Hello,
Our company is interested in creating patient-directed clinical trial recruitment materials that would be provided to potential subjects by clinicians or made available at digital conferences. The ongoing trial is for a marketed product in combination with another marketed agent and the inclusion criteria include prior therapy with other agents.
To aid consumer understanding, we would like to refer to our product ingredient (not our marketed name) and the product/marketed names for the agents that will be used in combination as well as list the product/marketed names of the drugs in the inclusion criteria.
The HC Guidance on 'The distinction between advertising and other activities' states that a recruitment announcement should not reference the name of the drug under investigation or the manufacturer. Does the guidance refer to the use of our trade name or the active ingredient as well? Is this restricted to the inclusion criteria as well?
Also, does the use of the trial name (DESTINY, ASCOT, KEYNOTE) or logo in a clinical trial recruitment piece render it promotional?
Thank you in advance.