Patient Recruitment
The purpose of the Patient Recruitment stop is to recruit patients to become aware of and seek to participate in the study.
Description
Patient recruitment is the process of identifying and enrolling eligible participants in a clinical trial.
Patient recruitment is a critical step in the clinical trial process to identify and enroll a sufficient number of participants to ensure that the trial is statistically powered to detect a difference between the intervention and control groups. The best method for recruiting patients for a clinical trial will vary depending on the type of trial and the target population. However, all methods should be used in a way that is ethical and respectful of potential participants. Methods that can be used to recruit patients for clinical trials, include:
- Direct contact: This involves contacting potential participants directly by phone, mail, or email.
- Public awareness campaigns: This involves raising awareness of the clinical trial through advertising, social media, or other public outreach methods.
- Collaboration with healthcare providers: This involves working with healthcare providers to identify and refer potential participants to the clinical trial.
- Patient registries: This involves using patient registries to identify potential participants who meet the key eligibility criteria for the clinical trial.
DCT-specific Considerations/Inputs
Traditional clinical trials often rely on clinical research sites to recruit patients. However, DCTs require a multi-channel approach to reach a wider range of patients. This may include using online advertising, social media, and patient advocacy groups. Ideally, patients and sites are included in the development of any patient recruitment tactics and materials to ensure they are useful and the information shared about the trial is aligned to patients' needs and interests.
By using a multi-channel approach to patient recruitment, sponsors and investigators can help to ensure that DCTs are able to recruit the patients needed to answer the scientific questions of the study, in a reasonable time frame.
Tools
Reference Documents
MRCT IRB/EC Considerations - Full Document
ViewMRCT IRB/EC Considerations - Recruitment
ViewMRCT IRB/EC Considerations - Helpdesk
ViewMRCT IRB/EC Considerations - Notifications & Reminders
ViewCTTI Understanding Clinical Trial Recruitment Rules
ViewCTTI Recommendations: Planning for Successful Trial Recruitment
ViewCTTI Planning RWD-Supported Recruitment Strategies
ViewCTTI Resource: HOW TO MONITOR RECRUITMENT PROCESS & PERFORMANCE
ViewNIH - Informed Consent for Research Using Digital Health Technologies
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