D.R.I.V.E. is our strategy for promoting representative enrollment in clinical trials, to address the inherent issues of safety and lack of efficacy data of non-enrolled populations created when clinical studies are conducted in populations that do not overlap with the target group for whom these products /devices are intended for treat in the clinical setting. Generalizability refers to inferring the average effect of a treatment from a biased non-overlapping study population to the entire population and transportability refers to the ability to make an inference of a treatment effect when the study group and target treatment groups do not overlap. Due to the paramount importance of these principles, we define “clinical trial excellence” as studies meeting these goals.

Historical migration, the enslavement of Africans, the dislocation of native populations, in addition to ongoing voluntary migration, enhanced by ease of travel, and mixed relationships have created very diverse world populations. Additionally, rural and urban transmigrations have continued to both create isolated mixed person populations. Race and its resultant polymorphisms, with differences in dietary practices due to ethnic backgrounds and places of residence, including rural and urban and the resultant gastrointestinal microbiome differences, which create human epigenetic differences ultimately lead to varied biologic effects in humans. Current clinical trial practices are based on statistical methods to establish the average clinical efficacy and safety for the studies population, which ultimately leads to regulatory agency approval. However, inherent in this methodology is generating unbiased, reproducible and reliable clinical data applicable to persons for whom these agents are used in clinical practice. Well-designed studies with diverse enrollment would produce clinically generalizable and transportable data, whereas studies lacking in diversity are inherently unsafe. Currently most studies resulting in drug approvals for cancer patients in the United States and globally have been lacking in meeting this basic tenet of safety and established efficacy standards.

The D.R.I.V.E. Initiative 2025 is an effort to highlight, promote and adopt practical strategies for achieving clinical trial excellence in cancer research studies.