Understanding the Importance of Clinical Trials

As consumers, we take heed to our doctor's orders and take our prescribed medications faithfully. We fail to take a deeper look into the drugs we're consuming, as we assume they are safe. As demonstrated clearly over the past couple of years, the dangers associated with certain prescription drugs, due to the manipulation of clinical trials, is prevalent and clearly a risk to all consumers.

In March and May of 2007, the Food and Drug Administration (FDA) issued a warning to inform the public and medical professionals of the danger associated with the drug, Avandia. Avandia is a diabetes medication intended to help those with type-2 diabetes control their glucose levels. According to reports from the FDA, the manufacturer of the drug, GlaxoSmithKline, knew about the heart risks and serious side effects, such as stroke, congestive heart failure, and pulmonary embolism, but did not warn consumers. A study in 2007 showed the relative risk of a heart attack while taking Avandia was increased by 43 percent.

A randomized clinical trial is the most utilized method when attempting to confirm the safety of a new drug. The analysis of the results and the source of the funding are all critical areas that have been scrutinized by the FDA in great depth, following the case of Avandia. A major concern with the Avandia trials was that in the results reported to the FDA, only those who finished the study were included. Those who dropped out of the study due to negative side effects were not included. According to an article in The New York Times, the factors that should be analyzed in a trial include, but are not limited to, primary or tertiary care setting, the method used to select the participants, methods employed to detect health outcomes, study duration, assessment of adverse events, and sample size. If only a certain group of people are included in the study, such as one gender, age, or race, the results will be misrepresentative, and if those results are in favor of the manufacturer, they will be the primary tool used to become approved. Lastly, if the person reviewing the results is not educated to do so, the results may be misinterpreted.

In addition to the actual interpretation of results, the source of funding that allows a clinical trial to exist proves to be a major deciding factor in the interpretation. When a large pharmaceutical company has developed a new drug that can be potentially profitable, they tend to view the trial's results in the most favorable light. Positive results are proven to be the most favorable way for a new drug to be approved by the FDA. If the trial is funded by the manufacturer, researchers may feel that reporting positive results could be linked to more funding in the future. In an analysis by Cary P. Gross, an associate professor of medicine at Yale, industry sponsored research was positive 87 percent of the time compared to only 65 percent of the time when the research was funded by sources outside private industry. If a research trial is privately funded and the results are unfavorable, there is no law mandating the results be published. A former employee of the FDA recently published research demonstrating that "when studies of antidepressants were negative, they were reported as negative only eight percent of the time, but when studies were positive they were reported as positive ninety seven percent of the time."

As the health of America has been compromised, the FDA has implemented new strategies to further assure individuals that the drugs being released are safe. The FDA has established a Clinical Trials Transformation Initiative, which is a partnership between the private and public sectors to act together to improve the quality and efficiency of clinical trials. In 2009 the American Recovery and Reinvestment Act provided $1.1 billion dollars to support effectiveness research of randomized clinical trials. The initiative has combined the efforts of those in academia, government, private industry, and patient advocates, to address key areas including study design principals, data quality, study start up, and adverse event reporting. With all of America working together, the future of our health seems to be promising.