Crowdunding and Contract Research Organizations (CROs)
There has been a lot of talk about crowdfunding... and there has been a lot of group buys to test certain chemicals... What I've found is that we never get any real conclusive evidence from these group buys... If i have to read another review that says:
1. "my shedding has stopped, I think?"
2. "I think I see some vellus hairs by my hairline-- but I'm not sure if they are new or just hairs that are miniaturizing"
I mean, guys, come on. We're making honest attempts but the results of our efforts are laughable. Zero tangible proof.
My Proposition:
We may be better off putting together a foundation that can crowdfund and then hire offshore CROs to run our trials for us....
What is a CRO? A contract research organization:
A contract research organization (CRO) is an organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance. CROs also support foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH, EMEA, etc.).[1]
Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices.[2] CROs range from large, international full-service organizations to small, niche specialty groups.
CROs that specialize in clinical-trials services can offer their clients the expertise of moving a new drug or device from its conception to FDA/EMA marketing approval, without the drug sponsor having to maintain a staff for these services.[3]
(source: http://en.wikipedia....h_organization)
Costs between $20,000- $40,000 if you use a foreign company.... and many of the countries may not recognize IP--- so we can test patented chemicals maybe?
Here is an interesting Quora question and then an answer:
How much does it cost to do a very small investigational clinical trial of a nonprescription supplement?
I've got an idea that has some reasonable theoretical and clinical evidence to warrant further investigation. How much would running a small (say 10-30 participants) open-label clinical trial cost? Note that this this compound is already available OTC, and the application would not require FDA-approval, and the trial would only serve as the basis for the decision to fund a further placebo-controlled study. Basically how much will it cost for me to decide whether this is worth pursuing or not? Are there any standard metrics? It would be a short term (say 6 week) clinical trial with just a few outcome measures.
ANSWER:
Marc Lemay, Twelve years of dietary supplement development. Certified Clinical Trials Investigator by Association of Clinical Trials Professionals. Carried out over a dozen IRB-approved controlled clinical in the US and Korea. http://marclemay.brandyourself.com/
In the first scene of Saturday Night Fever, Tony Manero’s walking down the street to the Bee Gees’ Staying Alive, and the lyric goes something like “Well, you can tell by the way I use my walk, I’m a woman’s man, no time to talk.” The walk, by John Travolta, has got a certain style. You need style. You’re on the hunt. You’ve spotted an opportunity. You’re not sure how to proceed.
You say you’re thinking about an OTC, and that the application wouldn’t require FDA approval. But FDA does regulate claims relating to OTCs, so maybe you’re thinking about an off-label indication - not an approved claim, but just a new use of a drug that’s approved for something else. If you’re a physician yourself, this might work for your own practice, and for word-of-mouth campaign - if this works out, you could tell your colleagues about it, but chances are you won’t affect medical practice all that much beyond your own little (or large) office.
You’re on the right track, Tony. You’re in the pocket, now follow through. What you need is a pilot study. Not a fake pilot study that’s never followed by a full-on clinical, but a real pilot study, which means a feasibility study.
A pilot study isn’t designed to produce statistically significant results. Most times it can’t be, because you don’t know the magnitude of the effect your experimental treatment might have. What you do know, though, or if you don’t you must define before you start, is the smallest clinically significant difference on some measure. Say you’re dealing with “resilience” in seniors, and you find that a Six-Minute Walk Test has been generally accepted as a good global measure that. You’d pore over the literature on that test and on resilience to identify a generally accepted smallest measure that means anything to anybody. It might be 12 meters over a 6-minute standardized walk. Below that, it means nothing. That or more, it might mean something to somebody. In real life. Outside statistical analyses.
Then you do a gut check whether your old dog’s new trick can live up to that standard. If yes, proceed to a pilot study. If there are any subjective measures involved, a blinded, placebo-controlled design is essential. If there are only biological measures involved, you can start with an open-label study. I’d say 10 or 20 subjects at most would be enough.
Review and approval by an IRB is essential, as are contract clinical sites. Fees vary. You might pay $75 per subject for Informed Consent, $75 for Medical and Medication History, $125 for a Physical Exam, $20 for a questionnaire, $40 for a vitamin B6 assay, $14 for a serum chemistry panel, $15 for hematology, CBC, and urine analysis, $10 for a pregnancy test, $150 for a coordinator, $45 for the investigator, $150 for the subject, $20 for parking, and $89 for screen fails; repeat most of that for a single follow-up visit, add a 20% overhead, $3,500 of non-refundable startup fees, $1,000 for recruitment ads, $1,800 for IRB review, $500 for the IRB writing the consent form for you (highly recommended), and you come up to $38,672 for 20 subjects. The same simple study would set you back $105,416 for 60 subjects.
Once you’ve done that, it’s a straightforward matter to perform a power analysis to find out how many subjects you would need to show a difference between placebo and active treatment that’s as least as large as the smallest clinically meaningful difference.
No control, so-called “pilot studies” (so-called because they’re not followed up with a larger study) can also be useful if on the face of it they provide useful guidance to practice. As a case a point, the small study by Dr. David Matlock (http://www.acep.org/content.aspx...) of Illinois Colllege of Medicine at Peoria, who found that listening to Staying Alive while being trained in CPR helped doctors and medical students keep a good pace of chest comprehensions when they were retested five weeks later.
On the other hand you might not need a clinical trial at all man, relax. It’s a tough business. It’s for the big Pharma boys. Have you heard of the failure rate in clinical trials? It’s scrotum-tighteningly high. Clinical trials aren’t the answer for nutrient studies (http://www.ajcn.org/content/62/6...), nor, I imagine, for many OTCs.
But if that’s what you really want - if it’s deep in your heart, and just has to come out - if you hope to be understood and believed in this crazy world, you can do worse that grok the Consort statement. (http://www.consort-statement.org...) There’s nothing sadder than wasted effort. It happens all the times clinical trials. Just conform, for once in your life, follow the rules, and you’ll do better.
If you’re feeling like you’re ready for the Big Time, you might step up to double controls: placebo and active. So many fools try to make their offerings shine by comparing it to - nothing. Compare your stuff to the best that’s out there, come on and strut. Who cares what anything does against placebo, really? It’s how it stacks up compared to the best approved therapy that counts. (http://www.nejm.org/doi/full/10....)
But I’m a gonna try one last time to talk you down. Do you really need a clinical? Let me tell you a story about the “test everything forever” mentality. That initial, uncontrolled, fun study by Dr. Matlock that suggested Staying Alive can help you perform good CPR was replicated in a more rigorously designed study. (http://emj.bmj.com/content/early...) And what did they find? Lo and behold, controlled scientific research showed that people performing CPR with disco songs in mind sort of kept to the right time, but not to the right depth - they didn’t push hard enough. This team actually performed two controlled studies on this topic, and this was the second messy, disappointing result - good beat, wrong depth. Conclusion? “This interesting but unproductive area of resuscitation research should be discontinued”; though the lead author of the study did admit, "Any form of CPR is better than none at all.”
So: first, open, uncontrolled study: Staying Alive can help you save a life. Second and third, serious, controlled studies: actually, disco music doesn’t help with compression depth (though it does help with the beat). So give it up. One of those researchers mentioned that there are CPR apps now that can give you a variety of cues to maintain correct compression rhythm and depth. That’s just bonkers.
I don’t care if you got the CPR app on the home menu of your iPhone 4Smother****er, if I drop to the floor with my heart stopped, you gonna call 911 or call yourself if you have to, then push hard to the beat of Staying Alive. You know Mr. Chow from that eye-wateringly funny The Hangover movie? Well Mr. Chow is played by Dr. Ken Jeong, who recently launched a brilliant campaign with the American Heart Association promoting the use of Staying Alive. (http://www.youtube.com/americanh...) What’s the American Heart Associations’s answer to the problem of people not pushing hard enough in those previous studies? Was it, “further research is needed”? Screw that. It’s two women in well filled-out t-shirts rushing into the room. On those t-shirts - staring at your eyeballs - are two clear as a bell instructions: 1. Call 911. 2. Push hard and fast. Cue Dr. Jeong dancing. Push hard and fast, you can do it, it's not complicated! Not “more research”! Not “this interesting but unproductive area of resucitation research should be discontinued.” Whose approach saves more lives? Whose approach serves Life? Ultimately, that’s what you’ve got to decide: who is this for? It has to really help people somehow. That’s the only point of doing clinical trials. For already approved drugs, beware the waste of immense effort and time for minuscule bits of knowledge.
Good luck!
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