Abstract 4344: Racial representativeness of cancer clinical trials sponsored by the National Cancer Institute compared to pharmaceutical companies
Bibliographic record
Abstract
Abstract Purpose Many clinical trials supporting new drug applications underrepresent minority patients. Trials conducted by the NCI's clinical trial network (NCTN) have greater outreach to community sites, potentially allowing better representation. We compared the representation of black patients in pharmaceutical company-sponsored cancer clinical trials to NCTN trials and the U.S. cancer population. Procedures We established a large cohort of study publications representing the results of pharmaceutical-company sponsored trials that supported new U.S. Food and Drug Administration (FDA) drug approvals from 2008-2018. NCTN trial data were from the SWOG Cancer Research Network. U.S. cancer population rates were estimated using Surveillance, Epidemiology, and End Results (SEER) survey data. We compared the proportion of black patients by enrollment year for each cancer type and overall. Comparisons between groups were conducted using tests of proportions. Results 227 trials (pharmaceutical company-sponsored trials, 74; SWOG trials, 153) comprised of 79,592 patients (pharmaceutical company-sponsored trials, 43,567; SWOG trials, 36,025) for nine specific cancer types were analyzed. Overall, the proportion of black patients was 2.9% for pharmaceutical company-sponsored trials, 8.3% for SWOG trials, and 12.1% for the U.S. cancer population (p<.001 for each pairwise comparison). For each cancer type, the proportion of black patients was statistically significantly lower for pharmaceutical company-sponsored trials compared to SWOG trials (except for melanoma) and compared to the U.S. cancer population. Conclusions The poor representation of minority groups in pharmaceutical company-sponsored trials is of vital scientific concern. These trials could support the use of new drugs with little data about efficacy or side effects in key populations. Because pharmaceutical company-sponsored trials test the newest available therapies, limited access to these trials represents a disparity in access to potential breakthrough therapies. Pharmaceutical companies could improve racial/ethnic diversity in their trials - and expand access to all patients - through increased outreach to community sites, as suggested by the findings for the NCTN trials. These results have the potential to directly influence policy, as the FDA, in partnership with the American Association for Cancer Research, is currently examining ways to improve representation of black patients in FDA registration trials. Citation Format: Joseph M. Unger, Dawn L. Hershman, Raymond U. Osarogiagbon, Anirudh Gothwal, Seerat Anand, Arvind Dasari, Michael Overnman, Jonathan M. Loree, Kanwal Raghav. Racial representativeness of cancer clinical trials sponsored by the National Cancer Institute compared to pharmaceutical companies [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 4344.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.031 | 0.084 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".