Whether it is patients in a clinical study or mouse models in preclinical research, it’s important to understand information about the participants. What are the ages like? What common health conditions do they have? A common way to present this information is via descriptive statistics, and while these statistics can be presented in various forms, the most common way is using tables. In the context of a Clinical Study Report (CSR), the set of tables and figures is called the “TLF” (which stands for “Tables, Figures, and Listings.”)
So, what goes in the TLF specifically? Regardless of the trial, there are often a number of common tables you will likely see:
The first table that is commonly included in a CSR is a table summarizing the demographics of the study participants. This table typically includes variables such as age, gender, ethnicity, and other relevant demographic information. The purpose of this table is to provide a clear picture of the population being studied and to identify any potential biases or confounding factors that may impact the results.
The second table that is commonly included in a CSR is a table summarizing the baseline characteristics of the study participants. This table typically includes variables such as disease severity, comorbidities, and other relevant clinical characteristics. The purpose of this table is to provide a clear picture of the baseline characteristics of the study population, which can be used to assess the effectiveness of the intervention being studied.
Descriptive Statistics by Treatment Group
Another common table in the CSR summarizes the descriptive statistics by treatment group. This table typically includes variables such as mean, standard deviation, median, and range for each treatment group. The purpose of this table is to provide a clear picture of the distribution of data within each treatment group and to identify any significant differences between the groups. This type of table can break down characteristics or demographics by treatment group or focus on measurements such as the primary or secondary outcomes.
Finally, another very common table in the CSR describes the adverse events experienced by study participants (these are essentially side effects with challenging outcomes, such as nausea or worse). This table typically includes variables such as the number of participants reporting the event as well as the type.
The above tables are pretty standard in any CSR, so if you are looking for early guidance as you write your first one, or you’re an old-hand looking for a pointer to send to colleagues, we hope this brief description of some of the common tables helps! And if you need help generating these tables, automatically, ReadoutAI is here.