Webinars and Video Library
Natural Clinical Trials will be posting Videos of Interest and Webinars on this web page.Latest from Video from 2010 Supply Side West:
Interview with a CEO Professor - Why Clinical Trials are a MUST!
Natural Clinical Trials Power Point Webinar
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Directors Discuss Natural Clinical Trials
Here are some videos that may be of interest.
Rima E. Laibow MD
Ralph Fucetola JD
Robert Goodman PhD
From NutraIngredients-USA at Supply Side West 2010
Good Advice: "Regulators... expect original research on the final product..."Here is a very interesting video interview about clinical trials from Dr. Jay Udani, CEO of Medicus - Click Here.
Dispatches from SupplySide West - Interview with Dr Jay Udani - CEO, Medicus Research By Stephen Daniells, 27-Oct-2010, duration 05:12
"Increasing regulatory pressure around the globe is focusing attention on supporting the efficacy of ingredients and products. Dr Jay Udani, CEO of Medicus Research, gave us his 5 secrets for clinical trials success.
"At the ... SupplySide West show in Las Vegas, Dr Udani, also an associate clinical professor at UCLA, explained that companies can no longer piggy-back on the science of others, and must undertake clinical trials now.
"In my opinion, over the next two to three years a company that still wants to be on the market and on the shelves needs to start investing in clinical trials today," said Dr Udani.
"Dr Udani explained that success is defined as successfully supporting the claims in the market place, and he then explains how to achieve this success with clinical trials. "
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Notes from the video on the 5 Secrets for Clinical Trial Success:
1. Why: because of the regulatory requirement to substantiate your claims to support your marketing.
2. Who: the population of who is being tested; the wrong population can get the product labeled as a "drug."
3. What: the serving and dose level: dose escalation study; or test the highest safe, available serving.
4. Where: phenotype expression - overseas subject similar to US population with similar nutrient needs.
5. How: do you select endpoints related to mechanism of action that are not also disease endpoints?
Important factors include primary and secondary endpoints and the development path. Use "adaptive design methodology" designed to run small pilot studies, perform interim analysis, then run "true power calculations" to see how many subjects are required to see true statistical distinctions between groups. Companies may find that they can account for their clinical trials as part of their R&D budget, with the usual tax credits for such research and development.
The final word from Dr. Udani: "you can't afford not to do it if you intend to be in business in two to three years..."
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