Clinical Trials

The clinical trials management service performs a full range of tasks associated with all aspects of medical research. These include:

• Quotations for statistical analysis for inclusion in project proposals
• Statistical advice on required sample sizes
• Assessment of study protocol and of the possible need for a pilot study
• Statistical reviews of previous studies and of relevant literature
• Advice on design of questionnaires/clinical report forms
• Data collation
• Construction of data coding schemes
• Data entry, or advice on the use of an appropriate spreadsheet or database should the client prefer to perform data entry in-house
• Accessing large computerised databases for data retrieval
• Data validation

Following data entry and validation, statistical analyses are performed on platforms ranging from a Hewlett Packard 9000/870 mainframe running HP-UX (Unix) to Macintoshes and PCUs running Windows. The Statistics Advice Centre has a range of statistics software packages at its disposal, ranging from simple epidemiological and graphical products, such as Excel, Epi-Info, CricketGraph and StatView, through to sophisticated statistical packages, such as SAS, SPSS, GLIM and Minitab. SAS is the product of choice for most projects, with its broad catalogue of statistical procedures and excellent graphical capabilities. These features, together with its Applications Facility for constructing menu-driven screens (which can be tailored to the requirements of the client), provide a suitable and user-friendly working environment.

Recent examples of medical projects

In addition to clinical trials, the Statistics Advice Centre undertakes many other types of project associated with medical statistics. Here are some recent examples:

1. A clinical trial to compare the efficacy of 2 wound dressings: The British subsidiary of a large American pharmaceutical corporation required a comprehensive statistical report on a clinical trial comparing the effectiveness of 2 different types of wound dressing in the treatment of leg ulcers. Data entry, data validation, and statistical analyses, including graphical displays, were performed.
2. Construction of a push button statistical reporting system: In order to deal with frequent requests from internal medical research staff at the University of Surrey, a push-button statistical reporting system was developed to handle efficiently the most common types of analyses required.
3. Simultaneous interrogation of five downloaded data sets: A major research project was undertaken to assess the workload at clinics for sexually transmitted diseases in the light of the AIDS epidemic. A large and complex database was downloaded from a major London clinic's patient administration system. After intensive statistical analysis the most accurate marker of the clinic's increasing workload was identified. The results were published in an appropriate medical journal.