title: Selection of Patients in Ongoing Clinical Trials on Lung Cancer.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Internal Medicine, Diakonessenhuis Utrecht, Bosboomstraat 1, 3582 KE, Utrecht, The Netherlands. kschulkes@diakhuis.nl.
authors.forename: Karlijn J G
authors.initials: KJ
authors.lastname: Schulkes
authors.affiliation: Department of Internal Medicine, Diakonessenhuis Utrecht, Bosboomstraat 1, 3582 KE, Utrecht, The Netherlands.
authors.forename: Cindy
authors.initials: C
authors.lastname: Nguyen
authors.affiliation: Department of Internal Medicine, Haga Hospital, Leyweg 275, 2545 CH, The Hague, The Netherlands.
authors.forename: Frederiek
authors.initials: F
authors.lastname: van den Bos
authors.affiliation: Department of Pulmonology, Diakonessenhuis Utrecht, Utrecht, The Netherlands.
authors.forename: Leontine J R
authors.initials: LJ
authors.lastname: van Elden
authors.affiliation: Department of Geriatric Medicine, Diakonessenhuis Utrecht, Utrecht, The Netherlands.
authors.forename: Marije E
authors.initials: ME
authors.lastname: Hamaker
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic / Q000379:methods*; D015897:Comorbidity; D006304:Health Status; D006801:Humans; D008175:Lung Neoplasms / Q000628:therapy*; D008875:Middle Aged; D018579:Patient Selection; D012042:Registries; D055815:Young Adult
keywords: Elderly; Geriatric; Lung cancer; Pulmonology