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What are the responsibilities of an ethics committee (EC) for review of advertisements (Ads) for clinical trial participants?
Varsha Ramanathan
Direct advertising for study participant is considered to be the start of the informed consent and subject selection process. Advertisements should be reviewed and approved by the EC as part of the documentation for initial review at a convened meeting of the EC. The EC should be aware of potential promotional aspects of the consent-related documents.
When direct advertising is to be used, the EC should review the information contained in the advertisement and the mode of its communication, to determine that the procedure for recruiting participants is not coercive and does not state or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol.
The EC should also review the final copy of printed advertisements to evaluate the relative size of font/type used and other visual effects. When advertisements are to be recorded for broadcast or a website, the EC should review the final audio/video recording. The EC would expect the clinical investigators to obtain EC approval of message text prior to recording, Advertising for recruitment into investigational drug, biologic or device studies should not use terms such as ‘new treatment,’ ‘new medication’ or ‘new drug’ without explaining that the test article is investigational or experimental.
Advertisements should not promise "free medical treatment," when the intent is only to say subjects will not be charged for taking part in the investigation. Advertisements may state that subjects will be paid but should not emphasize the payment or the amount to be paid, by such means as larger or bold type.
No claims should be made, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation, or that the investigational product or test article is known to be equivalent or superior to any other drug, biologic or device.
What are good practices regarding e-mail communication between sponsor’s team and investigator site?
Dr Malini Jadhav
E-mail systems, when used properly, should have controls to ensure:
• limited system access through individual user accounts/passwords.
• the confidentiality of information contained in messages/attachments.
• user authentication (i.e., by using e-mail, the sender is generating an electronic signature.
If an email communication would have an impact upon the respective study, then it would be appropriate to maintain a record of that communication and/or decision.
Returning the emails to site by burning them to a disk in PDF format is acceptable for regulatory purpose.
What are the FDA expectations regarding the availability of Principal Investigator (PI) during clinical investigator site inspection if he/she has retired or closed his/her clinic and is not practicing medicine?
Shivani Vakharia
If the Principal Investigator has retired and has stopped practicing medicine, the FDA does not expect him/her to return to be part of the inspection. If the records have been transferred to the custody of the sponsor, then FDA would work with the sponsor to inspect the records. However, the FDA would expect the medical records to be available as part of the inspection when necessary.
What are responsibilities of an EC for review of advertisements for clinical trial participants?
Varsha Ramanathan
Direct advertising for study participant is considered to be the start of the informed consent and subject selection process. Advertisements should be reviewed and approved by the EC as part of the documentation for initial review at a convened meeting of the EC. The EC should be aware of potential promotional aspects of the consent-related documents.
When direct advertising is to be used, the EC should review the information contained in the advertisement and the mode of its communication, to determine that the procedure for recruiting participants is not coercive and does not state or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol.
The EC should also review the final copy of printed advertisements to evaluate the relative size of font/type used and other visual effects. When advertisements are to be recorded for broadcast or a website, the EC should review the final audio/video recording. The EC would expect the clinical investigators to obtain EC approval of message text prior to recording, Advertising for recruitment into investigational drug, biologic or device studies should not use terms such as "new treatment," "new medication" or "new drug" without explaining that the test article is investigational or experimental.
Advertisements should not promise "free medical treatment," when the intent is only to say subjects will not be charged for taking part in the investigation. Advertisements may state that subjects will be paid but should not emphasize the payment or the amount to be paid, by such means as larger or bold type.
No claims should be made, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation, or that the investigational product or test article is known to be equivalent or superior to any other drug, biologic or device.
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