The following is a summary of “Representation and reporting of diverse groups in randomized controlled trials of pharmacological agents in inflammatory bowel disease: a systematic review,” published in the December 2023 issue of Gastroenterology by Pathiyil et al.
The incidence of inflammatory bowel disease (IBD) is quickly growing in newly industrialized nations in South America, Asia, and Africa. It is increasingly recognized as a worldwide disease. As a result, clinical trials in inflammatory bowel disease (IBD) should appropriately represent varied groups in terms of gender, age, place of residence, race, and ethnicity. This was necessary to guarantee that the results of these trials may be applied globally and generalized.
For a comprehensive review, researchers searched PubMed and Embase for randomized controlled trials (RCTs) published in English between January 1, 1995, and January 13, 2023. These RCTs evaluated the effectiveness of any pharmaceutical intervention in patients diagnosed with inflammatory bowel disease (IBD). 617 entries providing data from 627 randomized controlled trials (RCTs) and 108,986 people were included in the search, which gave a total of 7543 records. The findings indicate that these randomized controlled trials (RCTs) must adequately represent various populations.
The particular conclusion was seen to be valid for a variety of groups, such as populations that are racially and ethnically diverse, older populations (being over 65 years old) and younger (being under 18 years old), individuals who identify as belonging to a gender that does not fall into the binary, and individuals from South America and Africa. Additionally, many locations lacked sufficient sources of financing for clinical studies. Pharmaceutical firms and clinical trial organizations must make it a priority to guarantee that under-represented populations are adequately represented in any future inflammatory bowel disease (IBD) studies.
Source: sciencedirect.com/science/article/abs/pii/S2468125323001930