Overall compliance with eligibility criteria guidelines is low for pancreatic cancer trials, according to study results published in JNCI Cancer Spectrum.1
Researchers found that, in some areas, pancreatic cancer trials are in compliance with 2017 guidelines on modernizing clinical trial eligibility criteria.2-4
However, for most of the eligibility criteria analyzed, there was no improvement from the pre-guideline era to the post-guideline era.1
For this study, researchers evaluated data from 198 pancreatic cancer trials. There were 86 trials in the pre-guideline period (from January 1, 2014, to December 31, 2017) and 112 trials in the post-guideline period (January 1, 2018, to March 1, 2022).
The researchers assessed 13 eligibility criteria and found significant improvements from the pre-guideline era to the post-guideline era for 3 criteria — HIV-positive status, prior malignancy more than 2 years ago, and concurrent malignancy that is stable and the patient is off treatment.
The proportion of trials that included HIV-positive patients increased from 8.6% pre-guidelines to 43.8% post-guidelines (P <.0001). The proportion of trials that included patients with prior cancers increased from 57.0% to 72.3% (P =.034). And the proportion of trials that included patients with a concurrent but stable malignancy increased from 2.1% to 31.1% (P <.0001).
For the remaining criteria, there were no significant improvements, as seen in the table below.
|Eligibility Criteria||Pre-Guideline Trials (n=86)||Post-Guideline Trials (n=112)||P Value|
|Performance Status of 2 Allowed||36.5%||36.2%||1.000|
|Renal Function Compliant (Use of Creatinine Clearance Only)||9.7%||9.6%||1.000|
|Reference Ranges Used for Labs Assessing Organ Function||96.6%||96.0%||1.000|
|Classification System Used for Assessing Heart Failure||53.1%||57.4%||0.702|
|Cardiac Abnormalities Specified||68.6%||59.8%||0.234|
|Prior Therapy Allowed and Exclusions Must BeSpecified||100%||94.7%||0.135|
|Time-Based Washout Period Used||60.0%||53.2%||0.480|
|Mentions Recovery from Prior Adverse Events||45.5%||37.7%||0.377|
|Brain Metastases Allowed if Stable More Than 4 Weeks||51.2%||67.6%||0.171|
“Most trials (>95%) were compliant with laboratory reference ranges, QTc cutoffs, and rationalizing excluding prior therapies both pre-/post-guidance eras,” the researchers noted. “However, overall compliance with modernized criteria remains poor. We advocate for stakeholders to update protocols and scrutinize traditionally restrictive eligibility criteria.”
1. Riner AN, Freudenberger DC, Herremans KM, et al. Call to action: Overcoming enrollment disparities in cancer clinical trials with modernized eligibility criteria. JNCI Cancer Spectr. Published online February 21, 2023. doi:10.1093/jncics/pkad009
2. Lichtman SM, Harvey RD, Damiette Smit MA, et al. Modernizing clinical trial eligibility criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction, Prior or Concurrent Malignancy, and Comorbidities Working Group. J Clin Oncol. 2017;35(33):3753-3759.
3. Uldrick TS, Ison G, Rudek MA, et al. Modernizing clinical trial eligibility criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research HIV Working Group. J Clin Oncol. 2017;35(33):3774-3780.
4. Lin NU, Prowell T, Tan AR, et al. Modernizing clinical trial eligibility criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Brain Metastases Working Group. J Clin Oncol. 2017;35(33):3760-3773.