Draft 1

I am a fourth year Pharmacy student at the University of Wolverhampton and I am conducting research with the aim of improving the knowledge of Rituximab use for cancer indications outside the UK and to investigate the opinions of non UK-based oncology/haematology pharmacists on it's use.

If you have any queries regarding the research or wish to withdraw your response please do not hesitate to contact me via email. My email address is [email protected]. Alternatively, you may contact my project supervisor (Bruce Burnett) via email at [email protected].

The following information will contextualise the research and includes information regarding the research background and aims and also your role if you choose to participate in this research.

Research background and aims
Rituximab is a widely used chimeric monoclonal antibody and in clinical practise it is administered according to infusion schedules or protocols. The summary of product characteristics (SPC) outlines the manufacturer’s recommended infusion protocol on which the licence is based. The SPC’s first infusion protocol is typically over 5 – 6 hours and for subsequent infusions is reported to be up to 4 hours.

A recent literature review found the SPC first infusion protocol is utilised for the first Rituximab infusion in cancer patients and should a significant first infusion reaction not occur some centres offer rapid infusion over 90 or 60 minutes. Therefore the current evidence base suggests there are multiple protocols in practise for second and subsequent Rituximab infusions; the manufacturer’s protocol as defined in the SPC and rapid administration policies over 60 and 90 minutes. These rapid infusion protocols are unlike the SPC’s administration policy and therefore considered off-label/ off license/unlicensed use of Rituximab.

This research project aims to determine which infusion protocol is most widely used in non-UK countries for second and subsequent infusion protocols in cancer patients without significant first infusion reactions. This research also aims to investigate the opinion of oncology/haematology pharmacists as the specialists in this area to ascertain the level of support for these new rapid infusion protocols.

Benefits and value of this research
This research will improve insight and awareness of clinical practise and the administration policies for Rituximab in non-UK oncology centres for cancer indications. Also, this research will give insight on the opinions of non-UK based oncology/haematology pharmacists regarding rapid infusion protocols as there is no previous research.

How the research will be carried out
The research will be conducted by contacting non-UK based oncology/haematology pharmacists. Their responses will be collected using online questionnaires available through Survey Monkey. The questions will relate to your institutions Rituximab administration policy for first infusions and those following. There will also be questions regarding your opinion of Rituximab infusion protocols in practise.

How the results be used and published
All collected questionnaire responses will be analysed independently and the data extracted. The results will be the core of my final dissertation project’s written paper and will be presented to members of the University of Wolverhampton faculty, including project supervisor - Bruce Burnett.

The participant’s role
All non-UK oncology/haematology pharmacists participating in this study will be asked to complete an online questionnaire hosted by Survey Monkey.

Anonymity, confidentially and foreseeable risks
Questionnaire responses will be kept securely on a password protected USB which will be accessed by the researcher alone. As of yet there are no foreseeable risks from taking part in this research project.

Details of how information will be held and disposed of
All responses will be accessible and analysed by the researcher alone and stored on a password protected USB. Within 6 months of completing of the research project the USB will be formatted to remove all collected data.