Unblinding for India

Participants in the Add-Aspirin trial take either 100mg aspirin, 300mg aspirin or a matched placebo, once daily for approximately five years. Add-Aspirin is a double-blind trial. This means that neither the participant nor their doctors will know which treatment they have received.

Almost all clinical scenarios can be managed by assuming a trial participant is taking 300mg of aspirin once a day and withholding the trial medication. We only expect unblinding in the Add-Aspirin trial to be necessary in rare clinical circumstances where knowledge of treatment allocation is essential to guide clinical management.
Guidance on a number of anticipated scenarios with specific advice about the need to unblind can be found here.

If unblinding is felt to be clinically essential for a participant in India, designated individuals at Tata Memorial Centre Mumbai (TMC) and JSS are able to find out a participant’s treatment allocation through the unblinding system. Where unblinding is being considered, contact should be made with  the JSS team in the first instance and – where appropriate - they will contact the clinical leads at TMC to discuss the case.

To contact JSS
Dr Neeraj Prasad: +(91)9930740633; +(91)1296613500  (24/7)
safety@jssresearch.com

Designated individuals at TMC and JSS can directly access treatment information in an emergency using the link below, and entering their email address in addition to the participant’s trial number and date of birth. The participant’s trial number can be found on their Add-Aspirin trial card. Unblinding details will be sent to the email address provided.

UNBLINDING SHOULD ONLY BE CONSIDERED WHERE KNOWLEDGE OF TREATMENT ALLOCATION IS ESSENTIAL TO GUIDE CLINICAL MANAGEMENT

Unblind an India participant