Douglas Kalman, PhD11.01.09
Many believe that if you do the right thing according to ethical and moral standards, then good things will follow. Many more also maintain community standards as an important priority in life. These central themes can be applied to the business world. Currently, there is ongoing congressional and regulatory concern regarding adulteration of sports nutrition products within the larger nutrition industry. More to the point, many within Congress strongly intimate, as do leaders of agencies such as the World Anti-Doping Agency (WADA), that the nutrition industry is unregulated and the sports nutrition sector is to blame for steroids in dietary supplements, among other quality issues. You may be asking, “How does this relate to research?
In the food industry (and let’s face it, the supplement industry essentially falls under “food” from a regulatory perspective), as well as the pharmaceutical industry, FDA sets the tone in terms of laws and guidance documents regarding manufacturing, labeling, storage and so forth. Meanwhile, the Federal Trade Commission sets the tone in terms of advertising, marketing practices and scope allowed (guidance and laws). Thus, the tone for “staying within bounds” has been set by legislation. In terms of community standards, depending on your purview, these can be set both by the industry and regulatory agencies. The difference might just be in which community you live. Ideally, the safest and most productive long-term means for a nutrition company to thrive is to live within a community that maintains high standards and translates these into goodwill and continuing education for all interested parties.
When examining how Congress, Major League Baseball, WADA, the United States Olympic Committee (USOC) and others have publicly discussed dietary supplements, the tone toward the industry appears to be one more of distrust and snake oil salesmen than a responsible industry trying to work with regulatory bodies to further confidence. Take, for example, the September 29, 2009 congressional hearing regarding steroids in sports nutrition supplements. Examining the general tone of the supplement industry’s response to these concerns has been interesting. One central voice or one themed message in response to a challenge is often the most successful means to overcoming that barrier. Does the industry need to reconsider how it responds to concerns that have been in the media for the past decade or so? If so, how can we ensure regulatory confidence, consumer confidence and working partnerships, other than by attending congressional hearings?
Once again, television, newspapers, “webzines” and blogs have noted that tainted or adulterated sports nutrition products are an issue. Concerns have included trust in label claims (GMP, honesty/integrity issues), adulteration (purposeful and non) and so forth. The response from Dr. Daniel Fabricant and Steve Mister has been spot on—that federal agencies already have the power to regulate, inspect and curtail illegal activities (such as the purposeful filling of a steroid into a sports nutrition product) and consequently, need resources to enforce existing laws. Both sides agree on one point: True clinical trials on finished products (as well as raw materials) for safety and efficacy (sometimes one or both endpoints) would allow for better clarity, more supported marketing and stronger confidence in the products and the industry overall.
Industry leaders can set the tone by being active—reactive or proactive. Being that this is a commerce-driven society, there is often temptation to increase sales by taking shortcuts (e.g., breaking laws, using inferior ingredients, shorting weight/volume on product, etc.). There is a barrier of trust to overcome, but the tone can be reset. It is all in the response to these latest regulatory concerns, and whether the industry can start a truly effective self-policing group to help weed out or report the “rebels” and “rogues” who help maintain the false notion that the products sold by industry are a waste of money. Having proof for your claims can set the tone. The best proof is from properly conducted and completed clinical trials.
One of the key factors in the decision to conduct clinical research is the knowledge that it can provide regarding your product. In addition, objective research allows for a more honest evaluation of a product—and this is why regulatory agencies want research to be conducted for scientific reasons along with market support. The difference is that objective research can be verified and duplicated by another lab—yet the industry for the longest time has appeared to rely on testimonials as substantiation.
Therefore it is of utmost importance to ask the right questions and utilize the right protocol when designing a study. Having the research team select the right measures (and endpoints) can have a dramatic effect on the trial’s success or failure. Setting the study up for success should be the priority.
Terms to be familiar with include:
Objectives: Objectives are typically categorized into primary, secondary and sometimes tertiary. The idea is to define the objectives of the clinical trial so that order is evident and a clear relationship can be noted. Most studies also further classify objectives in terms of safety and efficacy (effectiveness). Each has its own hierarchy unless the study is a pure safety trial. Obviously, the primary objective of any study is most important, at least within the confines of the study design. If a study does not meet the primary objective, then many will consider it a failure, or not as strong. However this is not always the case.
Measure: A measure is numeric or mathematical in nature. One example is a scale. The scale can measure your weight (a number).
Endpoint: An endpoint is the clinically relevant aspect being measured. If testing blood pressure, the change in blood pressure over time is the endpoint.
Accuracy: This defines how well the measure reflects the experience being observed.
Precision: Precision is reflective of how reproducible the measure is. For example, typically in lab science, tests are run in triplicate in order to see how close or exact each measurement is. For some tests, once two measures or numbers agree, a third test is not needed. If one gets three divergent numbers, the accuracy needs to be rechecked.
The above introduction to clinical research terms and relevance is meant to be a guide on a few things to consider when discussing research or proposed studies with CROs or university-based research groups. Ask your research group or consultant to review the importance of understanding these terms before a study design is finalized.
Getting the objectives with the appropriate measures and endpoint—accounting for how one would confirm the accuracy and precision of the data accumulated in a clinical trial designed to support a product’s use—is paramount to designing clinical trials. One can never guarantee results of a clinical trial; so make sure there is transparency in the study design. In addition, choosing the right design will ultimately allow for the greatest use of science to support a finished product. I believe that directly sponsoring research on ingredients and finished products will help the public and regulatory agencies gain confidence in the industry, ultimately serving to support natural products designed to enhance quality of life.
Who Sets The Tone?
In the food industry (and let’s face it, the supplement industry essentially falls under “food” from a regulatory perspective), as well as the pharmaceutical industry, FDA sets the tone in terms of laws and guidance documents regarding manufacturing, labeling, storage and so forth. Meanwhile, the Federal Trade Commission sets the tone in terms of advertising, marketing practices and scope allowed (guidance and laws). Thus, the tone for “staying within bounds” has been set by legislation. In terms of community standards, depending on your purview, these can be set both by the industry and regulatory agencies. The difference might just be in which community you live. Ideally, the safest and most productive long-term means for a nutrition company to thrive is to live within a community that maintains high standards and translates these into goodwill and continuing education for all interested parties.
When examining how Congress, Major League Baseball, WADA, the United States Olympic Committee (USOC) and others have publicly discussed dietary supplements, the tone toward the industry appears to be one more of distrust and snake oil salesmen than a responsible industry trying to work with regulatory bodies to further confidence. Take, for example, the September 29, 2009 congressional hearing regarding steroids in sports nutrition supplements. Examining the general tone of the supplement industry’s response to these concerns has been interesting. One central voice or one themed message in response to a challenge is often the most successful means to overcoming that barrier. Does the industry need to reconsider how it responds to concerns that have been in the media for the past decade or so? If so, how can we ensure regulatory confidence, consumer confidence and working partnerships, other than by attending congressional hearings?
Once again, television, newspapers, “webzines” and blogs have noted that tainted or adulterated sports nutrition products are an issue. Concerns have included trust in label claims (GMP, honesty/integrity issues), adulteration (purposeful and non) and so forth. The response from Dr. Daniel Fabricant and Steve Mister has been spot on—that federal agencies already have the power to regulate, inspect and curtail illegal activities (such as the purposeful filling of a steroid into a sports nutrition product) and consequently, need resources to enforce existing laws. Both sides agree on one point: True clinical trials on finished products (as well as raw materials) for safety and efficacy (sometimes one or both endpoints) would allow for better clarity, more supported marketing and stronger confidence in the products and the industry overall.
Industry leaders can set the tone by being active—reactive or proactive. Being that this is a commerce-driven society, there is often temptation to increase sales by taking shortcuts (e.g., breaking laws, using inferior ingredients, shorting weight/volume on product, etc.). There is a barrier of trust to overcome, but the tone can be reset. It is all in the response to these latest regulatory concerns, and whether the industry can start a truly effective self-policing group to help weed out or report the “rebels” and “rogues” who help maintain the false notion that the products sold by industry are a waste of money. Having proof for your claims can set the tone. The best proof is from properly conducted and completed clinical trials.
An Overview of Clinical Research
One of the key factors in the decision to conduct clinical research is the knowledge that it can provide regarding your product. In addition, objective research allows for a more honest evaluation of a product—and this is why regulatory agencies want research to be conducted for scientific reasons along with market support. The difference is that objective research can be verified and duplicated by another lab—yet the industry for the longest time has appeared to rely on testimonials as substantiation.
Therefore it is of utmost importance to ask the right questions and utilize the right protocol when designing a study. Having the research team select the right measures (and endpoints) can have a dramatic effect on the trial’s success or failure. Setting the study up for success should be the priority.
Terms to be familiar with include:
Objectives: Objectives are typically categorized into primary, secondary and sometimes tertiary. The idea is to define the objectives of the clinical trial so that order is evident and a clear relationship can be noted. Most studies also further classify objectives in terms of safety and efficacy (effectiveness). Each has its own hierarchy unless the study is a pure safety trial. Obviously, the primary objective of any study is most important, at least within the confines of the study design. If a study does not meet the primary objective, then many will consider it a failure, or not as strong. However this is not always the case.
Measure: A measure is numeric or mathematical in nature. One example is a scale. The scale can measure your weight (a number).
Endpoint: An endpoint is the clinically relevant aspect being measured. If testing blood pressure, the change in blood pressure over time is the endpoint.
Accuracy: This defines how well the measure reflects the experience being observed.
Precision: Precision is reflective of how reproducible the measure is. For example, typically in lab science, tests are run in triplicate in order to see how close or exact each measurement is. For some tests, once two measures or numbers agree, a third test is not needed. If one gets three divergent numbers, the accuracy needs to be rechecked.
The above introduction to clinical research terms and relevance is meant to be a guide on a few things to consider when discussing research or proposed studies with CROs or university-based research groups. Ask your research group or consultant to review the importance of understanding these terms before a study design is finalized.
Getting the objectives with the appropriate measures and endpoint—accounting for how one would confirm the accuracy and precision of the data accumulated in a clinical trial designed to support a product’s use—is paramount to designing clinical trials. One can never guarantee results of a clinical trial; so make sure there is transparency in the study design. In addition, choosing the right design will ultimately allow for the greatest use of science to support a finished product. I believe that directly sponsoring research on ingredients and finished products will help the public and regulatory agencies gain confidence in the industry, ultimately serving to support natural products designed to enhance quality of life.
