The DRIVE score ranking system was created as a readily understandable informational tool to measure the relative representation of participants in clinical trials (Birhiray and Birhiray, 2022). This ranking system highlights the current underrepresentation of minoritized populations in clinical research. An issue that is further exacerbated by the use of this data for regulatory approval of medications and devices while lacking representation of the populations they are intended to treat.
DRIVE scoring uses a 6-point system to evaluate how accurately a clinical research study represents the epidemiology of the disease.
A score of 3, which is the minimum score for clinical trial excellence, signals between 41% and 60% of the total representation of all minority groups in relation to the disease's epidemiology, with at least 2 minority groups achieving 60% representation relative to the disease's epidemiology. For the full ranking breakdown, please review Birhiray and Birhiray, 2022.
DRIVE scores were initially determined using a cumbersome manual calculation, necessitating a more efficient solution. Thus we developed an automated system to achieve easier calculation via a free web-based application.
We established disease epidemiology through the NIH's Cancer Statistics Explorer Network, SEER*Explorer. Access to non-normalized data in SEERStat allowed for more scalable calculations. The SEERStat steps to find this data were as follows: creation of a new frequency session and selection of the database “Incidence - SEER Research Data, 8 Registries, Nov 2023 Sub (1975-2021)”. Under “Statistic” the “Percentages” was changed to “column”. In the “Selection” menu, Malignant Behavior was unselected. The “Site recode ICD-O-3/WHO 2008” under “Site and Morphology” variable was chosen, followed by the desired cancer type. All values under the “Race and origin recode” of “Race and Age (case data only)” were included. Finally, the variables were placed in the “Table” tab and data was generated. Calculations were verified in Excel, then translated to R for improved graphs and infographics, and finally to Python for greater versatility and ease of use. This completed system is called the “DRIVE Calculator.”
The DRIVE calculator was internally validated through repeated interrogation and further evaluated with an external survey of attendees in July 2024 at the D.R.I.V.E. Lymphoma and Myeloma Investigators Summit at the Pan-Pacific Lymphoma Conference using both an online and written form. The survey was based on the principles of data generalizability and transportability. External validation revealed that the calculator was accurate and easy to understand and use. Concerns raised included globalization, expansion of cancer types and subtypes, and further geographical data breakdown. Plans for national expansion involve providing greater availability of geographical breakdowns in the U.S. by region and state. Current cancer types listed on the calculator are limited by data availability from SEER; however, we are exploring the use of additional data sources. We are also aiming to enhance support systems for clinical trial participants with this tool. The DRIVE calculator is available for use at https://drive-score-calculator.vercel.app/
We have created a tool for evaluating clinical trials for representativeness using the DRIVE Score with validated data from the SEER database. DRIVE Score Calculator, is a web-based tool demonstrating ease of use for the comparison of clinical trials for ranking, prioritization for podium presentations, and publication in high impact journals. Additionally, the calculator can be used to establish priori intended enrollment demographics of clinical trials, likely improving the implementation of U.S. FDA required diversity plans as presented in the FDORA act.
Ranger:Iqvia: Ended employment in the past 24 months. Birhiray: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; 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.
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