title: The challenges of long-term follow-up data collection in non-commercial, academically-led breast cancer clinical trials: the UK perspective.
abstract: BACKGROUND
  Improved survival rates in early breast cancer and the chronic nature of disease relapse result in a large cohort of patients being available for long-term follow-up (LTFUP) in randomised controlled trials. Whilst of recognised scientific value to assess long-term treatment-related sequelae, the volume of this activity can be challenging for trialists and participating sites, and comes at a considerable cost to research funders and the National Health Service (NHS). A National Cancer Research Institute Breast Clinical Studies Group supported project aimed to characterise UK LTFUP data collection procedures in order to propose improvements.
  
  
  METHODS
  Protocols and case report forms for UK non-commercial National Institute for Health Research portfolio early breast cancer randomised controlled trials were reviewed and a questionnaire sent to associated participating NHS sites. Responders were asked to give opinions on issues with follow-up and LTFUP data collection procedures and to suggest potential improvements to practice. Results were used to inform design of a proposed standard LTFUP case report form.
  
  
  RESULTS
  Thirty-four trials, involving eight Clinical Trials Units were eligible for inclusion in the review. All trials requested follow-up at least annually up to 5 years, with two-thirds requesting LTFUP after that time point. Information relating to efficacy endpoints was captured for all trials via case report forms; however, precise detail on recording of recurrence, second malignancies and death varied. Separately, questionnaires were returned from 66 NHS sites. Main concerns identified included difficulties in identifying all adverse events from hospital notes, volume of work, bureaucratic data management practices in Clinical Trials Units and perceptions of prioritisation of recruitment over follow-up.
  
  
  CONCLUSIONS
  Variation has existed with respect to detail of LTFUP information requested for UK trials. Improved communication, simplification and standardisation of data and associated collection methods are possible without compromising data requirements for efficient and effective trial reporting. Future use of routinely collected data, captured via electronic means, could transform practices and alleviate resource usage.
authors.affiliation: ICR Clinical Trials & Statistics Unit (ICR-CTSU), Division of Clinical Studies, The Institute of Cancer Research, Sir Richard Doll Building, Cotswold Road, London SM2 5NG, UK. Lucy.Kilburn@icr.ac.uk.
authors.forename: Lucy S
authors.initials: LS
authors.lastname: Kilburn
authors.forename: Jane
authors.initials: J
authors.lastname: Banerji
authors.forename: Judith M
authors.initials: JM
authors.lastname: Bliss
mesh_terms: D000047:Academies and Institutes / Q000592:standards; D001943:Breast Neoplasms / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003625:Data Collection / Q000592:standards; D005260:Female; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards; D012107:Research Design / Q000592:standards; D013222:State Medicine / Q000592:standards; D011795:Surveys and Questionnaires; D017741:Survivors; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom