January 27, 2010

My last BlogTalkRadio Show was devoted to a discussion concerning "What is Nutrition Research?".  The subject for that Show was based on the fact that many companies/individuals loosely use the word "Research" when referring to their products or programs. Since that Show, I have gotten several inquiries asking additional questions concerning the understanding and evaluation of nutrition research.

I often am puzzled and confused by references to nutrition research by individuals promoting (selling) nutrition products or programs. The challenge comes from my years of doing research at universities. Requirements and criteria for university-based research are very specific and demanding. Additionally, the only accepted research in a true science environment are articles published in referred scientific journals. Any other references to "research" are considered by academia just opinions.

 I recently had a Canadian trained physician friend state "People from the US seem to have a need to hear "research" about nutrition products. Nowhere else in the world is this the case."  I agreed because it seems that sales materials for US companies' nutrition products somewhere refers to "research". However, much of this "research" in these documents is not referenced or does not exist.

For example, there was a nutrition company advertising that it was a "research" based company. Additionally, this company spent a lot of effort discussing its extensive sponsored university research. All of this sounded good to me. Therefore, I decided to follow-up by requesting copies of their university research. Additionally, I spoke with that company's Chief Science Officer to review their research program. Well, I was promised copies of the research reports immediately. However, nothing came after 6 months. I also found that my telephone calls to that company began not to be returned.

Next, I decided to verify this company's claims of university sponsored research myself. After several telephone calls to this company's "university research partners", I was very disappointed.  I confirmed the company was doing "research" with at least one university. This "research" involved the company sending product samples to the Michigan State University Soils Laboratory for routine chemical analysis. It seems to me it is a real stretch to claim this as company sponsored university research. Unfortunately, the average consumer would never know the difference between real research and a scam.

For your benefit, let's cover the various types of research categories. I also will let you know that the only research to be considered does not have to be published in referred scientific journals. There is good company sponsored research that is never published in a scientific journal but is worthwhile. Moreover, there are companies that make available summaries and reviews of published research articles. This type of information also is valuable.

It might seem that every company should do university research. However, the cost of university research can be prohibitive. Additionally, the time from the start of a university research project until its completion can be years. Moreover, companies are not assured of a positive outcome. Thus, university research can be expensive and time consuming as well as it can be a "crap shoot". However, most companies have enough experience with their products that results from a university trial will have better than a 50/50 chance of success.

The minimum cost of a very simple university study is about $50,000. However, most studies run several $100,000 to $1,000,000 each. Most of the time it is not the actual cost of the study that drives up the price but rather the university overhead that is added. University overhead involves the administrative costs to the university. These administrative costs can be as low as 50% to as high as 86% of the total study cost. In other words, if the true cost of a university trial is $100,000, the company will have to pay the university between $150,000 and $186,000. The difference in the percentage overhead is related to the "name" of the university not the quality of the research. A less recognized university charges less overhead than a "big" name school. However, there is not much difference in quality of the research.

Time required for the completion of a university research study also is a factor to consider. The normal procedure would involve the company meeting with the university researchers to establish goals for the trial. Next, the university researcher develops a research protocol. This document is a very detailed description of the project, procedures, requirements as well as staff needs and supervision required. Sometimes the research protocol can take 3 to 6 month to finish.

After the research protocol is finish, it next goes to a university Internal Review Board (IRB). This board is composed of other university researchers as well as administrators. There are two main purposes for the IRB. First, it evaluates the statistical design of the trial as well as its scientific validity. The second purpose of the IRB is to evaluate the possible liabilities the university may have if the trial is started. These IRB reviews can be very political within a university. IRB approval can take 6 months to 1 year.

After IRB approval, it may take over 6 months to organize, allocate and begin the actual trial. Most nutrition research trials can last up to 1 year. After the trial is finished, it may take up to 1 year to finish the statistical analysis, summarize and write a finial report. Most university researchers are notorious for being slow at writing the final report. Therefore, many companies agree to pay one-half the cost of the trial when the IRB is approved. The final payment is made when the final report is received. This type of payment agreement tends to speedup the final report. However, it is easy to see that a university research trial may take 2-3 years before the planning, implementation and results are completed.

There usually is a decision by the sponsoring company on how the results should be published - refereed scientific journal or a less prestigious company news release. Universities have agreements that the results from the study can be published in a scientific journal. However, if the results are not positive to the sponsoring company, most universities will not publish any negative results because the company funded the trial.

If the results from the trial are positive, the company has to make a decision if the results are to be published in a scientific referred journal or as a company publication. The scientific journal is by far the most pristine way to publish the results.  However, it is the longest route to publish. Scientific journals usually are sponsored by science societies. For example, the American Journal of Nutrition is sponsored by the American Nutrition Society.

The science journals are administered like any other publication with an editor.  However, the editor of a scientific journal usually is a recognized researcher as well as author. A science manuscript is submitted to the journal for review. There are 2-3 reviewers (referees). These reviewers are anonymous - only known to the Editor. The purpose of the journal reviewers is to evaluate: 1.) the scientific worthiness of the manuscript for publication and 2.) the scientific significance of the findings. 

The manuscript can be: 1.) accepted as-is, 2.) accepted with changes, 3.) more information requested or 4.) rejected. It is not unusual for a scientific manuscript to go back and forth with peer reviewers for over a year. During the journal review process, findings cannot be released or published in any other form. If the results are published elsewhere, the manuscript is rejected.

Thus, it can be 12 to 18 months after the final university report is available before a referred scientific journal article might be published. Most companies cannot wait that long to have the information available for marketing and sales. After all, university research is used to support company sales.

A company can have a very well designed and implemented university study. However, they cannot wait to have the results published in a referred scientific journal.  However, there is an alternative. The researchers can publish a one-paragraph summary of their findings as an abstract in the journal proceeds section. These abstracts are not reviewed. However, abstracts do allow the results to be in the public domain. I often would publish preliminary results as an abstract while I was preparing a full journal manuscript. This allowed for some of the results to be available while the manuscript would contain all of the results. However, as you can see, the scientific/university route can be time consuming.

One of the reasons I got out of pure research was because it took so long to get findings out that would help people's lives. I usually figured that it took 7 years to go from research planning and funding to a published journal paper. A lot of that time was involved with university (institution) politics and journal politics. I felt that it was a waste to have findings that would help someone's life but not be able to publish it. It placed a lot of stress on me because I was doing research to help people - not to be published in scientific journals.

 

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