title: Lessons in participant retention in the course of a randomized controlled clinical trial.
abstract: BACKGROUND
  Clinical trials are increasingly being conducted as new products seek to enter the market. Deployment of such interventions is based on evidence obtained mainly from the gold standard of randomized controlled clinical trials (RCCT). A crucial factor in the ability of RCCTs to provide credible and generalisable data is sample size and retention of the required number of subjects at completion of the follow-up period. However, recruitment and retention in clinical trials are hindered by prevalent peculiar challenges in Africa that need to be circumvented. This article shares experiences from a phase II trial that recorded a high retention rate at 14 months follow-up at a new clinical trial site.
  
  
  METHODS
  Mothers bringing children less than two months of age to the health facility were given information and invited to have their child enrolled if the inclusion criteria were fulfilled. Participants were enrolled over 8 months. Trial procedures, duration and risks/benefits were painstakingly and sequentially explained to the communities, parents and relevant relatives before and during the trial period. The proportions of participants that completed or did not complete the trial were analyzed including the reasons for failure to complete all trial procedures.
  
  
  RESULTS
  1044 individuals received information regarding the trial of which 371 returned for screening. 300 (81%) of them who fulfilled the inclusion criteria and did not meet any exclusion criteria were enrolled and 94% of these completed the trial. Consent withdrawal was the main reason for not completing the trial largely (75%) due to the father not being involved at the point of consenting or parents no longer being comfortable with blood sampling.
  
  
  CONCLUSIONS
  Participant retention in clinical trials remains a crucial factor in ensuring generalisability of trial data. Appropriate measures to enhance retention should include continuous community involvement in the process, adequate explanation of trial procedures and risks/benefits; and innovative tracing of participants adapted for the setting.
authors.affiliation: Medical Research Council Unit, P, O Box 273, Banjul, The Gambia. oidoko@mrc.gm.
authors.forename: Olubukola T
authors.initials: OT
authors.lastname: Idoko
authors.forename: Olumuyiwa A
authors.initials: OA
authors.lastname: Owolabi
authors.forename: Aderonke A
authors.initials: AA
authors.lastname: Odutola
authors.forename: Olatunde
authors.initials: O
authors.lastname: Ogundare
authors.forename: Archibald
authors.initials: A
authors.lastname: Worwui
authors.forename: Yauba
authors.initials: Y
authors.lastname: Saidu
authors.forename: Alison
authors.initials: A
authors.lastname: Smith-Sanneh
authors.forename: Abdoulie
authors.initials: A
authors.lastname: Tunkara
authors.forename: Gibbi
authors.initials: G
authors.lastname: Sey
authors.forename: Assan
authors.initials: A
authors.lastname: Sanyang
authors.forename: Philip
authors.initials: P
authors.lastname: Mendy
authors.forename: Martin O C
authors.initials: MO
authors.lastname: Ota
mesh_terms: D005500:Follow-Up Studies; D005714:Gambia; D006801:Humans; D007223:Infant; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic