# Revisiting Prior Cancer as an Exclusion Criterion for Cancer Clinical Trials

> **NIH NIH R01** · UT SOUTHWESTERN MEDICAL CENTER · 2021 · $657,592

## Abstract

Project Description (abstract)
Despite intensive efforts to increase participation, fewer than two percent of US adults are enrolled in clinical
trials. More than 40% of National Cancer Institute (NCI)-sponsored trials fail to complete accrual. Clinical trial
eligibility criteria present one of the most significant barriers to study accrual and one of the few accrual
factors directly controlled by investigators and sponsors. Prior cancer is a widespread exclusion criterion in
cancer trials. Our study will provide novel evidence required to objectively reconsider the exclusion of cancer
survivors with newly diagnosed (incident) cancer from cancer clinical trials. Specifically, in two aims, we will
1) systematically review how this criterion is incorporated in NCI-sponsored trial protocols and 2) evaluate the
impact of prior cancer on cause-specific and all-cause mortality for older patients with six common and deadly
cancers: breast, colorectal, kidney, liver, Non-Hodgkin’s lymphoma, and pancreas. We will conduct these
analyses using sophisticated epidemiologic and statistical methods applied to high-quality, population-based
SEER-Medicare data. We will quickly disseminate findings via our External Advisory Board comprised of
national leaders in clinical trials and patient advocates. The potential impact of this work to change research
and practice is enormous. More than one third of all people diagnosed with cancer in the US are diagnosed
with one of the six cancer types in this proposal; and of these, an estimated 13.5% of those over age 65 years
have a prior cancer history and thus are at risk of systematic exclusion from cancer trials.

## Key facts

- **NIH application ID:** 10249231
- **Project number:** 5R01CA229834-04
- **Recipient organization:** UT SOUTHWESTERN MEDICAL CENTER
- **Principal Investigator:** Sandi Leigh Pruitt
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $657,592
- **Award type:** 5
- **Project period:** 2018-09-14 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10249231

## Citation

> US National Institutes of Health, RePORTER application 10249231, Revisiting Prior Cancer as an Exclusion Criterion for Cancer Clinical Trials (5R01CA229834-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10249231. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*