Pathway of a Clinical Trial

Friday, July 31, 2015

At this very moment, scientists are suited up in lab coats and goggles, working hard to improve Synergy WorldWide’s product offering and product efficacy in The Hughes Center for Research and Innovation.

Efficacy is a word that is often used when discussing product formulations, and its meaning describes exactly what Synergy WorldWide’s focus is: creating products that are scientifically proven to work. An efficacious product is one that does precisely what it was intended to do, and Synergy products are intended to help you live life fully with a complete and trusted health system.

“It is one thing to say that a product works, but it’s another to say there is proof that a product works,” said Dr. Joseph Lamb, The Hughes Center’s medical director. “Because of this lab, you will be able to sit down with a business partner and tell them about our unique ingredient combinations, about how these products weren’t just created by three guys in a meeting room with a few medical books and limited funds. Our goal is to deliver valuable products and product information to as many groups as possible.”

Without testing products on human subjects, it’s impossible to know how effective the products are, which is why the Hughes Center’s clinical labs are imperative to the future development of Synergy WorldWide and its product line. The process leading up to performing a clinical trial is extensive and requires months of preparation. Take a walk through the clinical process that scientists execute as they work to prove that Synergy products are among the best in the nutritional supplement industry.

The Idea

All clinical trials begin with a lightbulb moment. When the clinical teams develop a substantial idea based on the most important nutritional and health needs of the modern world, they begin combining safe ingredients and performing self-studies. When the research team discovers a formulation that they feel confident about presenting, they meet with the independent review board composed of company executives and personnel from various company departments about whether this product makes sense from a business perspective.

The Protocol

Every clinical trial needs a clear set of directions. Questions including “Who do we recruit and test? How many subjects do we need? How old are the subjects? Are they generally healthy enough to participate? How do we instruct subjects to take the product? What information do we want to collect?” The protocol goes through several drafts and is questioned in detail by several company departments. Dozens of additional questions—“Is the study unique? Is it ethical? Is this the best subject demographic?”—are asked as these departments consider how influential the trial will be to Team Members who are looking to market the product with clinical proof. After these questions are finalized and organized into a protocol, the protocol is sent to an outside review board (IRB) for input and approval.

The Subjects

Based on the protocol’s final instructions, the clinical team begins searching for the correct group of subjects. Often, subjects are recruited within the walls of the Synergy WorldWide and Nature’s Sunshine office buildings. When a more specific group of subjects is required, the clinical team will seek the help of the marketing team to publicize the study and recruit the target demographic. When the group is selected, each participant comes into the lab for an initial meeting where the trial objective and product usage is explained and screening lab work is conducted to ensure the subject is healthy enough to participate. The subject may come back multiple times throughout the trial period to report results or once at the end of the trial period, depending on the study.

The Data

Thousands of data points are compiled over the period of a clinical trial including physical samples. A study of 20 subjects can produce more than 560 individual samples. These samples are then kept in two freezers that are large enough to store more than 45,000 samples per freezer. The samples are kept at -80° Celsius to maintain each sample’s integrity. The clinical team will use additional testing groups within Synergy and NSP’s scientific teams to evaluate the collected specimens using a number of tests. For example, a bioavailability study shows the degree and rate at which a potential product ingredient is absorbed into the human body. Measuring nitric oxide levels in the blood indicates whether or not a subject is getting proper nutrition. An Endopat is a non-invasive test to assess cardiovascular health and risk factors. These are examples of literally hundreds of test that may be performed to assess the safety and efficacy of a given product.

The Conclusion

When every specimen is analyzed, study results are compiled and evaluated for statistical significance. The clinical team must measure the new product’s impact and determine whether or not it is ready for the market. Every detail carried out in a clinical trial is in anticipation of these results.

The findings that emerge from The Hughes Center’s clinical labs have the potential to cause rapid growth in Synergy’s markets, and thanks to the knowledge of brilliant scientists, the information they can uncover is limitless. Only through the innovative research conducted at the Hughes Center can the true potential resting in Synergy’s proprietary formulations be unlocked.

Click here to tour the Hughes Center for Research and Innovation
Click here for more articles from this summer's eMagazine

Synergy WorldWide

Some say he’s half man half fish, others say he’s more of a seventy/thirty split. Either way he’s a fishy bastard.

0 comments: