SNJ ASSOCIATES RESEARCH NEWS AND INFORMATION
WEEKLY DIGEST JANUARY 11, 2016
This week’s digest takes a look at outcome switching in clinical trial research regarding the drug Paxil, a clinical trial registry called ClinicalTrials.gov along with cholesterol dietary advice in the United States
Research Studies and Outcome Switching...What the Heck
Vox Science and Health directed our attention recently to a serious and important issue in research studies, known as ‘outcome switching’. A cornerstone of research is using a systemic process to ensure research is a reliable and valid representation of the information presented (See our discussion on What is Research?).
One such component of the process requires, particularly in clinical trials that the investigators declare their outcomes (or events they are looking for and most interested in observing and analyzing from all of their results) before or A PRIORI. This process prevents simply reporting on outcomes that turn out better compared to the outcomes the research question and hypothesis are designed to investigate. When this occurs it is called ‘outcome switching’, which has a huge impact in how we accumulate our overall research knowledge.
Vox Science and Health demonstrated this problem by outlining how the research process and publication of information regarding Paxill, which was prescribed to over 2 million children and adolescents. Unfortunately this is not an isolated incident and we all have a responsibility in research to advocate for better and more transparent processes to ensure the research information we all use is robust and in the best interest of the public.
Clinical Trial Registry
At SNJ Associates, we pass along resources in the area of research that are helpful in many ways to our clients and users. Today we want to share the ClinicalTrails.gov website. This is a fantastic resource to use when looking for clinical trials involving human participants from around the world. The database is user-friendly and very easy to search by location, health topic, trial status and more. In fact, we use the database so frequently here at SNJ Associates we’ve added it our Research Helper page.
Related to our discussion concerning the issue of ‘outcome switching’ in the article above, we wanted to highlight how registries such as the ClinicalTraials.gov are proving useful in helping to create research that is more robust, accountable and trustworthy.
In many instances now, leading academic journals require investigators, who would like to later submit their research results for publication to register their studies BEFORE any research processes begin. The information registries include are the investigators primary and secondary outcomes of interest along with other details about how and where the study will be conducted.
Importantly, the registration takes place before the trial begins thus, outcome switching during the analysis phase is reduced and/or eliminated. For more details review the outcome switching article above and then come back to the clinical trial database and see how it all works.
Policies Regarding Low-Fat, Low-Cholesterol Dietary Advice
As far back as the 1900’s, Americans were told to reduce their overall consumption of cholesterol through the research of a man named Ancel Keys, who was a physiologist. Years later in 1961, the American Heart Association had adopted the guidelines to reduce cholesterol and the continued for years. Yesterday, here at SNJ Associates we began a discussion about influence and bias in research and today an excellent example has hit our media headlines. A combination of less than robust science, industry sponsored messaging and news media promotion helped perpetuate the myth of increased cholesterol and poor health outcomes for decades. To read more check out Nina Teicholz work titled: The Big Fat Surprise: Why butter, meat and cheese belong in a healthy diet. And as a critical consumer of health research here at SNJ Associates remember that nutrition education is nearly non-existent in medical school….