The following are some frequently asked questions:
Is there any funding provided by the Sponsor to recruiting sites?
The BASIL-2 operating model has changed and we are now supplying funding to all participating sites at the rate of £600 per patient. £400 on recruitment and £200 on final data received for each patient.
Should the MDT deciding eligibility be in equipoise regarding the interventions?
Look out for next substantial amendment for changes. But currently yes, MDT should be deciding eligibility. Like all randomised controlled trials, it is essential for equipoise to exist towards all arms of the trial. If any particular arm is considered preferential for any particular patient, then they should not be offered the trial and they must be treated in accordance with the considered clinical judgement.
What do BASIL-2 patient’s look like, clinically?
Take a look at our example angiograms from actual BASIL-2 Trial participants
How will it work?
Information will be collected from all participants for a minimum of two years and a maximum of 8 years after entering the study. At the end of this time the information will be analysed to see if one of the treatments is better than the other.
Who is funding the study?
Basil-2 is funded by NIHR Technology Assessment, grant number 12/35/45
When will we get results?
Follow-up was completed on 30 November 2022. Results will be published in Spring 2023. Results will be posted on the Basil-2 website and a summary provided to all recruiting sites.
Contact
The Trial Manager for Basil-2 is Suzanne Lockyer, email Basil-2@trials.bham.ac.uk