title: How to substantially increase recruitment in cancer trials in New Zealand.
abstract: Recruitment rates into cancer treatment trials are generally very low, both in New Zealand and internationally. This viewpoint article suggests that recruitment rates could be substantially increased by considering all patients newly diagnosed with cancer to be automatically eligible for randomisation if experimental treatments were available under study protocols for patients with their type of cancer. Patients randomised to be offered the experimental treatment would be approached for consent to receive it, whereas patients randomised not to be offered this treatment would continue to receive standard treatment (thus serving as the control group) and not be approached for consent. Routine adoption of this approach, known as "post-randomisation consent" or "pre-randomisation", would require public consultation and "societal consent". While this proposal is not without significant challenges and potential disadvantages, an informed public discussion on the subject would seem worthwhile given the potential for increasing patient access to new cancer treatments and advancing medical science.
authors.affiliation: Centre for Assessment and Prioritisation, Department of Public Health, University of Otago - Wellington, PO Box 7343, Wellington, New Zealand. david.hadorn@otago.ac.nz.
authors.forename: David
authors.initials: D
authors.lastname: Hadorn
authors.forename: Nick
authors.initials: N
authors.lastname: Wilson
authors.forename: Richard
authors.initials: R
authors.lastname: Edwards
authors.forename: Tony
authors.initials: T
authors.lastname: Blakely
authors.forename: Diana
authors.initials: D
authors.lastname: Sarfati
mesh_terms: D001294:Attitude to Health; D035843:Biomedical Research; D006801:Humans; D007258:Informed Consent; D009369:Neoplasms; D009520:New Zealand; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design