Document Classification

Section Type: CONCLUSIONS

Text: At least seven important lessons have been learned from the MOTHER study : (i) an interdisciplinary focus improves the design and methods of a randomized clinical trial ; (ii) multiple sites in a clinical trial present continuing challenges to the investigative team due to variations in recruitment, patient populations and hospital practices that, in turn, differentially impact recruitment rates, treatment compliance and attrition ; (iii) study design and protocols must be flexible in order to meet the unforeseen demands of both research and clinical management ; (iv) staff turnover needs to be addressed with a proactive focus on both hiring and training ; (v) the implementation of a protocol for the treatment of a particular disorder may identify important ancillary clinical issues worthy of investigation ; (vi) timely tracking of data in a multi-site trial is both demanding and unforgiving ; and (vii) complex multi-site trials pose unanticipated challenges that complicate the choice of statistical methods, thereby placing added demands on investigators to effectively communicate their results.