IBIH HL Paper 3 What You Should Know About Drug Interactions

IBIH HL Paper 3: What You Should Know About Drug InteractionsIn this first of a three-part series, I would like to touch on topics for IBIH HL Paper 3: What You Should Know and Consider in Clinical Trials. In particular, I want to focus on what might cause someone to be excluded from the study, what to do if you are, and what actions should you take if you believe you have been incorrectly excluded. After all, what is good about this study is that it is already over half done.This study, or perhaps more appropriately, this subset of the study, was designed to look at the nature of adverse events reported by volunteers who were taking a specific class of drugs (ibuprofen, acetaminophen, or both). The major purpose of this study was to see how well they can address the question of drug interactions between ibuprofen and other drugs, as well as specifically how well these drugs interact with these classes of drugs. In other words, how would a new drug effect an ibuprofen versus an aceta minophen combination?One issue that is becoming more of a concern is the kind of IBIH HL Paper 3 that fails to do any kind of analysis for demographics, such as age, gender, race, background, or other details. However, it is also important to realize that demographic data is usually collected during enrollment, or even before enrollment occurs, so there is no need to analyze demographic information. This means that we will need to look elsewhere for our demographics data.As stated above, the goal of the IBIH HL Paper 3 was to look at drug interactions between ibuprofen and other drugs. It's very easy to see how, after an initial period of careful observation, a single incident of drug interaction could become overshadowed by the overall situation. Perhaps this will happen. But it is critical to note that the outcome of the study is the number of drug interactions observed, and that is the starting point for this discussion.First, we'll look at a single interaction and determine whet her there is a significant difference between it and all other drug interactions. We'll be looking at potential differences in the effectiveness of these drugs. Of course, this is just one, of many, potentially important drug interactions. An improper selection of medication can easily make the difference between success and failure.The interesting thing about this IBIH HL Paper 3 is that there are two drug interactions, one for ibuprofen and one for acetaminophen. This is quite typical in this kind of study. There will probably be many others as well. So let's look at the ibuprofen interaction for this study.As part of the IBIH HL Paper 3, the researchers decided to look at the combination of ibuprofen and NSAIDs (non-steroidal anti-inflammatory drugs). Ibuprofen interacts with these drugs in much the same way as it does with aspirin, and the researchers wanted to see if they had a common effect. Of course, there is no such effect. Acetaminophen is much less likely to interact with ibuprofen, so we don't need to look at that. However, we do need to consider the demographics of the individuals who took these drugs, because we will need to know how they were matched to ibuprofen, and if they were in fact excluded from the study.Given that the demographic data for the participants who took these drugs was not collected at enrollment, we will have to rely on a different analysis for that subset of the IBIH HL Paper 3. This analysis should provide the information we need to determine whether the study was conducted properly.