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Guideline for Clinical Trial Advertisement/Recruitment Programme

The Ethics Committee (EC) of the trial institution is responsible for reviewing all the trial documents and activities that bear directly on the rights and welfare of the subjects of proposed clinical trials. Examples of the documents that the EC should review are the protocol, the consent form, the investigator's brochure and subject recruitment procedure.

One method of recruiting subjects is through advertisements. Advertising for trial subjects is not in itself an objectionable practice. However, when advertising is to be used, the EC should review the information contained in the advertisement and the mode of its communication.

EC review is necessary to ensure that the information contained in the advertisement is not misleading and that the procedure for recruiting subjects gives adequate protection for the rights and welfare of the subjects. This is especially important when a trial will involve persons with acute or severe physical or mental illness or persons who are economically or educationally disadvantaged.

Generally, the content of any advertisement to recruit subjects should be limited to:

  • The name and address of the clinical investigator;
  • The purpose of the trial and, in summary form, the eligibility criteria that will be used to admit subjects into the trial;
  • A straightforward and truthful description of the benefits (eg. payments or free treatment) to the subject from participation in the trial; and
  • The location of the trial and the person to contact for further information.

No claims should be made, either explicitly or implicitly, that the drug is safe or effective for the purposes under investigation, or that the drug is in any way equivalent or superior to any other drug.

Note: The above guideline is adapted from the US FDA's guideline - Advertising for Study Subjects (October 1994).


Last updated on 02 Jul 2010 16:42:23
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