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Table 1 Reasons for not participating in a therapeutic clinical trials by domain and ethical factors

From: Removing barriers to participation in clinical trials, a conceptual framework and retrospective chart review study

  Domain Ethical requirements[19] Ethical principles[18] Sample reasons for not participating in a clinical trial[15, 22, 41, 52]
Patient-trial fit
Scientific oversight [10, 53] Institution 5-Independent review Beneficence Cannot identify patients
Patients seek services elsewhere
2-Scientific validity Cannot enroll enough patients
Unavailability
No measureable/confirmable disease
Availability by disease characteristics [1, 20] 1-Social value Justice No testable treatments for the disease, stage, or other characteristics
Investigators
Eligibility [9] 3-Fair subject selection justice Prior tumor, second cancer, metastases
Precluded by prior or current treatment or co-morbid conditions
Beneficence Poor performance status
Asymptomatic
Study demands
Physician triage [25] Physician 4-Favorable risk-benefit ratio Treatment not tolerated, died soon, disease is too advanced
Quality of life issues
Life expectancy is limited
Need for immediate treatment
Physician preference/judgment
Opportunity
Discussion of trials [27, 33, 36, 37] Physician 6-Informed and voluntary consent Respect for persons Physician judged compliance issues
Doctor-patient communication issues
Interest and willingness [24, 29, 30, 39] Patient 6-Informed and voluntary consent Respect for persons Treatment preference /placebo
Minimal care: symptomatic treatment only, supportive or hospice care desired, refused further staging
Not interested
Barriers: distant from clinic [5], financial, insurance [48], personal circumstances
Second opinion only, return to home physician, no ongoing relationship
Acceptance
Patient consent [45] Patient 6-Informed and voluntary consent Respect for persons Fear of randomization
Fear of side effects
Negative aspects of a trial participation, distance
Patient enrollment Investigator 7-Respect for enrolled subjects Patient failed trial screening protocol
     Withdrawal