Clinical Trial Recruitment Materials
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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.
-
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.
Good Morning @munitalp
As the recruitment piece is not target to HCPs, there should be no reference to the manufacturers product, generic name or brand name. Furthermore, the copy should not state the company name. It should be limited to something similar to “a Canadian manufacturer” and “investigating a product”. The trial name, study acronym or logo can be easily linked to the company and products and therefore would also not be acceptable for a clinical trial recruitment piece under the distinction document.
Inclusion criteria which restrict to patients which have had prior treatment with specific products can be referred in a non-promotional way.
