How to improve accrual to clinical trials of symptom control 2: design issues.

Overview

The major reason that clinical trials in integrative oncology fail is that inadequate numbers of patients are accrued. One important cause of inadequate accrual is eligibility criteria that are overly restrictive. Investigators should critically examine every single inclusion or exclusion criterion to determine whether possible benefits to the study clearly outweigh harms in terms of reduced accrual. Accrual will also be harmed if the burdens for participation--traveling to appointments, completing questionnaires--are excessive compared with the benefits for patients. In a traditional randomized trial, half of participants do not receive treatment, reducing the benefits expected by any patient. This can be offset by guaranteeing free treatment to patients in the control group after they have completed the study. Patient burden can be reduced by limiting the number of hospital visits and avoiding excessive numbers of questionnaires.