title: Setting up a clinical trial in care homes: challenges encountered and recommendations for future research practice.
abstract: BACKGROUND
  Older adults in care homes have increasingly complex health care needs, and care provision should be evidence-based whenever possible. However, recruitment of frail, older people to research is a complex process and often results in care home residents being excluded from research participation. This paper draws on the experience of setting up a randomised controlled trial to determine the effectiveness of probiotics on antibiotic-associated diarrhoea in care home residents [Probiotics for Antibiotic Associated Diarrhoea in Care Homes (PAAD) Study] in Wales.
  
  
  RESULTS
  Significant challenges were encountered setting up a clinical trial in care homes. There were a number of barriers and facilitative factors encountered that were unique to this research setting. The classification of the study intervention (a widely available food supplement with a low risk safety profile) as an investigational medicinal product, with the associated requirements including obtaining statutory approvals and research governance, had a major impact.
  
  
  CONCLUSIONS
  The process for setting up a clinical trial of an investigational medicinal product in care homes has been more complex and time consuming than the process for setting up an observational study in the same setting, and clinical trials in other health care settings. We recommend regulatory changes to ensure approvals processes are more proportionate to risk and context, to ensure that care home residents have the opportunity to participate in research and are able to help generate much needed evidence to underpin care. Recommendations made may inform future research practice.
  
  
  BACKGROUND
  ISRCTN 25324586.
authors.affiliation: South East Wales Trials Unit, School of Medicine, Cardiff University, 7th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. ShepherdVL1@cardiff.ac.uk.
authors.forename: Victoria
authors.initials: V
authors.lastname: Shepherd
authors.affiliation: South East Wales Trials Unit, School of Medicine, Cardiff University, 7th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. jacquinuttall@hotmail.com.
authors.forename: Jacqui
authors.initials: J
authors.lastname: Nuttall
authors.affiliation: South East Wales Trials Unit, School of Medicine, Cardiff University, 7th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. HoodK1@cardiff.ac.uk.
authors.forename: Kerenza
authors.initials: K
authors.lastname: Hood
authors.affiliation: Nuffield Department of Primary Care Health Sciences, University of Oxford, New Radcliffe House, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6NW, UK. christopher.butler@phc.ox.ac.uk.|Cochrane Institute of Primary Care and Public Health, School of Medicine, Cardiff University, 5th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. christopher.butler@phc.ox.ac.uk.
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Butler
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects; D003967:Diarrhea / Q000139:chemically induced / Q000178:diet therapy*; D015507:Drugs, Investigational / Q000627:therapeutic use*; D005260:Female; D006707:Homes for the Aged / Q000941:ethics*; D006801:Humans; D008297:Male; D009735:Nursing Homes / Q000941:ethics*; D018579:Patient Selection / Q000941:ethics*; D019936:Probiotics / Q000627:therapeutic use*; D012107:Research Design; D014852:Wales
chemical_list: D000900:Anti-Bacterial Agents; D015507:Drugs, Investigational