SELECTION OF PATIENTS FOR RANDOMIZED TRIALS - A STUDY BASED ON THE MACOP-B VS CHOP IN NHL STUDY

Background: Selection of patients for a clinical trial is affected by awareness of the existence of the trial, interest in the study questio n and clinical practices and views of the clinicians. Aims: To investi gate the selectivity that may have occurred at Peter MacCallum Cancer Institute (PMCI) during the ANZ Lymphoma Group trial of MACOP-B vs CHO P in non-Hodgkin's lymphoma (NHL). Methods: NHL patients at PMCI in th e study period were assessed against the trial's eligibility criteria. Comparisons were made between eligible (except for consent) non-trial patients and all patients actually randomised into the trial. Results : Of 497 patients presenting during the trial period, 320 (64%) did no t meet the specified eligibility criteria, 102 (21%) were unsuitable o n other grounds (age and medical) and 75 (15%) were eligible. Of those eligible, 43 (57%) were entered into the trial and 32 (43%) were not. Four non-trial patients had inappropriate application of eligibility criteria and 13 unknown reason. Eligible non-trial patients were simil ar to trial patients in most patient and tumour characteristics and ov erall survival. Significantly more non-trial patients had higher stage disease (p = 0.02). More non-trial patients had lower grade histology , but this was not significant. Conclusions: Physician selectivity occ urred with respect to patient entry, but trial and non-trial patients were similar in most characteristics. Eligibility criteria should spec ify that patients can withstand all trial drugs and patient availabili ty for treatment and follow-up. PMCI trial accural could have been up to 33% greater. These results suggest the trial accrual period could h ave been 25% shorter. Patient entry into this trial by PMCI clinicians compared favourably with other centres.