Understanding Clinical Study Reports
As part of our “back to school” series this year, we are sharing information about the various components of clinical research. We have already covered the basics of informed consent, so next up is clinical study reports.
What’s the importance of clinical study reports? Actually, their main purpose is to communicate the results of a clinical trial with the U.S. FDA and other similar regulatory agencies around the world. A clinical study report (or CSR for short) describes the endpoints or outcomes being researched, provides details on how the data were collected and analyzed, and confirms whether the study endpoints were met or outcomes were achieved. They help regulatory agencies determine if a potential new medication is safe and effective. CSRs are required documents, and study sponsors such as Lilly follow standard guidelines on what to submit. These guidelines are set by an international council, which makes it easier to write one document that will serve the needs of regulatory agencies in multiple countries.
But why would a CSR matter to a clinical trial participant? If you have participated in a clinical trial, you may have wondered what happens to all the data collected after a clinical trial has ended. Maybe you want to know more about what happens in a clinical trial, the types of people who participated in the trial, or where the trial was conducted.
Where to find a CSR
Currently, copies of the whole CSR are not publicly available, but efforts by various regulatory agencies in the US and abroad are making efforts to ensure greater transparency in the future. Until those efforts are complete, you can access results of clinical trials in a couple of ways: 1) results are shared publicly on ClinicalTrials.gov and 2) you may be able to access a short summary of the clinical study report, called a CSR synopsis. Typically, a CSR synopsis will be posted after the clinical trial has completed, once regulatory approval has occurred in both the EU and US and when the primary peer-reviewed publication is available. It should be noted that there are various formats of the CSR synopsis, from various study sponsors.
How to read a CSR Synopsis
The CSR synopsis is designed to answer very specific questions from the clinical trial it supports, for a very specific scientific audience, so the terminology might be difficult to understand. Here, we’ve listed 5 key questions to help you navigate the information in the document.
1. How do I find out where a clinical trial was conducted?
Answer: This information is commonly found in the “Study Center(s)” section. Here you can see how many research sites were used to conduct the study and, in some cases, the countries where the study was conducted.
2. How do I find out the phase of the study?
Answer: The “Phase of Development” will tell you which type of study was conducted (ie. Phase 1, Phase 2, Phase 3 or Phase 4). You may also be wondering, what the different phases mean—click here to learn more about the phases of clinical research.
3. How long was the study?
Answer: This information is typically highlighted in the section “Length of Study” and is described as the “first patient visit” or “first subject to randomized” to “last patient visit” or “last subject completed.” This does not tell you how long a person would have participated in the study individually but gives you a better idea of how long it took to conduct the study across all the patients participating. Sometimes it can take several months and other times it can take several years just to complete 1 study!
4. What was the point of the study?
Answer: This information can be found in the “Objectives” section. Typically, the researchers are trying to determine how one medicine compares to another medicine or how one medicine compares to placebo in a specific medical condition. Or you may be asking how did they test the study objectives? Check the “Study Design” section for that information.
5. Who participated in the study?
Answer: In the “Summary” section that highlights the demographics, you can find out how many men and women participated in the study and the average age among the study participants.