Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Author:  Sreedhar Tirunagari, MD

Human subject recruitment is crucial for the success of any clinical trial and can be a challenging to Sponsors and investigators, hence they use four main strategies to recruit human subjects and encourage timely recruitment.

•  Sponsors offer financial and other incentives to investigators to boost enrollment.
•  Investigators target their own patients as potential subjects.
•  Investigators seek additional subjects from other sources such as physician referrals and disease registries.
•  Sponsors and investigators advertise and promote their studies.

To achieve timely recruitment for clinical trial the consent process may be undermined when, under pressure of quick recruitment like patients are influenced to participate in research due to their trust in their doctor. Some physicians searching medical records, disease registries, school records, or mailing lists by compromising confidentiality and then contacting a patient about participation. Some times there may be chance of enrollment of Ineligible Subjects in order to meet quotas and satisfy sponsors.

Most IRB’s are not reviewing many of the recruitment practices that they and others find most troubling. IRBs’ limited review of recruitment practices is in part due to their perceived lack of authority to review certain practices in their own oversight of research sites, sponsors pay minimal attention to how human subjects are recruited.

Role of IRB:
IRBs should concentrate on human subject recruitment consent process; how they are enrolled in to study and human subject protection and confidentiality is maintained. Few recommendations suggested by the Department of Health and Human Services in its report can be adopted to ensure essential human-subject protections without unnecessarily slowing the pace of research and discovery.

•  IRB should be provided with direction regarding oversight of recruitment practices.

IRB should be given authority to review recruitment practices, Regulatory bodies should disseminate guidance explicitly stating this authority based on IRBs’ established authority to ensure informed consent and review anything related to human-subject protections.

Regulatory bodies should also suggest a recruitment question to the IRB’s that they should address in their protocol reviews and should foster discussion about these issues.

•  Development of guidelines for all parties on appropriate recruiting practices :

Determination of appropriate recruiting practices would be helpful for all parties like; sponsors, investigators, and IRBs. It is essential that this determination be made cooperatively with industry and the research community. As part of their deliberations, these parties could explore such questions as:
• Is it acceptable for sponsors to offer bonuses to investigators for successfully recruiting subjects?
• Should physicians be allowed to receive fees for referring their patients as potential subjects for a clinical trial?
• Should the financial arrangements between sponsors and investigators be disclosed to potential subjects?
• Do searching medical records for potential subjects constitute a breach of confidentiality?

•  IRBs and investigators should be adequately educated about human-subject protections :

• Investigators should be educated as a prerequisite for conducting research under regulatory guidelines.
• IRBs should develop training program for members.
• Require more extensive representation on IRBs of nonscientific and non- institutional members. Such members can help sensitize IRBs to patient concerns about recruitment practices.

•  Strengthen Regulatory body oversight of IRBs :

• All the IRBs should be registered with the Country specific regulatory bodies.