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Compliance In Focus
Posted by Brandy Smith on Thu, Sep 13, 2012

How Can You Bolster Clinical Trial Enrollment?

Your site is weeks past study initiation and all the candidates that you expected to be screeningrecruiting subjects for clinical studies for the study have not materialized.  Would trial-related advertising or recruitment materials enhance your sites' enrollment efforts? 

Compliance with 21 CFR Part 56, Institutional Review Board Regulations, is intended to protect the rights, safety and welfare of human subjects participating in clinical investigations.  This protection extends to recruitment of potential research subjects.  FDA expects study-related advertising materials to be reviewed by the IRB to ensure that they are non-coercive and that there’s no promise of test article safety or effectiveness (which remains to be established).  This is of particular importance when the target study population includes subjects who may be vulnerable to undue influence.  Complying with 21 CFR 56.109(b) requires that information given to subjects as part of the informed consent process is in accordance with §50.25.  Ideally, advertisements planned to be used in subject recruitment should be submitted for IRB review in the initial study submission package.

In their Information Sheet Guidance on Study Subject Recruitment, FDA considers direct advertising for study subjects as the start of the informed consent process. Direct advertising includes but is not limited to: radio and television spots, newspapers, magazines, bulletin board postings, study posters and flyers.  Some in the clinical research arena are exploring the feasibility of using social media for subject recruitment.  We posted a recent blog on using social media for subject recruitment.

It is interesting that internet recruitment postings, when limited to providing only basic study information, are not required to undergo prospective IRB review.    Examples of basic study information include:

  • Title and purpose of the study
  • Protocol summary           
  • Study site locations
  • Basic eligibility criteria
  • How to contact participating  sites for additional information

If study enrollment lags, sites may decide that recruitment materials are needed to attract attention to the trial.  These materials should be submitted as an amendment to the study and must undergo IRB review and approval prior to use.   In many cases, recruitment materials may qualify for expedited review, in accordance with §56.110 and the Standard Operating Procedures of the reviewing IRB.

The IRB should review the final copy of printed materials paying close attention not only to the language in the advertising. No claims can be made, nor can the test articles be referred to as “the same or better than” other products.  Even investigational product descriptors such as “new treatment” or “new drug/device” should be avoided as these terms could be mis-leading and mis-interpreted by prospective participants as implying that the test product has already received marketing clearance/approval.

Regulation-compliant and IRB-approved recruiting materials may be “just what the doctor ordered” when it comes to communicating clinical trial information to prospective participants.   Have you ever used recruitment materials for a study and what was your result?   Please share your thoughts.

Photo Credit: FutUndBeidl

Topics: 21 CFR Part 56, FDA, Clinical Research


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