Call to action: overcoming enrollment disparities in cancer clinical trials with modernized eligibility criteria.
Andrea N RinerDevon C FreudenbergerKelly M HerremansVignesh VudathaDaniel W NealThomas J GeorgeJose G TrevinoPublished in: JNCI cancer spectrum (2023)
Traditional clinical trial eligibility criteria restrict study populations, perpetuating enrollment disparities. We aimed to assess implementation of modernized eligibility criteria guidelines among pancreatic cancer (PC) clinical trials. Interventional PC trials in the United States since January 1, 2014, were identified via clinicaltrials.gov with December 31, 2017, as the transition for pre- and postguidance eras. Trials were assessed for guideline compliance and compared using Fisher exact test. In total, 198 trials were identified: 86 (43.4%) were pre- and 112 (56.6%) postguidance era. Improvements were seen in allowing patients with history of HIV (8.6% vs 43.8%; P < .0001), prior cancer (57.0% vs 72.3%; P = .034), or concurrent and/or stable cancer (2.1% vs 31.1%; P < .0001) to participate. Most (>95%) trials were compliant with laboratory reference ranges, QT interval corrected for heart rate (QTc) cutoffs, and rationalizing excluding prior therapies both pre- and postguidance eras. However, overall compliance with modernized criteria remains poor. We advocate for stakeholders to update protocols and scrutinize traditionally restrictive eligibility criteria.
Keyphrases
- clinical trial
- papillary thyroid
- heart rate
- squamous cell
- heart rate variability
- blood pressure
- healthcare
- hepatitis c virus
- primary care
- lymph node metastasis
- health insurance
- hiv infected
- randomized controlled trial
- double blind
- hiv positive
- childhood cancer
- clinical practice
- hiv aids
- phase iii
- open label
- quality improvement
- south africa
- drug induced
- genetic diversity