GCP Guidance on Patient Recruitment
Regulatory Guidelines
The patient recruitment pathway extends from the public domain until the point at which an individual joins the study. It encompasses a number of different components including:
- Promotion and awareness of trials
- Sending expressions of interest
- 2-way communication with Trial Sites
- The informed consent process
- Study enrollment
Regulatory Guidelines
Much has been written about patient recruitment relating to an online context:
- ICH GCP Section 4
- National statement on ethical conduct in human research
- The Declaration of Helsinki
- The Privacy Act 1988
- Terms of use and privacy policy of other websites (e.g. Facebook)
What are the principles of GCP in this context?
- Individuals have the right to know
- Individuals have the right to be safe
- Interactions need to be complete, accurate, and ethical
- Appropriate risk assessments must be done
All these principles are in place to protect everyone involved in clinical trials including you! That includes participants, Trial Site staff, and Sponsors.
Further thinking about patient recruitment
Communication during patient recruitment is key, as the entire process is dependent on how information flows between each of the involved parties:
- Who is responsible for what sort of communication
- Be aware of the boundaries and requirements separating pre-screening, informed consent, and screening
- Ensure you hold your communication to the highest standards (clarity and ethics)
- GCP requires you not to be coercive, but marketing’s goal is to get people to consider what they would not usually
- Balance these two factors to create engaging material that raises awareness, but does not unduly influence
- In the end, it must be left up to the individuals to decide whether to participate