. The new regulations would allow for significantly faster clinical trials.
A short time after the above news, HairClone’s CEO Paul Kemp told me that they were going to start their trials in the UK due to some favorable regulations regarding in-clinic early use. And just recently in March 2023, it was announced that Britain is set to overhaul scientific trial regulation to fast-track approvals.
“The move comes months after an industry report showed that the number of annual clinical trials started in Britain dropped by 41% between 2017 and 2021, posing a “clear and serious threat” to its status as a scientific analysis vacation spot.”
I additionally suspect that Kintor Pharmaceutical is seeing quicker scientific trial development in China in comparison with the US, though I’m not sure.
Covid-19 mRNA Vaccines Fast Tracking
The Covid-19 mRNA vaccines had been created, evaluated and authorized for emergency use in under a year. While mRNA vaccine analysis was already happening for a decade, this one yr timeframe was insane. Even contemplating the dimensions of the worldwide pandemic, I couldn’t imagine the pace with which all of this went down.
Even extra astounding was how shortly over 60 p.c of US residents accepted this new know-how into their our bodies. In my opinion, the yr 2021 represented the turning level in how a lot threat individuals and governments had been prepared to take in terms of new drug or vaccine improvement.
I believe the pace of recent drug associated scientific trials must enhance within the US within the close to future. Otherwise, different international locations will slowly come to dominate drug improvement. One approach wherein US trial pace will enhance is via decentralization.
AI and Faster Clinical Trials
With synthetic intelligence (AI) within the information each single day in 2023, it’s no shock that AI is predicted to considerably enhance the pace of scientific trials. Last yr, I wrote a put up on AI and Machine Learning for hair loss drug discovery. When it comes to trials, companies can use AI to rapidly digitize clinical-trial processes so they can complete studies faster. According to a 2022 Deloitte survey:
“76% of respondents are currently investing in AI for clinical development.”
AI may also assist in the recruitment, monitoring and retention of trial members. Including by way of the usage of wearable applied sciences and by way of distant videoconferencing and knowledge assortment. Also associated is the usage of big data and analytics in making scientific trials higher and quicker.
10-Year Clinical Trials within the Hair Loss World
In the hair loss world, we’ve got seen many examples of firms taking ten or extra years to complete scientific trials. In some instances, they even take ten years to get via Phase 2 trials, after which resolve to not transfer ahead.
Among essentially the most well-known examples of those irritating long-term scientific trial situations within the hair loss world embody the beneath. With few exceptions, most of those already failed or are prone to fail.
- Cosmo Pharma and its Breezula, which finally began Phase 3 clinical trials in 2023 after 10 years. The company changed its name and ownership structure in between. I am still hopeful that this androgen receptor (AR) targeting product will get released.
- The even slower and increasingly suspect Follica. They must have been at this for almost 15 years by now?
- And don’t even get me started on the 14 years we wasted following Histogen. It surprisingly folded after starting Phase 3 trials; then came back and went backwards to start Phase 1b trials (!); and then re-folded (!!). Hair loss sufferers are perhaps the most gullible group of people on earth.
- Samumed (now Biosplice) was supposed to be the miracle story in the entire world of dermatology. Their valuation levels reached astronomical levels. They even finished Phase 3 trials for their AGA product after a decade of being in the news. Including a cover story in Forbes starring their poker star CEO. Then the hair loss program folded.
- Replicel (Canada) and its partnership points with the a lot bigger Shiseido (Japan). I nonetheless have some hopes that Shiseido will come via with closing stage trials. But I’d not guess on this know-how coming to market anytime quickly.
- Dr. Takashi Tsuji and Riken (Japan)’s hair multiplication process. This was the only greatest disappointment for me since I began this weblog ten years in the past. But Dr. Tsuji isn’t out of the sport but and a beforehand introduced 2020 launch has now pushed ahead to 2026. By now they need to have been in Phase 3 trials, however persistent fundraising points have delayed Phase 1 human trials.
- After main overpromise and hype, the hair multiplication failures of each Aderans and Incerytex over a decade in the past.
- Follicum, which has come again once more from the lifeless. However, I and most different readers suspect that each one they may do is disappoint a second time.
- Setipiprant PGD2 antagonist. It was bought by Kythera in 2015, which in flip was bought by Allergan, which in flip was bought by AbbVie. Ultimately, the product by no means got here to market attributable to disappointing late stage trials. I still cannot get over this audio recording and the truth that it was by no means faraway from the web.
- Also of word is Aclaris Therapeutics, though they solely wasted 5 years of our time.
No Financial Sense in Getting FDA Approval
In many instances, firms with efficient hair loss merchandise don’t even attempt to start rigorous costly scientific trials in an effort to get FDA approval. i.e., they offer up even earlier than beginning. Even massive multinational drug producers are reluctant to go for it, together with for the 2 hottest hair loss merchandise (off-label use) in existence in the present day:
- The most egregious instance of that is GSK’s determination to not file for FDA approval to market its enlarged prostate (BPH) discount drug Avodart (dutasteride) for hair loss. To today, dutasteride is just authorized to deal with male sample hair loss in South Korea and Japan. Even although it has been confirmed to develop extra hair than Propecia (finasteride) in virtually all research that evaluate the 2.
- In all chance, blood stress drugs oral Minoxidil will never undergo clinical trials for hair loss. The profit margins are too low, even though the drug is getting rave reviews from doctors and patients when it comes to its hair growth effects.
The FDA Intentionally Allows this Grey Zone
Below is a great interview of Dr. Jerry Cooley by Dr. Robert Haber. The former elaborates on the slow progress of FDA approvals and the tough job at hand for the FDA. It faces pressures from each side to go slower versus faster.
Key Dr. Cooley quotes from from 12:27 and 13:00:
“I personally believe that the FDA intentionally allows this grey zone…they actuallly want doctors to do some innovation”.
The Cosmeceutical Route Shortcut
The recent hype surrounding the extremely rapid development and sale of CosmeRNA portends favorably towards new future hair growth products. If a company can get approval to market a new product as a cosmetic, it entirely escapes the clinical trial process.
Even more interesting is the fact that you do not need this approval beyond one country or region to get going. Bioneer is not allowed to sell its product in its home nation of South Korea, but can do so in the UK and EU.
YOLO Mentality and Risk Taking
In my opinion, young people are increasingly becoming risk takers. Part of this is due to the “You Only Live Once” (YOLO) mentality. This is amplified by social media and the emulation of various influencers.
On Instagram, I am amazed to see the countless people who go through various laser, injectable and chemical treatment procedures on their faces. Many are easily influenced by celebrities, TikTok and YouTube videos, and live treatment demos from clinics.
Even crazier is people who take part in various Group Buys via hair loss forums, Discords and Reddit. They often import drugs and chemicals from somewhat sketchy entities in China and Eastern Europe. DIY gene therapy is also a thing.
Where I reside in the US, marijuana legalization has led to tens of thousands of new customers (and bad drivers). Fentanyl overdose deaths hit new records every year in the US. And US retail drug prescriptions are also at a record high. Illegal online drug purchases are probably also hitting new records each year.
I am not trying to promote doom and gloom. It just seems like people are willing to experiment with what they ingest or inject into their bodies far more often than ever in history. And I almost forgot: global hair transplant surgery totals also hit a new record last year. Probably the same trend with many other cosmetic procedures.
Clinical Trials: In Reality, there are 8 Stages
When I asked ChatGPT to give me the various stages of the clinical trial process, it gave me the below list of 8 steps. I have not even tried to check if all of the below is true to the dot, but it looks accurate. It is quite clear that the current clinical trial process is antiquated by the standards and expectations of the modern age.
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