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Selection of Patients in Ongoing Clinical Trials on Lung Cancer
Karlijn J G Schulkes1, Cindy Nguyen2, Frederiek van den Bos3
1Department of Internal Medicine, Diakonessenhuis Utrecht, Bosboomstraat 1, 3582 KE, Utrecht, The Netherlands. kschulkes@diakhuis.nl.
Background:
Lung cancer is predominantly a disease of the elderly: half of all newly diagnosed patients are over 70 years old. Older patients and those with comorbidities are underrepresented in clinical trials; scientific communities have addressed this issue since the end of the 20th century. We set out to determine the characteristics of the selection of patients in lung cancer trials that are currently recruiting.
Methods:
We searched The United States National Institutes of Health (NIH) clinical trial registry ( www.clinicaltrials.gov ) on April 23, 2015 for currently recruiting phase I, II, or III clinical trials in lung cancer. Trial characteristics and study objectives were extracted from the registry website.
Results:
Of the 419 trails selected in this overview, 88 % explicitly or implicitly excluded elderly patients. Patients were excluded based on stringent organ selection in 76 % of the trials, based on performance status (57 %) and based on age (13 %). The median number of placed restrictions per trial was seven. In the 2 % of the trials that were exclusively designed for elderly patients only fit patients were included.
Conclusion:
In this overview of current lung cancer trials registered in the NIH clinical trial registry, we found that elderly patients and those with comorbidities are often excluded from participation in clinical trials. Therefore, it is difficult for physicians and their frail patients to properly evaluate the efficacy and safety of current treatment options. More research that includes the elderly and those with comorbidities is urgently needed.
Insights
Most lung cancer clinical trials exclude elderly patients, hindering treatment evaluation for this demographic. More inclusive research is crucial for understanding treatment efficacy and safety in older adults with comorbidities.
Area of Science:
- Oncology
- Geriatric Medicine
- Clinical Trial Design
Background:
- Lung cancer disproportionately affects individuals over 70 years old.
- Older patients and those with comorbidities are historically underrepresented in clinical trials.
- Addressing this underrepresentation has been a focus since the late 20th century.
Purpose of the Study:
- To analyze patient selection criteria in current lung cancer clinical trials.
- To identify characteristics of patient exclusion in ongoing lung cancer research.
Main Methods:
- Searched the US National Institutes of Health (NIH) clinical trial registry for recruiting lung cancer trials (Phase I-III) as of April 23, 2015.
- Extracted trial characteristics and objectives from the registry.
- Analyzed exclusion criteria related to organ function, performance status, and age.
Main Results:
- 88% of 419 analyzed lung cancer trials excluded elderly patients.
- Exclusion reasons included stringent organ selection (76%), performance status (57%), and age (13%).
- Trials exclusively for elderly patients still favored only fit individuals.
Conclusions:
- Current lung cancer trials frequently exclude elderly patients and those with comorbidities.
- This exclusion complicates the assessment of treatment efficacy and safety for vulnerable populations.
- Urgent need for research that actively includes elderly patients and those with comorbidities.
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