Essential documents Deep Dive: Advertisements
Hart’s Good Clinical Practice glossary series
Welcome back to the Hart GCP knowledge series. We have been reviewing essential documents that are typically generated before the clinical phase of the trial begins. We have looked specifically at the Investigator brochure and clinical protocol/protocol amendments and informed consent tracking in this portion of our glossary series.
The Good Clinical Practice (GCP) guideline states that an advertisement in a clinical trial is used for subject recruitment. These documents must be reviewed by the IRB/EC and filed in the Investigator’s portion of the trial master files. Thorough review and documentation of these files is required “to document that recruitment measures are appropriate and not coercive.”
Another guidance from FDA regarding recruiting study subjects provides direction on direct media advertising of potential research participants as well as receptionist scripts. Direct advertising is any form of communication that is intended to be “seen or heard by prospective subjects” for soliciting their participation in a study. As long as these materials are accurate and are not coercive, this type of recruitment is not objectionable. Advertisements include things like flyers, posters, and bulletin board postings, but also may include newspaper, radio, or television ads. Recruitment materials for health professionals, like “dear doctor” letters or articles intended for the general public, like news stories, do not fall under the description of study recruitment “advertisements”.
Any communication with a prospective study participant is required to be reviewed by an IRB in order to confirm that the wording does not unduly influence the individual. Undue influence can include leading the subject to believe they will be receiving a newly approved drug, by using words like “new treatment” instead of “investigational treatment” or by making promises of “free medical treatment”, when the actual scenario is that the subject won’t be charged to participate in the study. Another regulatory no-no is to make any claim about the investigative product, either implicitly or explicitly, that the treatment is safe or effective for the purposes used in the study or that it is the same or better than any other treatment.
Generally, an advertisement should contain the following types of information:
- Name and address of the clinical investigator and of the research site
- Purpose of the research
- Study eligibility criteria
- Benefits of participation
- Commitment required of the subject
- Location of the research
- Who to contact
This guidance provides general information on internet advertisements, but we will address the use of social media in clinical trials in an upcoming post (stay tuned!). Until then, look here for some tips on social media in clinical studies.
Thank you for reading HCC’s glossary series! Next time we will continue to examine key essential documents by looking at insurance requirements for a trial in the US.