Prevention and treatment trials need different recruitment strategies: Experience from the IBIS 1 prevention trial in Australia and New Zealand

Abstract

1030 Background: IBIS 1 is a double-blind, randomised, placebo-controlled trial to evaluate tamoxifen (20 mg, o, daily, 5 years) in preventing breast cancer (BC) in healthy women aged 35–70 at increased risk of BC. Risk was based on family history (most) and high risk benign pathology. It was anticipated that recruitment needed to go beyond conventional medical sources. The trial was conducted by the ANZ BCTG in Australia and New Zealand. Methods: : A national Recruitment Coordinator developed strategies involving print and electronic media, medical sources (GP's, breast clinics, high-risk clinics and screening) and ‘word-of-mouth’ (BC patients, relatives). Monthly print media releases or Community Service Announcements (CSA's) on radio or TV were sent widely in Australia and New Zealand. A free call number was established for enquiries which were forwarded weekly to Study Coordinators (SC's) at 19 IBIS 1 centres. SC's responded to enquiries and determined eligibility. Results: Accrual targets were exceeded with 2,674 women recruited in Australia and New Zealand, 37% of the international accrual. The ANZ BCTG participation rate per capita was one of the highest in the world for a tamoxifen breast cancer prevention trial. Annual enquiries increased from 2,155 in 1996 to 5,646 in 2000. Of women randomised, initial contact was by media 66%, medical sources 20%, friends and relatives 8% (other methods 5%). Randomisation rate varied widely amongst centres and this affected total recruitment; e.g. for Canberra Hospital, 33% of enquiries were eligible, 45% of these women were randomised (15% of initial enquiries). Factors affecting randomisation were time available for recruitment, personal contact versus mailing and distance to travel to an IBIS centre. Conclusions: Recruitment to BC prevention trials cannot rely on conventional medical sources. A coordinated media program is essential. Key factors affecting recruitment were infrastructure, coordination of publicity and centre performance. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca