The troublesome state of oncology clinical trials

Although more than two thirds of the biologics pipeline is in oncology, conducting a clinical trial continues to be troublesome. Consider these:

  • The National Cancer Institute estimates that up to 40% of oncology trials fail to achieve minimum enrollment. Covance estimates that more than 60% of phase 3 trials do not reach planned enrollment.

  • Cancer patients who live on less than $50,000 a year take part in clinical trials at a rate one third lower than those who make more. The absence of low-income participants makes researchers’ findings less representative of the general population.
  • Various surveys suggest that 50% to 80% of patients do not have any information on potential clinical trials for their condition.
  • Patients and providers often believe the default “standard of care” is better—or at least less risky—than a clinical trial.
  • Patients are often selected on the basis of comorbidities. A Duke University study found that up to 40% of patients would not have received the trial drug if they were already receiving it for a comorbidity.
  • Novel agents for cancer, such as ibrutinib, work by mechanisms distinct from chemotherapy and have shown efficacy regardless of prior regimens. But as additional drugs are approved, enrollment becomes more difficult. Studies often require participants to have either received or not received another approved drug.
  • Biomarkers are increasingly a target in oncology, and some approved drugs are accompanied by a protocol to use a biomarker or a companion diagnostic to inform use. Payers can be expected to restrict access to costly targeted treatments, but simultaneously, makers of therapies with biomarkers can expect that eligible patients who test positive for a biomarker or mutation will be approved for coverage.
  • Clinical trials are becoming more and more complex. For an average phase 3 trial, the number of endpoints and/or eligibility criteria has increased by at least 50% in the last 10 to 15 years.
  • A study in the Journal of the National Cancer Institute found that 62% or recent phase 3 oncology trials failed to achieve results with statistical significance. Failed clinical trials are a huge cost to the drug sponsors, patients, and society as a whole.

Sources:; Duke Cancer Institute; Fred Hutchinson Cancer Research Center; JAMA Oncology; Gan HK et al, J Natl Cancer Inst. 2012;104:590–598.

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