Profile of clinical trial biostatisticians and university courses to train them in South Africa

[摘要] English: Many statistical issues in the area of clinical trials are specific to this particular field. Aclinical trial biostatistician should not only be appropriately qualified in generalstatistical theory, but also be appropriately trained and experienced in the applicationof statistics to clinical trials. This thesis investigates the background and training ofstatisticians practicing in this field in South Africa. It provides an overview of thetraining that is available for clinical trial biostatisticians at universities in South Africa.Lastly, the thesis also provides recommendations for the training and development ofclinical trial biostatisticians.The methodology used for this research included a literature study regarding therequired profile (education/training, years of experience and part of the industry inwhich they are employed) of a clinical trial biostatistician, and topics of interest tosuch a biostatistician. A review of the content of statistics courses offered at SouthAfrican Universities was performed. A questionnaire survey was conducted toassess the education/training profile of clinical trial biostatisticians in South Africa andto assess the knowledge of biostatisticians in areas considered necessary to be anappropriately qualified and experienced clinical trial biostatistician as defined in theliterature.Twenty-nine respondents were considered valid clinical trial biostatisticians and werethus included in the analysis of the clinical trial biostatistician questionnaires. TwentySouth African universities were approached to provide information regarding thestatistics courses they present. Information was obtained from fourteen (70.0%) ofthese universities.The profile of clinical trial biostatisticians in South Africa, with respect to qualificationsand experience, is comparable to clinical trial biostatisticians in Europe. However,the industries in which the biostatisticians are employed differ from those that employclinical trial biostatisticians in Europe.South African clinical trial biostatisticians are not necessarily familiar with all thetopics applicable to their discipline. The areas in which they were the least familiarwere: regulatory requirements and international guidelines, statistical analysisconsiderations, reporting, and quality control and documentation. Aside fromstatistical methods which were mostly learned at university, knowledge andexperience were mostly acquired through on-the-job training followed by self-studyand reading.It is hoped that the implementation of a university programme specific to clinical trialbiostatisticians, improvements in current statistical courses, the development of aclinical trial biostatistician manual and the introduction of a medical statisticiancertification scheme, would contribute to developing what Iman (1995) is referring towhen he quotes Kettenring in saying, Industry needs holistic statisticians who arenimble problem solvers.

[发布机构] University of the Free State