How To Read a Clinical Trial Paper

There is a science about reading about science. Research studies are a med student’s best friend when it comes time to writing dissertations and publications for science journals. Medicine has come a long way since humans first discovered life-saving medications like penicillin. Even in ten years, drugs to help those with once thought unmanageable illnesses have come to market, helping millions. Reading those clinical trial papers explains more about why the drug is effective and why the public should care. This concept applies to both med students as well as the general public interested in educating themselves on a new drug prescribed to them.

Become well-versed in reading clinical trial papers by paying attention to the following.

Were participants recruited or those who are already patients?

The first thing is figuring out who participated in the study—knowing whether or not they are current patients or someone who volunteered plays a role in the data. For one, the number of patients in the trial will most likely increase if people registered for it. If the number of people involved in the study increases, so do the chances of having more of a variety of races, genders, and ages. It also plays a role in where a patient is at in their illness. A newly diagnosed person will have different results than someone who has been ill for years, tried multiple therapies, and experienced more complications as a result of the disease. 

The sample size of a study needs to be within a healthy range. National Center for Biotechnology Information, U.S. National Library of Medicine explains, “Too small a sample may prevent the findings from being extrapolated, whereas too large a sample may amplify the detection of differences, emphasizing statistical differences that are not clinically relevant.” Depending on the type of research you are doing, it will matter who participates. It is best to read that first before continuing to use the study or moving on to another resource.

Who funded the research?

Studies show that depending on whether a for-profit organization or a non-profit organization funds a research trial will affect the outcome of the study. In one study regarding pharmaceutical drugs, 65.5% of the industry-sponsored studies showed benefits of the newer treatment, while only 39.5% of non-profit funded studies favored the new treatment. To conclude for yourself about the trial’s results, look to see who funded the study. Drug research costs millions of dollars, so depending on who funded the research also says a lot about the research itself. Many scientific journals require who financed the research mentioned in the abstract of the article. Otherwise, authors will give out that information in the conclusion when evaluating the study as a whole.

Was it a single-blind or double-blind study?

A single-blind study is when a researcher knows which participant is receiving the drug on trial and which are receiving the placebo. A double-blinded study defined is when neither the researchers nor the participants know who is receiving a particular treatment. Very Well Mind explains that there are two benefits of a double-blind study. “First, since the participants do not know which group they are in, their beliefs about the treatment are less likely to influence the outcome. Second, since researchers are unaware of which subjects are receiving the real treatment, they are less likely to reveal accidentally subtle clues that might influence the outcome of the research.” Double-blinded studies help researchers because it prevents any biases and is more commonly the “gold” method of conducting a trial. Both have their flaws, and some tests don’t use either method. Best to find out, or else the results will seem more extreme one way or the other.

How accurate and reproducible are the outcomes?

Before jumping to conclusions after the paper concludes, do your research and see the validity evidence you read. Many clinical trials find that the outcomes are not reproducible. Now the numbers and statistics that explained the excellent result a drug had, may not look so good anymore. Too much “noise” in the data goes to the credibility of the study. Perhaps this “noise” has something to do with missing data. Always check to see if any data is missing. If so, learn how researchers concluded the study without that data. Generally, there are three ways researchers account for missing data in a study; nonresponder imputation, last-observation-carried-forward approach, and imputation. All three can conclude a clinical trial as accurately as possible. Pay special attention to when a study uses imputation. This is when researchers use other data to estimate what the missing data would have been. Some say the imputation can make the entire study questionable and not a poor resource.

Now that you know how to read a clinical trial paper, you’ll have to read many more of them to write your thesis due by the end of the semester. To get your paper done and still enjoy being a student, you need to be productive. Our personal productivity course is ideal for the busy student and professional alike. Learn more today and find out how even those with jam-packed schedules find the time to get things done.