Profile of clinical trial biostatisticians and university courses to train them in South Africa
| dc.contributor.advisor | Joubert, G. | |
| dc.contributor.advisor | Schall, R. | |
| dc.contributor.author | Rossouw, Sharon Lynne | |
| dc.date.accessioned | 2017-06-07T07:01:24Z | |
| dc.date.available | 2017-06-07T07:01:24Z | |
| dc.date.issued | 2003-11 | |
| dc.description.abstract | English: Many statistical issues in the area of clinical trials are specific to this particular field. A clinical trial biostatistician should not only be appropriately qualified in general statistical theory, but also be appropriately trained and experienced in the application of statistics to clinical trials. This thesis investigates the background and training of statisticians practicing in this field in South Africa. It provides an overview of the training that is available for clinical trial biostatisticians at universities in South Africa. Lastly, the thesis also provides recommendations for the training and development of clinical trial biostatisticians. The methodology used for this research included a literature study regarding the required profile (education/training, years of experience and part of the industry in which they are employed) of a clinical trial biostatistician, and topics of interest to such a biostatistician. A review of the content of statistics courses offered at South African Universities was performed. A questionnaire survey was conducted to assess the education/training profile of clinical trial biostatisticians in South Africa and to assess the knowledge of biostatisticians in areas considered necessary to be an appropriately qualified and experienced clinical trial biostatistician as defined in the literature. Twenty-nine respondents were considered valid clinical trial biostatisticians and were thus included in the analysis of the clinical trial biostatistician questionnaires. Twenty South African universities were approached to provide information regarding the statistics courses they present. Information was obtained from fourteen (70.0%) of these universities. The profile of clinical trial biostatisticians in South Africa, with respect to qualifications and experience, is comparable to clinical trial biostatisticians in Europe. However, the industries in which the biostatisticians are employed differ from those that employ clinical trial biostatisticians in Europe. South African clinical trial biostatisticians are not necessarily familiar with all the topics applicable to their discipline. The areas in which they were the least familiar were: regulatory requirements and international guidelines, statistical analysis considerations, reporting, and quality control and documentation. Aside from statistical methods which were mostly learned at university, knowledge and experience were mostly acquired through on-the-job training followed by self-study and reading. It is hoped that the implementation of a university programme specific to clinical trial biostatisticians, improvements in current statistical courses, the development of a clinical trial biostatistician manual and the introduction of a medical statistician certification scheme, would contribute to developing what Iman (1995) is referring to when he quotes Kettenring in saying, "Industry needs holistic statisticians who are nimble problem solvers". | en_ZA |
| dc.description.abstract | Afrikaans: Baie statistiese kwessies op die gebied van kliniese proewe is van spesifieke toepassing op hierdie veld. 'n Kliniese proef biostatistikus moet nie net toepaslik gekwalifiseer wees rakende algemene statistiese teorie nie, maar moet ook genoegsaam opgelei en ervare wees ten opsigte van die toepassing van statistiek in kliniese proewe. Hierdie verhandeling ondersoek die agtergrond en opleiding van statistici werksaam op hierdie gebied in Suid-Afrika. 'n Oorsig word verskaf van die opleiding wat beskikbaar is vir kliniese proef biostatistici by universiteite in Suid- Afrika. Laastens word aanbevelings gemaak vir die opleiding en ontwikkeling van kliniese proef biostatistici. Die metodologie wat vir hierdie navorsing gebruik is, het 'n literatuurstudie rakende die vereiste profiel van 'n kliniese proef biostatistikus (opleiding, ondervindingsjare en gedeelte van die bedryf waar hulle in diens is), asook sake wat vir 'n biostatistikus van belang is, ingesluit. 'n Oorsig oor die inhoud van statistiekkursusse wat by Suid- Afrikaanse universiteite aangebied word, word gegee. 'n Vraelysopname is uitgevoer om die opleidingsprofiel van kliniese proef biostatistici in Suid-Afrika te ondersoek. Die vakgebiede wat as noodsaaklik beskou word ten einde na behore gekwalifiseerd en ervare as 'n kliniese proef biostatistikus te wees is in die literatuur geïdentifiseer en die kennis van biostatistici is hiervolgens geëvalueer. Nege-en-twintig respondente is as geldige kliniese proef biostatistici beskou en is derhalwe ingesluit in die analise van die kliniese proef biostatistikus vraelys. Twintig Suid-Afrikaanse universiteite is genader vir inligting oor die statistiekkursusse wat aangebied word. Inligting is van veertien (70%) van hierdie universiteite ontvang. Die profiel van kliniese proef biostatistici, met betrekking tot hulle kwalifikasies en ondervinding, is vergelykbaar met dié van kliniese proef biostatistici in Europa, maar die spesifieke deel van die industrie waarin hierdie biostatistici werksaam is, verskil van die wat in Europa werk. Suid-Afrikaanse kliniese proef biostatistici is nie noodwendig vertroud met al die onderwerpe wat van toepassing is op hul dissipline nie. Die gebiede waarmee hulle die minste vertroud was, was die wetlike vereistes en internasionale riglyne, statistiese analise oorwegings, verslaglewering, en kwaliteitskontrole en dokumentasie. Afgesien van die kennis van statistiese metodes wat deur studie aan universiteite verkry is, is kennis en ondervinding hoofsaaklik deur indiensopleiding, self-studie en eie nalees verkry. Dit word gehoop dat die implementering van "n universiteitsprogram spesifiek gemik op kliniese proef biostatistici, verbeteringe aan statistiekkursusse wat tans aangebied word, die ontwikkeling van "n handleiding vir kliniese proef biostatistici en die totstandkoming van "n program vir die sertifisering van mediese statistici daartoe sal lei dat dit waarna Kettenring verwys as hy skryf: "Industry needs holistic statisticians who are nimble problem solvers" waar sal word. | af |
| dc.identifier.uri | http://hdl.handle.net/11660/6341 | |
| dc.language.iso | en | en_ZA |
| dc.publisher | University of the Free State | en_ZA |
| dc.rights.holder | University of the Free State | en_ZA |
| dc.subject | Clinical trial | en_ZA |
| dc.subject | Biostatistician | en_ZA |
| dc.subject | Training | en_ZA |
| dc.subject | Experience | en_ZA |
| dc.subject | Knowledge | en_ZA |
| dc.subject | Medical statistics | en_ZA |
| dc.subject | Statisticians -- Training of | en_ZA |
| dc.subject | Medical statistics -- Statistical methods | en_ZA |
| dc.subject | Dissertation (M.Med.Sc. (Biostatistics))--University of the Free State, 2003 | en_ZA |
| dc.title | Profile of clinical trial biostatisticians and university courses to train them in South Africa | en_ZA |
| dc.type | Dissertation | en_ZA |