S  B  P  S

 

Scottish Bell's Palsy Study

Welcome

How to Refer a Patient

What is Bell’s Palsy?

What is the S B P S?

Who’s Who

The Trial Sites

The Patient’s Experience

Graeme’s Story

House-Brackmann Scale

The Questionnaires

Documentation

Legal Stuff

Links to other web sites

Legal stuff

Sponsor

The sponsor for the Scottish Bell’s Palsy Study is the University of Dundee. This is a technical term meaning that they take primary responsibility for ensuring that the design of the study meets appropriate standards and that arrangements are in place to ensure appropriate conduct and reporting.

Funder

The SBPS is funded by the NHS HTA (Health Technology Assessment) program. Our reference number with HTA is HTA/02/09/04, and the duration of the study is from 1st November 2003 to 30th June 2007.

Ethical and management approval

As a multi-centre study the study design and processes have been approved by MREC Scotland (reference MREC/03/0/74).

Local Research Ethics Committees have also approved the study to take place in the regions of Scotland (local hospitals, GPs’ surgeries, etc).

Management committees in the contributing NHS regions in Scotland (13 of 16: Orkney, Shetland and the Western Isles are excluded because of the difficulty of supporting the study with staff at such distances).

Medicines

The Medicines and Healthcare products Regulatory Agency (MHRA, formerly the Medicines Control Agency) have approved the medicines used in the study and their purpose. These are prednisolone (approval reference MF8000/13139) acyclovir (13140) and lactose (constituting the placebo, 13141). The capsules containing the medicines are vegetarian.

Management

The Trial is overseen by a Trial Steering Committee (TSC) whose main responsibilities are to monitor and supervise the progress of the trial, to keep abreast of relevant information from other sources (such as other trials) and to advise on publicity and presentation of all aspects of the trial. The TSC comprises scientists who are experts in the management of clinical trials or who have specific knowledge and experience of Bell’s Palsy and related conditions, or both. They are

and the Trial Steering Committee also includes the Chief Investigator and one of the Principal Investigators

Safety and protection

Finally, there is a Data Monitoring and Ethics Committee (DMEC) which is established to safeguard the interests of patients participating in the study. It is the only body in the trial that has access to the unblinded comparative data (i.e. which knows who is getting which treatment). They are