Centre for Biostatistics and Clinical Trials
Centre for Biostatistics and Clinical Trials - Peter Mac Cancer Centre
| The role of the Centre for Biostatistics and Clinicals is to provide expert statistical, trial centre and data management support to research undertaken by the Peter MacCallum Cancer Institute and others. |
| Our Mission >> |
| Who we are >> |
| Our Services >> |
| Our Work >> |
| Our Funding >> |
| Our History >> |
| BaCT Services >> |
| Standards, Quality and Security >> |
| Confidentiality and Ethics >> |
| Business Practice >> |
| Research >> |
| Staff >> |
| Location >> |
| Useful Links >> |
| Our Mission |
| As active members of the global cancer research community, we strive for the world’s highest standards in data management, design, execution, analysis and interpretation of clinical and scientific cancer research. |
| Who we are |
| BaCT is a leading Australian centre for clinical trials in oncology. We are experts in all phases of clinical trials, specialist diagnostic trials and treatment planning studies. We provide randomisation, statistical and trial centre support for multicentre national and international clinical trials, for trials conducted at Peter Mac in all divisions. BaCT is the trial centre for the Australasian Leukaemia and Lymphoma Group (ALLG), the Australasian Sarcoma Study Group (ASSG) and for some trials conducted by the Trans-Tasman Radiation Oncology Group (TROG). We are experts in the design, conduct, analysis and interpretation of cancer clinical trials and retrospective studies, and experienced in the analysis of other clinical and laboratory research data. Our staff includes 5 statisticians, 2 IT specialists, 17 data managers and a management team. We also house the ALLG operations office. |
| Our Services |
| External Consultation We provide expert analysis of clinical trials for hospitals and research centres on a contract consulting basis, and undertake analysis and specialised statistical work for institutions and pharmaceutical companies on a negotiated contract basis. BaCT is the only major unit of its kind in an Australian hospital. |
| Our Work [For the year ending September 2008] |
| BaCT staff have collaborated on over 200 published papers. |
| Clinical Trials |
| In the past year, BaCT has been involved in 119 clinical trials. In 84 of these, BaCT was the trial centre (17 phase III, 49 phase II and 18 phase I, pilot or other). The remaining 35 involved study coordination only. Ninety-three of the 119 trials were multicentre trials. All clinical trials supported by BaCT during this period were investigator-initiated. BaCT coordinated 19 ALLG trials active or undergoing follow-up, 1 ASSG active trial and a further six ALLG trials and 1 ASSG trial in development. BaCT was also the Trial Centre for 11 (about half of all) TROG trials, one Australasian Lung Trials Group trial and one ANZ Melanoma Trials Group trial. BaCT also acts as the Australian coordinating centre for a number of trials sponsored by international cooperative cancer trials groups. Other projects this year include retrospective studies (19), other clinical research (23), and others, including quality assurance studies (19). CTDU (Clinical Trials Development Unit), a new joint venture between BaCT and the CTC (NHMRC Clinical Trials Centre at University of Sydney), funded by Cancer Australia, will support the concept development of new trials from collaborative oncology groups throughout Australia. CTDU will support cancer clinical trials undertaken or coordinated by new national cancer cooperative groups. |
| Our Funding |
| BaCT receives hospital funding for in-house research projects. All other projects—those involving non-Peter Mac patients or investigators—require external funding (at a Peter Mac cost-neutral rate) to support BaCT’s involvement. This funding is provided by the investigators, who enlist BaCT’s support via project-associated grants (eg. NHMRC and Cancer Councils), Cooperative Group funds, and pharmaceutical companies. (BaCT bases its costings on a detailed project effort-logging database.) |
| Our History |
| The centre has had a long history of involvement in multi-centre clinical trials, since Dr Jane Matthews became the statistician for the newly formed Australian and New Zealand Lymphoma Group (ANZLG). This group later merged with the Australian Leukaemia Study Group (ALSG) to become the ALLG. BaCT is still playing a major role as Trial Centre for the ALLG and coordinates many TROG studies. BaCT had its origins in 1971, when Dr Matthews was appointed as a full-time statistician at Peter Mac, with a staff of three. In 1978 the Computer and Bio-Statistical Service (COMPSTAT) was formed, with Dr Ken Koschel as Director and Dr Matthews as Deputy. Research data had been collected by staff in Medical Records but, by 1986, Peter Mac’s growing commitment to clinical research led to a distinct ‘Statistical Centre’. This gave Peter Mac’s statisticians and data managers, who had always worked closely, their own centre, with Dr Matthews as Director. She remained at the helm until 2000, when Dr Richard Fisher became Director. In 2004, the centre was renamed ‘The Centre for Biostatistics and Clinical Trials’. Our new Director is Dina Neiger, PhD. |
| BaCT Services |
| Design of clinical trials, advice on protocols, sample size and power calculations. Statistical analysis of data from clinical and scientific studies. Comprehensive written interpretative reports. Design of data collection forms for trials, retrospective studies, prospective databases and surveys. Preparation of randomisation charts and computer-based patient allocation systems. Allocation designs include adaptive biased coin and urn randomisation and dynamic minimisation techniques. Telephone registration and randomisation of patients on clinical trials. Creation of scientific and administrative databases. Expertise in database software. Intelligent data entry. Site liaison during trial start up, conduct and closeout., including ethics submissions and protocol specific training. Data collation, checking and clarification with clinicians, nurses and data managers. Organisation of collaborative meetings and preparation of newsletters for trial investigators. Maintenance of collaborative web sites. Assistance with preparation of manuscripts, including detailed review of drafts, preparation of graphs, and presentation of manuscripts in a form acceptable to journals. Advice on methods of statistical analysis and development of new methods. Critical review of manuscripts and publications. |
| Standards, Quality Control and Security |
| Laws and regulations of the relevant countries are followed; these include the TGA Notes for Guidance on Good Clinical Practice, the NHMRC National Statement on Ethical Conduct in Human Research, Australian Code for the Responsible Conduct of Research, Medsafe New Zealand Regulatory Guidelines for Medicines and the ICH Guidelines for Good Clinical Practice. Data entered into computer databases are independently checked using complete visual comparison or double data entry before analysis. Comprehensive computer data checks are implemented in each database. Data are rigorously checked by statisticians for consistency and validity prior to analysis. New statistical software is validated by manual calculation, comparison with computer programs developed by staff or comparison with reliable software. All statistical reports are checked by the Director or a nominee. Trial records are securely stored within the centre, which is kept locked whenever staff are absent. Computers are password protected and are maintained with current virus protection software. All databases are stored on a central server and backed up by Peter Mac Information Communication Technology (ICT) staff daily. All records relating to clinical trials are retained for 15 years. |
| Confidentiality and Ethics |
| All patient records are kept confidential, with access restricted to investigators and trial sponsors for data verification, clarification and reporting purposes. Confidentiality is maintained for all protocols and trial documentation, with access restricted to the relevant investigators, trial group or sponsoring companies. All clinical trials require approval from institutional ethics committees. |
| Business Practice |
| BaCT acts a business unit of Peter Mac. All money earned from external contracts is paid to the Peter Mac, not to individual staff members. Normally work is done on a fixed-price basis with detailed written quotations submitted prior to commencement. Work can be done on an hourly basis if requested. |
| A Biostatistician … |
|
| A Trial Centre Data Manager … |
|
Research |
| Collaborative |
| Data Managers and statisticians collaborate with investigators from Peter Mac or from research groups who have a relationship with the Centre (especially the Australasian Leukaemia and Lymphoma Group and the Trans-Tasman Radiation Oncology Group). Centre staff have collaborated in the research and publication of a number of manuscripts. |
| Biostatistical |
| The statistical research interests of the Centre include survival analysis and clinical trial methodology. Specific interests include Phase II clinical trial design, rules for monitoring toxicity, stratification in survival studies, design issues in heterogeneous populations, exploratory data analysis, interpretation of negative trials and competing risks analysis. |
| Publications by the Centre for Biostatistics and Clinical Trials |
| 2006 |
|
| 2007 |
|
| 2008 |
|
| 2009 |
|
Staff |
| Ms Dina Neiger PhD, Director A/Prof Richard Fisher MB, BS, PhD, Senior Biostatistician Alvin Milner PhD, Senior Biostatistician/IT Manager Mr Alan Herschtal BSc, BE, DipAppSc, Biostatistician Marianne Hundling Clinical Trials Program Manager Grad Dip Clin Epi Graeme Bird, Business Manager Linas Silva BSc, Analyst/Programmer Ms Jennifer Beresford MSc, Programmer Analyst/Biostatistician |
| Trial Centre Data Managers |
| Ruth Columbus PhD Ms Linda Cowan BSc(Hons) Ms Joanne Dean BAppSc, MPH Ms Juliana Di Iulio BAppSc, BSc, PhD Ms Bereha Khodr PhD Ms Narmartha Kuru BSc(MedSci), BSc(Hons), PhD Ms Poppy Kypreos BSc(Psych) Ms Anetta Matera MBiochem Ms Bev McClure BSc(Hons), Dip Comp Sc, Dip Ed, MAACB Ms Sarah McInnes BA, BSc(Hons) Ms Theresa Morgan PhD Ms Cattram Nguyen BA, BSc(Hons) Ms Christine Russell BSc(Hons) Ms Janani Sivasuthan MSc Ms Janey Stone Ms Marijana Vanevski BSc(Hons) Mr Glen Wiesner PhD |
| Administration |
| Ditas Sioco |
| Julie Umek, BA(Hons) |
| Australian Leukaemia & Lymphoma Group Operations Office |
| Mr David Ridler, Business Manager Delaine Smith, Operations Manager Megan Sanders, Protocol Development Coordinator Ms Dilupa Uduwela, Administration & Events Officer |
| Location |
| Centre for Biostatistics and Clinical Trials (BaCT) Level 2, No. 10 St Andrew’s Place, East Melbourne |
| Useful Links |
| Cancer Australia >> |
| Victorian Cancer Agency >> |
| Australasian Leukaemia and Lymphoma Group [ALLG] >> |
| Trans-Tasman Radiation Oncology Group (TROG) >> |
| NHMRC >> |
| Australasian Health & Research Data Managers' Association >> |
| Eastern Cooperative Oncology Group (ECOG) >> |
| European Organization for Research and Treatment of Cancer (EORTC) >> |
| FDA Centre for Drug Evaluation and Research (USA) >> |
| National Institutes of Health - National Cancer Institute Cancer therapeutics Evaluation Program >> |
| Therapeutic Goods Administration >> |
| World Medical Association Declaration of Helsinki - Ethical principles for medical research involving humans >> |
| International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - ICH Harmonised Tripartite Guideline - Guideline for Good Clinical Practice >> |
