Screening Criteria in Breast Cancer Trials: Are They Too Restrictive?

into drug, non-drug, commercial and academic. Overall, 27 patients were identified as ‘screening fails’ ,a 6.3% failure rate of those consenting to all studies. All of these ‘screening fails’ were noted in drug studies, with 24 of them (88.9%) in commercial studies, the difference compared with the non-commercial studies being significantly different (t ¼� 12.27, P < 0.001). The screening failure rate was significantly higher (34.2%) in commercial drug studies compared with 2.2% in non-commercial drug studies (t ¼� 7.23, P < 0.001). The most common cause of ‘screen failure’ was abnormal liver function tests. We assessed the reasons for exclusion from the studies and felt that for 14 patients (52%) we would have been happy to treat the patients with the trial protocol outside of a study, as safety and efficacy would not have been compromised. One of the important aspects of randomised control trials is ensuring that they are generalisable, i.e. that the result of the trial can be applied to the ‘real world’ population. There is a risk that by excluding patients after screening tests that this generalisability is being lost. It is also important to ensure that patients considering entry into a clinical trial are offered accurate information on the screening process. Most cancer drug studies are conducted in patients with metastatic disease and the timing of entry will usually be when they have either recently been diagnosed or have disease that has progressed through a previous line of therapy. This can be a difficult time and the consideration of a clinical study, often with the potential hope that a new drug offers, will require some thought from the patient. The patient information sheets often describe the screening process but fail to give any estimate of the chances of an individual patient failing to meet the eligibility criteria for study entry once they have consented to the trial. We feel that consideration should be given to making eligibility criteria less restrictive in commercial drug studies and described better in the final manuscript, as should details of excluded patients. Patient information sheets should make it clear that despite consent to the trial, a relatively high proportion of patients may become ineligible after screening tests.