What is the ASCEND PLUS research study?

ASCEND PLUS is a major new research study that will test whether taking a daily tablet that contains semaglutide can help to protect people with type 2 diabetes from suffering heart attacks, strokes and other cardiovascular events.

ASCEND PLUS will invite people aged 55 years and older, who have type 2 diabetes but have not suffered a heart attack or stroke in the past, to take part. Participants will be asked to take tablets containing semaglutide or inactive placebo tablets (which look like the semaglutide but have no active drug in them) for about five years.

You can learn more about the research study and who is eligible to take part on the ASCEND PLUS website. 

NHS England has been asked to identify people who may be eligible and to invite them to join the ASCEND PLUS research study. We will use the data we hold to identify potentially suitable people and contact details will be securely passed to Paragon Customer communications who will send an invitation letter. The data used will include name and address. Your personal data will not be shared directly with the research study team.

To manage the invitation process, we will need to keep the list of people who have been invited until six months after the research study recruitment is complete. This is to ensure that you are not invited if you have told us you do not want to be contacted.

After this time, all the information stored for the purpose of this research programme will be deleted. You can find out more about your choices on how the NHS uses your data for research and planning. 

We will use your data to produce summary reports to monitor recruitment into the research study (for example how many people were invited). These reports will not identify you personally.

As an executive non-departmental body reporting to the Department of Health and Social Care most of our processing activity is directed by the Secretary of State for Health and Social Care. NHS England is Directed under the pilot NHS DigiTrials recruitment support services directions 2021 to process data to identify potentially eligible participants to take part in the research study.

Additionally, the Health Research Authority has provided legal support to the ASCEND PLUS research study under Section 251 of the NHS Act 2006 and Regulation 5 of The Health Service (Control of Patient Information) Regulations 2002 which enable the common law duty of confidentiality to be temporarily lifted so that confidential patient information can be processed by NHS England on behalf of the research study. This support provides the legal basis for suitable participants to be invited to join the research study. This is following advice from the Confidentiality Advisory Group, an advisory body which provides independent expert advice on the use of confidential patient information without consent in England and Wales.

If you have requested that your NHS data is not shared for research and planning purposes (by registering a National Data Opt-out) then you will not receive an invitation for this research study.

To read more about the health and care information NHS England collects, our legal basis for collecting this information and what choices and rights you have, see how we look after your health and care information and our general transparency notice and the related GPDR register entry. 

If you do not want to be invited by NHS England to take part in the ASCEND PLUS research study, please complete our online opt-out form or call the ASCEND PLUS team on 0808 164 5090.

The team will complete the form on the NHS England website on your behalf and will not record your details in the University of Oxford database.

NHS England processes and holds the opt-out list on behalf of ASCEND PLUS.

If you've previously opted out of sharing your health data for planning and research purposes by submitting a National Data Opt Out, you do not need to take any action. You will not be invited to take part in this research study by NHS England.