We recommend you review Penn IRB’s Guidance Page on Recruitment of Human Participants before protocol writing.
Failure to recruit participants to meet enrollment goals of study continues to be the Achilles Heel in clinical research conduct and study completion. We discuss recruitment resources and strategies available to research teams at Penn Medicine, in these sections.
Research participants or patients have various motivations to seek out and participate in clinical research.
Direct medical benefit; especially for rare diseases or cancer where other known treatments have been exhausted.
Participation in research studies offer patients greater levels of care (such as more frequent monitoring) than in regular standard of care setting.
Furthering science for societal benefit
Participation in studies recommended by their health care provider.
Payment for participant time and effort are also significant drivers in research participation
It is recommended that investigators and teams plan recruitment and retention strategies at time of grant and / or protocol writing.
Privacy Considerations, Covered Entity while Recruiting
Research is one of Penn Medicine’s core missions. Patients are informed of this mission, the ability to use and disclose PHI under oversight by IRBs, and the choices to opt out of Research contact and health information exchange, through the Notice of Privacy Practices or NPP
Patients are able to indicate their choice to be opted out of being contacted for research recruitment in their medical record. Read more here.
Planning Recruitment for Your Protocol
Confirm your protocol’s target audience or population. Recruitment strategy should align with your target populations disease condition, locations they may frequent for care, ancillary life choices based off patients’ diagnosis, and outreach to the wider community that may be impacted by the condition you are studying.
A clinical research or trial protocol will also drive how teams strategize. Look for the following sections in the protocol- Background, Population, Eligibility criteria, Recruitment, compensation, confidentiality, data storage, and the Informed Consent document. All these should inform recruitment strategy.
Understand the location and logistics of where your target population frequents. For example- work with the principal investigator, the practice manager at the clinic, that may see patients or caregivers routinely in clinic, to obtain background and context for your target population. Recruitment strategies should be based off that knowledge
If you are writing your own protocol, consider making eligibility criteria as less restrictive as possible- this may need you to work with your PI to ensure safety or data scientist to ensure integrity of your protocol.
If you are implementing an industry or pharmaceutical sponsored research study, include recruitment as part of the protocol’s feasibility check. If the protocol has already been implemented fall back on the protocol and consent to address recruitment.
Meet frequently as a team, with your principal investigator, co-recruiters, project manager to discuss recruitment strategies, goals and timepoints.
A good rule of thumb is to come up with 2-3 strategies, implement, track whether a particular strategy is bang for buck, and re-strategize.
Recruitment Strategies & Resources
These have been categorized into the following methods:
- List research study/ trial on Penn Medicine’s Clinical Research Finder site, Penn iConnect
- List on Department/ Center or Institute website
- List on physician's hospital profile
- Print advertisements/ Mixed Media
- Flyers (pull tab or Q-code),
- Local Ads, Newspapers, Magazines
- SEPTA ads, Indego bike share ads
- In-Clinic Recruitment
- Physician Referrals (within and related departments)
- Network with other practices and clinics
- Electronic Medical Record (EMR) -PennChart
- Patient Recruitment Management System – Penn iConnect
- Email, Mail, Patient Portal, Phone
- Dear Physician, Dear Patient emails, letters
- Emails to potentially eligible patients via the Electronic Medical Record.
- MyPennMedicine recruitment
- Phone (cold-calls- allowed but least encouraged)
- Social Media
- ClinicalResearch@Penn Facebook page
- Penn Medicine Facebook page
- PennCancer Facebook page
- Mobile Apps
- App Bakery, Way2Health
- Telehealth/ Telemedicine