Vedic Lifesciences

If your primary is not significant then your secondary is going to be a lot weaker. If 1 secondary endpoint has super significant results then instead of harping on that, a new study to double-check is ideal. The study population is selected with the primary endpoint in mind. Hence the selection criteria of the study population may not always match the secondary endpoints. Hence if something significant is seen in any of the secondary endpoints, a larger study should be planned to confirm the same.

There is not much of a difference between the two. In most cases, ‘Clinically proven” means when the primary endpoint shows clinical significance. However, the 'tested' term may not signify if the product has positive results, which can be justified by the term 'proven'

YES, there is a difference. If there is a “MAY” that means the quality or the quantity of clinical evidence to substantiate the claim is not sufficient. “DOES” is a really strong word in our industry so rather stick to “MAY” because you’re communicating to the consumer anyway. People are individuals and what might work for 1 person may not work for another person. Using “MAY” is more truthful and probably might not get you in trouble. “DOES” is a pretty significant claim and if you look at the FDA Qualified Health Claims it might be like this product may help reducing cholesterol but more research may be needed. We need to stop trying to be drug companies. “DOES” is more like a drug claim. 200 mg Ibuprofen DOES take the headache away. We are talking about nutritional support so we need to stop trying to be so definitive. This is also what law firms or attorneys would recommend lowering the risk.

It really depends on whether you have achieved significant levels and if the context is right. Maybe you have previous data which correlates. No endpoint is in isolation. There are so many endpoints that come together to build the whole story. So yes a secondary endpoint can also support a structure-function claim but one has to look at the totality of the evidence. One needs to think about whether the claim is related to the secondary outcome measure. Is it truthful enough and not misleading? An example would be having a population with knee pain in the study then all other outcome measures like QOL, flexibility, etc become secondary. If any of these outcome measures show a significant p-value of <0.0.5 then those structure-function claims can be made. 

Just because it works on one person doesn’t mean it’s going to work on another person. John said that it only gives information for clinical trial design. JC agreed and mentioned that he encourages all his customers to source evidence from anecdotal experiences for clinical trial design.
Vedic example: We did a study in which the sponsor himself had experienced benefits from the product before hence he had the belief in it. The study on 50 subjects proved him right.

Yes, let's take an example of doing a study on 90 mg of Vitamin C and selling 20 mg of it with the same claim. Not only is the concentration important but so is the dosage, regimen and duration of the study. If your study is only 7 days you cant market the product for many months because there is no safety data beyond 7 days. One can also do a study with multiple doses. Many times in our industry, people combine ingredients and claim synergy, so shouldn’t the synergy be proven in itself through a clinical trial? In this case, the synergy is very difficult to prove and is complicated. Many supplements have proprietary blends and individual extracts are present in small quantities. As long as there are efficacious ingredients in there, its ok to make a claim but not a synergistic claim. FTC may ask you to prove synergy which can only be proven through a study of individual ingredients and then a combination of the two. The combination should of course provide better effects. Each ingredient in the formula should ideally be individually tested and clinically proven, since as an industry we haven’t reached the stage of proving synergy yet. Vedic is running dose finding studies in which different doses of the same product are compared against baseline and placebo. 

Usually studies are done to support marketing and branding. There’s nothing wrong in doing more and more studies to improve your data. Brands are usually supported by clinical trials. CTs should not be done “out of fear” or from a regulatory stand point. They should be done from a marketing stand point or for a story telling opportunity. It’s amazing how a lot of people miss that. CTs are a great way to present your product to your consumer or B2B customer. Go ahead and present your business case to your team and make it sound like a great ROI on business expenditure. When you start selling a product based on anecdotal evidence then customers start asking you about clinical trials which is when you need one. On the basis of results in the secondary endpoints, you may do more studies. Sometimes secondary endpoint results can be surprising and unexpected. We often do studies after the product has already been launched into the market. It may even already have testimonials on the website. The studies are done as confirmation of safety and efficacy. They are often followed up by other endpoint studies for different health claims on the same product.

This is from a trial design perspective and we have worked with many global teams that design studies. Secondary endpoints could be 3 or 7 or even more. Make sure that the study population chosen for the study is reflective of the endpoints chosen. Make sure the endpoints are not contradictory to one another. Also too many blood draws make the volunteer hesitant and increase drop outs. Too many questionnaires reduce the quality of the answers.

Yes, if the 2 ingredients are bioequivalent then the data can be used. But it would be more powerful to perform own study. But it is difficult to prove bioequivalence. Whether it is a probiotic strain or a botanical or an omega fish oil, it’s a bad idea to use someone else’s data but check local regulations. However, in the United States it is legitimate to make a claim based on another ingredient’s bioequivalence data. Though it especially makes a difference in CBD or curcumin type of pure compounds. Many botanicals have different methods of extraction and gives example of ashwagandha. For probiotic strains you need to do studies to prove efficacy more than safety. Companies need to stop looking at CTs from a regulatory standpoint only but from a business ROI standpoint.
Vedic offers small pilot size studies so that the expenditure is less on your first study.

It’s a conundrum to recruit healthy people. No one is really healthy. Everyone has something going on beneath the surface. You want to avoid having severe disease-type conditions in your inclusion criteria. Between disease and health, there is a continuous spectrum. There is no black & white. There are a lot of grey areas. So enjoy that borderline grey area. When you’re sitting at home and not seeing a doctor v/s when you reach out to the doctor and the doctor declares you a patient. Many companies are starting condition-specific claims but are still well within the border.
Vedic example: We do a lot of healthy volunteer studies. A few examples include a physically active male adult study for a muscle endurance claim, school-going children for an eye fatigue claim, office-going healthy individuals for a mental alertness caffeine study, and many others. We screen volunteers to ensure they’re not experiencing severe disease conditions and are borderline healthy in terms of BMI, fasting blood sugar, blood pressure, and other vitals.
Vedic offers small pilot-size studies so that the expenditure is less on your first study.

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