Major medical societies like the American Society of Hematology (ASH) generate cutting-edge clinical research. Annually, ASH plenary and late breaking sessions present the most important and potentially practice-changing clinical studies. Over the past 2 decades, significant efforts have been made to highlight inequities in medical oncology research, yet, disparities in cancer treatment remain. These disparities are a major contributor to diminished outcomes in cancer mortality, and may be related to the underrepresentation of minoritized populations in clinical research.
The DRIVE ranking score was designed to measure the relative representation of participants in clinical trials (Birhiray and Birhiray, 2022). Target population representation in clinical trials is vital for transportability, generalization, and external validation of the data generated. We have defined a minimum DRIVE score of 3 for clinical excellence and relevance based on racial representation.
The aim of this study is to retrospectively evaluate the ethnic diversity in cancer research by determining the DRIVE score in past ASH plenary and late breaking sessions.
Between 2010-2023, a total of 169 abstracts were presented at ASH annual meetings. Through a systematic review, 72 ASH plenary and late-breaking abstracts containing human subject participants were identified. Each study was reviewed for demographic data and the reporting of the presented racial composition. Subsequently, a DRIVE score was calculated for each study, a score between 0 and 5 or assigned “N/A” if no demographic data was provided.
The acquisition of the plenary and late-breaking session abstracts used in this analysis included the identification of Annual Meeting issues from 2010 to 2023, or the subsequent indicated volumes of the ASH publication Blood.
Demographic information was assessed as available at the time of ASH publication. Therefore, any studies that were ongoing at the time of publication may have additional demographic data not reflected in this analysis. The data was evaluated this way to ensure the trials were examined based on the values on which they were selected to be plenary or late-breaking sessions.
A total of 72 abstracts meeting the defined criteria were identified for analysis, and an overwhelming lack of demographic data was found within these clinical trials. Of the 72 abstracts analyzed, only 6 studies provided sufficient data for a DRIVE score to be calculated. These 6 studies received the following DRIVE scores: 0, 3, 0, 3, 5, and 0 (Castaigne, et. al, 2011; Wood, et. al, 2014; Stone, et. al, 2015; Hochhaus, et. al. 2020; Locke, et. al, 2021; Aldoss, et. al, 2023). Throughout the 14 years of studies, only 3 studies reached the threshold of “good” representation, as stated previously.
One of the primary reasons these studies received a high score was the inclusion of participant racial/ethnicity data. A DRIVE score cannot be calculated unless demographic data is provided. The studies receiving a score of 3 or above included a table with all demographic data and baseline characteristics.
Representation of target populations in clinical trials is an essential step in addressing disparities in clinical outcomes. Although it may take time to collect racial and ethnic clinical trial data, it is crucial for improving outcomes in minority groups and is vital for true transportability and generalizability. These concepts are key to the external validity of clinical research, ensuring that data accurately represents the population being treated. Without this, the data is biased and unsafe.
ASH plenary abstracts are incredibly prestigious and sought after due to their clinical utility providing a significant opportunity to highlight research that is generalizable and useful for clinicians serving diverse patient populations. Implementing a strategy similar to the NEJM's “Diversity in Research Studies” statement could be a vital step in this direction. As the largest professional society for hematological malignancies, ASH has a responsibility to maintain transparency with patients, clinicians, and scientists, and to promote data that is both reliable and valid.
Ranger:Iqvia: Ended employment in the past 24 months. Birhiray:Array Biopharma Inc., Lilly Oncology, Janssen Scientific Affairs LLC, Epizyme, TG Therapeutics, Regeneron, Janssen, AbbVie, Takeda, Sanofi, and Ipsen: Membership on an entity's Board of Directors or advisory committees; Janssen Biotech, Inc., Amgen Inc., Puma Biotechnology, Inc., Lilly Usa, LLC, Incyte Corporation, Pharmacyclics LLC, an AbbVie Company, Genzyme Corporation, Dova/Sobi Pharmaceuticals, Exelixis Inc., E.R. Squibb & Sons, LLC, AstraZeneca Pharmaceuticals LP,: Speakers Bureau.
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